Category Archives: Clinical Trials

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.”


Summit Therapeutics to expand clinical trials after healthy interim results

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Summit Therapeutics will expand enrollment in its phase 2 clinical trials studying the effect of ezutromid treatment on Duchenne muscular dystrophy (DMD), the company said on Wednesday.

The PhaseOut DMD trial is a multi-centre, 48 week open-label clinical trial with 40 enrolled patients between the ages of five and ten who suffer from DMD which will be enhanced by the newly announced parallel running expansion.

David Roblin, chief operating and medical officer of Summit, said: “We are extremely grateful to the patients who participated in our Phase 1 clinical trials and contributed to ezutromid’s clinical advancement, but were not initially eligible to participate in our Phase 2 clinical trial. Accordingly, we are pleased to open this additional group in our Phase 2 and provide these patients with the opportunity to receive ezutromid treatment.”

Patients with DMD will be eligible for the expanded trial regardless of their age or ambulatory status.

DMD is a muscle wasting disease that affects approximately 50,000 men and boys in the developed world and is caused by genetic faults in the gene that codes dystrophin and thus preventing the healthy function of all muscles.

The orally administered small molecule drug is intended to modulate utrophin, a protein functionally and structurally similar to dystrophin, with the aim of slowing or even halting DMD.

Recently announced 24 week interim data from the trials demonstrated that compared to baseline, ezutromid significantly reduced muscle damage and muscle inflammation attributed to the disease.

“We expect the data collected from this additional group of patients will help expand our understanding of ezutromid’s safety and efficacy profile across a broader patient population,” said Roblin.

Ezutromid has been granted Fast Track designation and Rare Pediatric Disease designation by the US Food and Drug Administration (FDA) as well as orphan drug status which allows for additional regulatory support and a period of market exclusivity following approval.


Slow-release injectable gel boosts toxicity of cancer-fighting immunotherapy drugs

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An immunotherapy drug embedded in a slow-release hydrogel invented at Rice University in collaboration with the University of Texas Health Science Center at Houston (UTHealth) appears to be highly effective at killing cancer cells.

STINGel combines a new class of immunotherapy drugs called stimulator of interferon gene (STING) agonists with an injectable hydrogel that releases the drug in a steady dose to activate the immune system to kill cancer cells. It was developed by the Rice lab of chemist and bioengineer Jeffrey Hartgerink and Rice alum Simon Young, an assistant professor of oral and maxillofacial surgery at UTHealth.

In clinical trials, immunotherapy drugs have demonstrated strong cancer-fighting abilities. Research has also found that the drugs are flushed quickly from the body, and current trials require multiple injections.

The new research, which is detailed in Biomaterials, showed that slow-release peptide gels could continuously deliver immunotherapy drugs to tumor sites for long periods of time.

Hartgerink is a pioneer in the development of self-assembling multidomain peptide (MDP) hydrogels, which mimic the body’s extracellular matrix to encourage the growth of cells and vascular systems for tissue repair. The hydrogel is injected as a liquid, turns semisolid inside the body and slowly degrades over time.

The hydrogel in the new study is also welcoming to cells, but when the invaders are cancer cells, they’re in for trouble. Immunotherapy drugs known as cyclic dinucleotides (CDNs) await them inside the gel.

Hartgerink, a professor of chemistry and bioengineering, said the concentration of CDN in the hydrogel is important.

“The normal approach to CDN delivery is simple injection, but this leads to very rapid diffusion of the drug throughout the body and reduces its concentration at the site of the tumor to very low levels,” he said. “Using the same amount of CDN, the STINGel approach allows the concentration of CDN near the tumor to remain much higher for long periods of time.”

STINGel was studied both in lab cultures and in vivo. For the in vivo portion, six groups of 10 rodents each were treated with CDN alone, control collagens alone or with CDN, MDP alone or STINGel (CDN plus MDP). Only one in 10 CDN or collagen plus CDN animals survived 105 days, but six of 10 animals treated with STINGel survived. These also proved resistant to further implantation of cancer cells, meaning their immune systems were trained to successfully identify and destroy both the existing cancer and future occurrence of that cancer, Hartgerink said.

The lab tested more common hydrogels but found that they were unable to provide the same controlled release and also failed to provide an additional benefit over CDN treatment seen in clinical trials. “The MDP hydrogel provides a unique environment for the release of CDN that other gels just can’t match,” Hartgerink said.

“The CDN we used in this study is currently in clinical trials,” he said. “We think that our STINGel approach has the potential to significantly broaden the scope of this powerful immunotherapy drug to a larger range of resistant cancers.”


Magnetic nanoparticles prevent internal bleeding

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Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin.

Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin. A drug based on these nanoparticles can be injected intravenously and delivered straight to the site of a vascular injury. It can accelerate local clot formation and reduce overall blood loss by 15 times. The nanoparticles are not toxic to humans and can potentially be used for safe treatment.

In a new study, scientists from ITMO University suggested using magnet-driven nanoparticles to solve this problem. The particles consist of two key components. The first is thrombin, an enzyme responsible for blood clotting. It interacts with the protein called fibrinogen and triggers clot formation in order to block the damaged vessel. The thrombin is wrapped into a special porous matrix made of magnetite. This mineral is the second main ingredient and allows for precise control of the movement of particles inside the body using an external magnetic field.

Magnetic nanoparticles with thrombin have low activity and do not cause blood clotting if they are evenly distributed in blood vessels. Therefore it is possible to inject a solution of particles intravenously and localise them where needed using a magnet. When the patient receives an extra portion of fibrinogen, thrombin particles around the site of injury interact with it and the bleeding stops faster.

“We tested the nanoparticles’ efficiency on human blood plasma samples and a special vessel model,” says Andrey Drozdov, member of SCAMT Laboratory at ITMO University. “After the first experiments with plasma, we found out that thrombin in our nanoparticles is less active compared to its free variant. Yet we went on with the tests and ran additional experiments on a model of the bloodstream. We were able to observe how nanoparticles behave when the vessel is damaged. It turned out that magnetic localisation compensates for lower activity. Nanoparticles reduce the clotting time by 6.5 times and can reduce total blood loss by 15 times.”

“Synthesising these nanoparticles is not easy,” said the head of the laboratory Vladimir Vinogradov. “It is important to keep their size down to 200 nanometers; otherwise they will not be suitable for injection. In addition, mild synthesis conditions are required so that the thrombin molecule does not break down and lose its activity completely. Finally, we could only use biocompatible components. We checked the toxicity of our particles with human cells and made sure they are completely safe even during prolonged exposure.”

This work is part of a larger project aiming to create hybrid nanomaterial-based hemostatic drugs. Scientists are currently planning to test the drug based on the obtained material on animal models and, in case of success, run clinical trials. Researchers hope to create a nanoparticle-based hemostasis system that will be able to quickly and efficiently stop internal bleeding.

The results were published in Scientific Reports.


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.


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.


Blood test could predict response to breast cancer drug early

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A new study has found that a blood test for cancer DNA could predict if a woman is responding to the new breast cancer drug palbociclib, months earlier than current tests.

Scientists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, say the test could detect in two to three weeks whether the drug is working, although they caution that the results need replicating before they are used clinically.

The research, published today in the journal Nature Communications, was largely funded by the Medical Research Council (MRC). The researchers tested women with oestrogen receptor positive breast cancer – the most common kind – who were taking part in a clinical trial of palbociclib for advanced breast cancer.

In November 2017, palbociclib was approved for use on the NHS by NICE for women with previously untreated advanced breast cancer.

Currently, women must wait two to three months to find out if palbociclib is working, via a scan.

The new blood test instead looks for circulating tumour DNA – fragments of DNA shed by the cancer that have entered the bloodstream. The DNA mutations associated with the cancer can be detected in these samples.

The researchers found that they could predict if the palbociclib treatment would work by comparing the amount of a gene PIK3CA detected in a blood test before treatment and 15 days after starting treatment. In the study, 73 women had the PIK3CA mutation and were given blood tests before and after starting palbociclib treatment.

In these women, the researchers found that those who had a small decrease in PIK3CA circulating DNA at 15 days had a median progression-free survival (the length of time the patient survived and the cancer did not get worse) of only 4.1 months, compared to women with a large decrease in PIK3CA, who had a median progression-free survival of 11.2 months.

The test could allow the women in the first group for whom the treatment is not as effective to be identified early, so that they could consider altering their treatment.

Professor Nicholas Turner, senior author and Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Palbociclib is one of a new class of drugs that delays cancer progression for patients with advanced breast cancer, but it’s not effective for everybody. The problem is we have to wait for two to three months before doing a scan to see if the therapy is working.

“Our new study found that a blood test for cancer DNA in the first two weeks of treatment indicated whether the drug was likely to be effective. Having an early indication of how likely a treatment is to work might allow us to adapt treatment – switching some patients to an alternative drug that is more likely to benefit them.”

Dr Nathan Richardson, Head of Molecular and Cellular Medicine at the MRC, said: “This study provides early evidence that might help us understand sooner when a drug is successfully treating breast cancer, and if not, it can be discontinued and better approaches pursued.”

The research also received funding from the charity Breast Cancer Now and the pharmaceutical company Pfizer.


Migraine maven Lilly finds ‘understanding gap’ between patients, nonpatients in new survey

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Disconnects still exist in perceptions around migraines.

