Category Archives: Drug Development

Method to predict drug stability could lead to more effective medicines

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Researchers have developed a new method to predict the physical stability of drug candidates, which could help with the development of new and more effective medicines for patients.

Researchers from the UK and Denmark have developed a new method to predict the physical stability of drug candidates, which could help with the development of new and more effective medicines for patients. The technology is being developed for use in the pharmaceutical industry in order to make medicines that are more easily released into the body.

The researcher’s method solves an old problem: how to predict when and how a solid will crystallise. Using optical and mechanical measuring techniques, they found that localised movement of molecules within a solid is ultimately responsible for crystallisation.

Solids behave differently depending on whether their molecular structure is ordered (crystal) or disordered (glass). Chemically, the crystal and glass forms of a solid are exactly the same, but they have different properties.

Molecules in the glass form are more readily absorbed by the body because they can dissolve more easily

One of the desirable properties of glasses is that they are more soluble in water, which is especially useful for medical applications. To be effective, medicines need to be water-soluble, so that they can be dissolved within the body and reach their target via the bloodstream.

“Most of the medicines in use today are in the crystal form, which means that they need extra energy to dissolve in the body before they enter the bloodstream,” said study co-author Professor Axel Zeitler from Cambridge’s Department of Chemical Engineering & Biotechnology. “Molecules in the glass form are more readily absorbed by the body because they can dissolve more easily, and many glasses that can cure disease have been discovered in the past 20 years, but they’re not being made into medicines because they’re not stable enough.”

After a certain time, all glasses will undergo spontaneous crystallisation, at which point the molecules will not only lose their disordered structure, but they will also lose the properties that made them effective in the first place. A long-standing problem for scientists has been how to predict when crystallisation will occur, which, if solved, would enable the widespread practical application of glasses.

“This is a very old problem,” said Prof Zeitler. “And for pharmaceutical companies, it’s often too big of a risk. If they develop a drug based on the glass form of a molecule and it crystallises, they will not only have lost a potentially effective medicine, but they would have to do a massive recall.”

In order to determine when and how solids will crystallise, most researchers had focused on the glass transition temperature, which is the temperature above which molecules can move in the solid more freely and can be measured easily. Using a technique called dynamic mechanical analysis as well as terahertz spectroscopy, Prof Zeitler and his colleagues showed that instead of the glass transition temperature, the molecular motions occurring until a lower temperature threshold, are responsible for crystallisation.

These motions are constrained by localised forces in the molecular environment and, in contrast to the relatively large motions that happen above the glass transition temperature, the molecular motions above the lower temperature threshold are much subtler. While the localised movement is tricky to measure, it is a key part of the crystallisation process.

Given the advance in measurement techniques developed by the Cambridge and Copenhagen teams, drug molecules that were previously discarded at the pre-clinical stage can now be tested to determine whether they can be brought to the market in a stable glass form that overcomes the solubility limitations of the crystal form.

“If we use our technique to screen molecules that were previously discarded, and we find that the temperature associated with the onset of the localised motion is sufficiently high, we would have high confidence that the material will not crystallise the following manufacture,” said Prof Zeitler. “We could use the calibration curve that we describe in the second paper to predict the length of time it will take the material to crystallise.”


Launch of first breast cancer biosimilar in the UK

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MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.

Biosimilar trastuzumab represents the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd.

The European Medicines Agency (EMA) requires biosimilars to show they are highly similar to the reference medicine in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Ontruzant (trastuzumab biosimilar (SB3)) is a monoclonal antibody and has been shown to have similar safety and efficacy as its reference product Herceptin (TRZ) in early breast cancer, with breast pathologic complete response rates (bpCR) being 51.7% and 42.0% with SB3 and TRZ respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The overall response rates were 96.3% and 91.2% with SB3 and TRZ.

Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the deputy lead clinician for breast cancer in the North of England Cancer Network said, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

Denise Blake, Senior Lead Clinical Pharmacist at Newcastle Hospitals, explains, “The introduction of biosimilar trastuzumab provides an opportunity for the NHS to realise substantial financial savings without compromising patient care. Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice.”

“As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis,”explains Louise Houson, UK Managing Director, MSD.

Regulatory approval was based on a Phase III study that compared SB3 with reference TRZ in patients with human epidermal growth factor receptor HER-2 positive early breast cancer in the neoadjuvant setting.

The study showed the total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within pre-specified equivalence margins and the upper limit of the confidence interval slightly exceeding the pre-specified equivalence margins (-13%, 13%).

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.


How thalidomide is effective against cerebral infarction

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Scientists reveal that this dangerous drug could suppress nerve cell death.

Notoriously remembered as a major pharmaceutical scandal approximately 60 years ago, thalidomide caused severe birth defects when many pregnant women took the drug as a remedy for their morning sickness.

In recent years, however, thalidomide and its derivatives have been widely used to treat haematologic malignancies such as multiple myeloma.

Evidence also suggests that thalidomide has a neuroprotective effect, reducing both oxidative stress and inflammatory response, but the exact molecular mechanisms of thalidomide on the brain were unknown.

To investigate, scientists at Waseda University and Tokyo University of Pharmacy and Life Sciences studied thalidomide’s target protein, cereblon (CRBN), and its binding protein, AMP-activated protein kinase (AMPK), which plays an important role in maintaining intracellular energy homeostasis in the brain.

Through their study, they revealed that thalidomide inhibits the activity of AMPK via CRBN under oxidative stress and suppresses nerve cell death.

“We hope that our findings will help with the development of new and safer thalidomide derivatives,” says Naoya Sawamura, Associate Professor of Neuropharmacology at Waseda University and leading author of this study, “to better treat diseases such as cerebral infarction, a type of stroke, which is a major cause of death worldwide.”

Specifically, Sawamura’s research group used cerebral ischaemia model rats of the cerebral artery occlusion/reperfusion (MCAO/R) to examine the effect of thalidomide on infarct lesions caused by cerebral ischaemia and related intracellular signals.

After performing qualitative analysis and assessments on the rats’ physical movements, they found that thalidomide treatment significantly decreased the infarct volume and neurological deficits in MCAO/R model rats, and that AMPK was the key signalling protein in the mechanism through additional experiments.

Moreover, to determine the molecular mechanisms of the effect of thalidomide on neuronal death, they used oxidative stress-induced neuronal cells, which were induced by administration of H2O2, as cerebral ischaemia model cells.

“In these cells, we found that the AMPK-CRBN interaction weakened and phosphorylation of AMPK enhanced, but thalidomide treatment restored the AMPK-CRBN interaction and suppressed phosphorylation of AMPK,” explains Sawamura.

“What this implies is that thalidomide regulates AMPK-CRBN interactions in cells under ischaemic conditions, meaning, it can suppress nerve cell death.”

Further study is needed to identify effective thalidomide derivatives with fewer side-effects, as well as more stability because they undergo hydrolysis spontaneously and rapidly in aqueous solutions.

Nevertheless, Sawamura is excited about the future possibilities of this study.

“Our attention is now on the functions of CRBN as a stress response molecule. The suppression of nerve cell death by thalidomide perhaps occurs because CRBN’s function as a stress molecule is somehow enhanced.”

“We want to elucidate the response of cereblons in ageing and stress models to see if decline in the CRBN function could be a biomarker for ageing and stress.”


Sanofi, Evotec in major infectious disease R&D transfer and license deal

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Big Pharma Sanofi and German CRO-biotech drug discovery hybrid Evotec are penning a deal that will see Sanofi license out a host of infectious disease assets to the biotech, with 100 staffers also moving into its R&D engine.

Sanofi is paying a one-time, upfront fee of €60 million ($74 million) to Evotec, a small sum, but one backed up with a promise to “provide significant further long-term funding to ensure support and progression of the portfolio,” although exact financial details were not shared.

The deal drills down like this: Sanofi will license most of its infectious disease (ID) research and early-stage portfolio (around 10 assets all-told) and move this unit, with around Sanofi 100 staffers alongside it, into Evotec (although this does not include the French pharma’s vaccine R&D unit).

Evotec, which does its own research and also relies heavily on external collaborations with biopharmas and academic biomedical research, will run this “open innovation platform” near Lyon, France, where Sanofi Pasteur is HQ’d.

Sanofi holds on to certain option rights on the development, manufacturing, and commercialization of anti-infective products and will “continue to be involved in infectious disease through its vaccines research and development and its global health programs,” it says in a statement.

The focus of the Evotec drug discovery will be on “new mode-of-action antimicrobials,” the pair say.

Werner Lanthaler, Ph.D., CEO of Evotec, said: “Since the acquisition of Euprotec (UK) in 2014, Evotec has had a significant strategic interest and demonstrated expertise in infectious diseases research, with an ambition to grow and become the drug discovery and development leader in this space together with its partners.

“We are pleased to be working and expanding our strategic relationship with Sanofi, which has a long history in providing novel anti-infective agents to markets globally. Finding a way to motivate more public funding and academic initiatives for the progress of novel anti-infectives on Evotec’s platform will be a key success factor for this initiative.”

The deal is still being talked over, but should be done in the coming months.

Evotec already has a series of deals with the likes of Eli Lilly, Tesaro, Oxford University, and even has its own spin-out in the form of Topas Therapeutics.

Elias Zerhouni, M.D., president of global R&D for Sanofi, adds: “Research in the field of anti-infectives is an area where building critical mass through partnering is particularly important. This new French-based open innovation center will benefit from the high-quality science ecosystem. Evotec is a trusted partner in drug discovery and has the ambition and capacity to become a real leader in the fight against infectious diseases.”

This also comes as Sanofi continues to retool its R&D, getting back into cancer as well as blood disorders via its $11.6 billion deal for Biogen spin-out Bioverativ.


Diabetes tablet passes Phase III clinical trial

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As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative.

In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

Novo Nordisk’s semaglutide however permanently lowers blood glucose levels by increasing insulin production and could also treat obesity, a major underlying cause of diabetes. A recent study showed that the drug controls appetite and food cravings and could therefore generate significant weight loss.

First developed in 2012, an injectable version of semaglutide is already approved for use in the US. Now, an oral version of the drug has now passed its first Phase III clinical trial.

Semaglutide works by mimicking the action of a hormone (GLP-1) which increases insulin secretion. It can be taken orally once daily and in this 6-month trial was delivered in 3, 6 and 14 mg doses to over 700 people with type 2 diabetes.

The drug showed significant reductions in long-term blood glucose levels compared to placebo at all doses, while the highest dose also led to significant weight loss. People treated with 14mg semaglutide experienced a weight loss of over 4 kg on average.

The drug was also safe and well tolerated, causing only nausea, which reduced over time. Chief Science Officer of Novo Mads Krogsgaard Thomsen said he was encouraged by the results of the trial, adding “[The results] confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes”.

There are nine additional trials running for semaglutide with over 9000 participants, results for which will be provided later this year. Novo Nordisk plan to apply for regulatory approval for the drug in 2019.


Green Leaf Farms receives expanded cultivation site approval

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US manufacturer of cannabis products has begun operations in a state-of-the-art facility.

Green Leaf Farms, a US-based manufacturer of medical and recreational cannabis products, has received approval for expansion of its state-of-the-art facility and commencement of operations in an additional cultivation site.

Both sets of permits were tied together, the company said, due to the complexity of the structural and mechanical engineering that was needed to integrate the operations.

Based in Denver, Green Leaf Farms is a Division of Player’s Network (PNTV). The company took home the approved building permits for Phase Three development of its production and cultivation build-out, and officially began operations in an 8000 ft2 cultivation room. The site was completed last November.