Surveying both migraine sufferers and average consumers, Eli Lilly found significant understanding gaps between the two.

For instance, migraine patients estimated their pain episodes lasted an average of 31 hours, while nonsufferers guessed the average fell around 21 hours. Migraine patients also rated the pain they felt much higher than the average person’s rating of what they imagined the pain to be.

“There is a huge stigma in migraine,” said Sheena Aurora, a physician who has treated migraine patients and is now a medical fellow at Eli Lilly. “… Sometimes even people with migraines don’t realize the impact of their disease. When I treated patients with migraines, I would ask them how many migraine headache days did they have, and they would have to stop and think about it.”

Lilly undertook the survey to determine migraine perceptions among three groups of people: migraine sufferers, caregivers and loved ones, and consumers who didn’t know anyone who suffers from migraines.

Other poll findings included that migraine patients feel stressed and that they’re missing out on life. Patients reported that migraines had prevented them from doing what they wanted in their lives for an average 7 days out of the previous 30 days.

During the previous year, the migraines had been severe enough to force them to miss an average of 7.4 important events, such as birthday or holiday gatherings. And an overwhelming majority—82%—agreed that it is stressful to have an unpredictable disease like migraine.

“By highlighting their unmet needs and continuing to do that, then we can help patients talk to their physicians, help physicians recognize their impact and perhaps even help payers understand the impact of migraines,” Aurora said.

She noted that the survey and other studies around migraines are important as new treatments created specifically for migraines come to market. Of the four currently FDA-approved drugs, none were designed exclusively for migraines, a fact that is often seen in low adherence when patients can’t take the side effects or don’t get enough relief, Aurora said.

Lilly is currently working to bring a new class of migraine therapy to market. The Indianapolis drugmaker has already filed a Biologics License Application with the FDA for its CGRP inhibitor maintenance drug galcanezumab, which is eventually expected to go up against contenders from companies including Amgen and Teva.

Meanwhile, Lilly’s first-in-class acute migraine candidate lasmiditan is in late-stage trials with expectations for FDA filings this year.


Gilead takes ‘HIV eradication’ combo into clinic

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Gilead has become a victim of its own success in hepatitis C, as it has pioneered a series of blockbuster combination drugs that are eradicating the disease, but are depleting the revenue-creating pool of infected patients.

Faced with pressure from competitors such as Merck & Co in hepatitis C, the company is now turning back to its old stomping ground – HIV, for which it has developed an arsenal of drugs that can stay the disease’s progression into full-blown AIDS.

Unlike hepatitis C, HIV is currently incurable, as drugs from Gilead and competitors like GlaxoSmithKline and Pfizer can only suppress it so that infected people can live much longer lives than in the past.

HIV creates a latent reserve within a patient’s body, lying dormant within infected CD4 cells, which can become activated and lead to the disease progressing into AIDS.

Only by tackling this reserve of infected, but dormant, T-cells can the disease be cured – and scientists have been trying for years to find ways to do this.

Gilead thinks it may have found a solution to the complex problem of tackling the infected dormant T-cells so that patients can control the disease without need for drugs.

Data from a trial in rhesus monkeys infected with simian-human immunodeficiency virus (SHIV) show that an oral toll-like receptor 7 (TLR7) agonist antiviral drug, and a broadly neutralising antibody (bNAb) could be an effective HIV eradication strategy for tackling this latent reserve.

Data from a subset of SHIV infected monkeys on suppressive antiretroviral therapy (ART) demonstrated a combination of a TLR7 called GS-9620, and a bNAb called PGT121, resulted in viral suppression after ART therapy stopped.

In the proof-of-concept study, 45% – five out out of 11 – of animals receiving both GS-9620 and PGT121 did not demonstrate viral rebound for at least 168 days after stopping ART. The other six animals rebounded but then began re-suppressing the virus without ART.

The data published at the Conference on Retroviruses and Opportunistic Infections showed that in a placebo arm 11 out 11 animals rebounded, nine out of 11 treated with only PGT121 rebounded and 10 out of 11 treated with GS-9620 rebounded.

Gilead is calling the combination therapy an “HIV eradication strategy” and will test it in phase 1 trials, in people who are HIV suppressed on approved ART therapies.

Gilead’s chief scientific officer, Norbert Bischofberger, said: “GS-9620 is currently in a phase 1b dose-escalation study in ART-suppressed people living with HIV and we have advanced GS-9722, a derivative of PGT121, into phase 1 testing.”

Gilead licensed in PGT121 from Theraclone Sciences under an agreement signed in 2014, although details of the deal were not disclosed at the time.

It was part of a portfolio of broadly neutralising antibodies discovered in collaboration with the International AIDS Vaccine Initiative and The Scripps Research Institute, Florida.