According to PNTV, the expanded building has been designed to develop new products that will differentiate Green Leaf Farms in the emerging legal marijuana industry.

The expansion includes a state-of-the-art cleanroom, genetics lab, development laboratory, an extraction facility, a commercial kitchen, product development space, automated water purification including custom dosage and nutrient centre, a bio-testing facility, curing, packaging, and media centre.

“These design approvals will allow Green Leaf Farms to complete its build-out and become what I believe will be among the most advanced marijuana production and cultivation facilities in the world,” said Mark Bradley, CEO at PNTV.

“We have combined technology with an amazing, creative workspace that will encourage innovation, product development, differentiation and operating efficiencies.”

Green Leaf Farms has announced that further details of the expanded cultivation and manufacturing facility will be disclosed in due course.


The third wave of AI in pharma R&D

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The capabilities of artificial intelligence are advancing and its ‘third wave’ offers the ability to analyse enormous sets of data, identify patterns, and generate algorithms to explain them, to the benefit of researchers.

The digital revolution vastly accelerated the research, development, and production of new drugs. Digital technology has augmented the natural capabilities of researchers and scientists in a variety of ways. Now, artificial intelligence (AI) is poised to take this augmentation to the next level.

One of the most significant ways in which AI technology augments human capacity – particularly in an R&D context – is by automating repetitive, lower-level cognitive functions that once had to be carried out manually. This liberates drug researchers to focus on higher-level thinking. This advantage was identified early in the development of AI technology by J C R Licklider, who wrote back in 1960 in Man-Computer Symbiosis:

“About 85% of my ‘thinking’ time was spent getting into a position to think, to make a decision, to learn something I needed to know. Much more time went into finding or obtaining information than into digesting it.”… “Several hours of calculating were required to get the data into comparable form. When they were in comparable form, it took only a few seconds to determine what I needed to know.”

A related idea was expressed by Herbert A Simon with the concept of ‘bounded rationality. He wrote that humans’ decision making can be optimised when they are provided with a limited quantity of relevant, focused information and sufficient time to process it.

With the advent of contemporary AI technologies, the bounds of human rationality have been expanded. AI provides drug researchers with a greater breadth and depth of data that is simultaneously more focused and relevant than the data sets of the past, enabling researchers to optimise their decision-making capacities.

The continued advancement of AI will augment humans’ power of critical thinking in three key areas that are relevant to the medical and pharmaceutical industries: computing advanced mathematical problems, analyzing complex statistics, and generating novel hypotheses. These areas correspond to the ‘three waves’ of AI development throughout the 20th and 21st centuries.

The first and second waves

The first wave of AI development brought us ‘knowledge engineering’ optimisation programs, which solved real-world problems efficiently.

While applications specific to the pharmaceutical industry were scarce, the broader medical field benefits from first-wave AI technologies every day. Take the Framingham Risk Score Calculator, which utilises AI to predict the heart disease risk of any patient.

Machine learning programs were brought along by the second wave of AI. These solve complex pattern recognition problems using statistical analysis. Unlike their first-wave predecessors, second-wave AI programs perceive and learn – often as well as humans do.

Clinical decision support systems use second-wave pattern-recognition programs to analyse and evaluate medical test results. Similar machine-learning programs are beginning to be used by leading pharma firms in a variety of research and development contexts to predict drug effectiveness, to discover new compounds with pharmaceutical qualities, and to develop new combinations of existing drugs.

Second-wave AI is powerful, but it demands well-organised, consistently-coded, and complete data sets in order to accurately conduct its analyses. This limitation is now being overcome by the third wave of AI.

The third wave

We have now entered the third wave of AI development. Third-wave AI programs have the capacity to analyse enormous sets of data, identify patterns, and generate algorithms to explain them. These programs normalise the context of disparate data points and generate original, novel hypotheses at a faster rate and with greater accuracy than human researchers can.

Only in this third wave have AI programs reached a sufficiently advanced state to effectively analyse the vast and complex web of unstructured biological data. Until recently, biological data had to be manually cleaned and organised through extensive and costly human effort. Now, AI programs use a combination of machine learning, natural language processing, and text analytics to analyse unstructured data in real-time.

Through context normalisation, third-wave AI technology dramatically increases the quantity of data that can be analysed in the course of the drug discovery and testing process. Furthermore, it enables the simultaneous generation and testing of new hypotheses at a rate that would be impossible without such immense computing power.

Aided by this technology, drug researchers can arrive at a higher quantity of more accurate hypotheses and can test these hypotheses with unprecedented speed. The result is a significantly faster, and less expensive, discovery process, with lower risk and more effective results. Firms such as Pfizer and Johnson & Johnson are employing such methods to great effect.

Given that R&D consumes as much as 20% of pharma firms’ revenues, and that the total price of developing a new drug has ballooned by 250% in the last 30 years, it’s not surprising that firms are eager to embrace third-wave AI as a means of accelerating drug development.


Amryt looking to expand rare disease franchise

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UK-based specialist Amryt Pharma is looking to expand in 2018 after acquiring two rare disease treatments.

A relative newcomer to the niche rare disease market, Amryt Pharma was founded by former Astellas medical director Joe Wiley and financier Rory Nealon in August 2015, who spotted an opportunity to develop products in under-served orphan disease therapy areas.

The Irish duo in-licensed their first product, Lojuxta from Aegerion in December 2016, and have since increased its revenues by more than 50%, as well as building a corporate team and European operations.

Lojuxta is licensed to treat the rare, life-threatening disease called Homozygous Familial Hypercholesterolemia (HoFH), and Amryt has marketing rights for the drug in the EEA region, as well as Israel, Turkey and MENA markets.

The company also has in its pipeline AP101, a promising product candidate currently in a pivotal trial for epidermolysis bullosa, a rare and debilitating skin condition.

Amryt expect to bring the product to the US and European markets by 2020, and believe the global market to treat the condition is worth around $1 billion annually.

“This is an exciting time of growth and expansion for us. Rare disease companies often start up in the US and then enter the European market, but our origins mean we have a deep understanding of what’s required and the nuances of doing business in the pharmaceutical space in Europe,” said Joe Wiley.

“I believe we’re proving this with the significant growth we have delivered in the space of one year with Lojuxta.”

The privately-held company is expected to look for further growth this year, and this includes interest in further in-licensing deals.

Meanwhile, the company is planning a paediatric study for Lojuxta and is currently awaiting sign off for its study design from the EMA.

The company is also pursuing additional licences for AP101.

“We’re planning to study other severe partial thickness wound conditions, such as Toxic Epidermal Necrolysis (TENs) / Stevens Johnson Syndrome (SJS), a rare, serious disorder of skin and mucous membranes. These are being planned in parallel in order to maximise the potential value of the AP101 asset for Amryt, our shareholders and most importantly for patients.”

Plans to enter US market

As for expansion into the US, the company says it already has its first “boots on the ground” in the US and in Latin America, its teams there establishing the opportunities in the market and meeting with relevant stakeholders.

“The EB market is particularly appealing in the US – there are approximately 20 centres focusing on EB, therefore it makes it easier for a small, agile company like Amryt Pharma to work closely with them,” says Wiley.

“We can offer patients what they need as we seek to improve their quality of life, with more effective wound care.”

The design of the global trial for AP101 has already been agreed with the FDA, and the company is currently completing the pre-clinical package and preliminary safety data set the US regulator has requested in order to open the IND specific to the US.

Amryt won’t have the EB market to itself, however, and a number of companies are developing novel treatments for the condition.

These include US-based Fibrocell Science, which has just got the green light to begin phase 2 trials of its gene therapy candidate FCX-007 for recessive dystrophic epidermolysis bullosa (RDEB).

Another company in the field is Netherlands-based ProQR Therapeutics, which is working on an RNA-based therapy for dystrophic epidermolysis bullosa (DEB).

Interim analysis of the data from Amryt’s EASE trial will be available later in 2018, followed by top-line analysis.

The company expects to compile its submissions to the FDA and EMA shortly thereafter, with marketing authorisation in Europe and US anticipated late 2019, or possibly early 2020.


EMA accepts Marketing Authorisation Variation for Forxiga in adults with type-1 diabetes

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First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes.

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D. The short-term (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-relevant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses.

The safety profile of Forxiga in the DEPICT clinical programme to date is consistent with its established profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in dapagliflozin-treated patients versus placebo in these T1D studies. DKA is a known complication for patients with diabetes that affects those with T1D more frequently than with T2D.

Forxiga has the potential to become the first selective SGLT-2 inhibitor approved in Europe for the treatment of T1D as an oral treatment adjunct to insulin, helping to address a significant unmet need in this patient population. Forxiga is not currently licensed for use in T1D.

About the DEPICT Clinical Programme

The DEPICT clinical programme consists of two clinical trials, DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1 and DEPICT-2 are 24-week, randomised, double-blind, parallel-controlled trials designed to assess the effects of dapagliflozin 5 mg or 10 mg on glycaemic control in patients with T1D inadequately controlled by insulin. All patients will be evaluated at week 24 and after a 28-week extension (52 weeks in total).

About Forxiga (dapagliflozin)

Forxiga is a first-in-class selective inhibitor of human sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated as both monotherapies and as part of combination therapy to improve glycaemic control, with the added benefits of blood pressure reductions and weight loss in adult patients with type-2 diabetes (T2D).

AstraZeneca continues to push the boundaries of science with Forxiga through the largest and broadest, patient-centric clinical programme. The DapaCare clinical programme currently will enrol nearly 30,000 patients in randomised clinical trials, including a wide range of mechanistic studies, and is supported by a multinational real-world evidence study (CVD-REAL). DapaCare and complementary clinical research will generate first-in-class data for Forxiga across a spectrum of people with T2D, type-1 diabetes (T1D), established CV disease, CV risk factors and varying stages of renal disease, both with and without T2D, providing healthcare providers with the evidence needed to improve patient outcomes. DapaCare underscores our commitment to following the science with Forxiga, as the first SGLT-2 inhibitor to be studied in these diverse patient populations, pursuing a holistic patient approach to address the multiple risk factors associated with CV, metabolic and renal diseases.


Novo Nordisk delivers in much-anticipated oral semaglutide diabetes trial

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Novo Nordisk has lifted the curtain on much-anticipated results data from the first of ten Phase 3 trials into the efficacy of semaglutide when administered as a once-daily oral tablet in the treatment of type 2 diabetes in adults.

The study utilised two distinct criteria for assessing the drug’s efficacy, evaluating endpoints both taking into account and disregarding patient adherence to the medication. 703 participants were randomised to receive one of three doses of the drug: 3mg, 7mg or 14mg, while another group received placebo.

The findings reported that the trial met its primary endpoint, demonstrating “significant and superior improvements” in HbA1C(long-term blood sugar) compared to placebo in all three dose groups. These reductions, when patients adhered to treatment, were recorded as 0.8% in the 3mg group, 1.3% in the 7mg group, and 1.5mg in the 14mg group. In the same groups, 59%, 72% and 80% respectively achieved the American Diabetes Association target of below 7% HBA1C, compared to just 34% with placebo.

Additionally, the 14mg dose showed significant weight-loss benefits, recording reductions of 4.1kg compared to1.5kg with placebo.

“We are very encouraged by the results of the PIONEER 1 trial, which confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk. “We look forward to providing data from the remaining nine PIONEER trials throughout this year and an expected regulatory submission in 2019.”