US FDA approves first rapid diagnostic test for Ebola: October’s industry headlines

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Take a look at this month’s industry headlines including US FDA approvals for XOFLUZATM and a rapid diagnostic test for Ebola, new trials for the antibiotics zoliflodacin and gepotidacin, and grants for cannabinoid company Botanix Pharmaceuticals.

 GARDP and Entasis Therapeutics initiate Phase III trial of zoliflodacin, a first-in-class antibiotic for gonorrhea

The Global Antibiotic Research and Development Partnership (GARDP; Geneva, Switzerland) and Entasis Therapeutics (MA, USA) have announced the initiation of a global Phase III trial for zoliflodacin – a novel, first-in-class, oral antibiotic for the treatment of uncomplicated gonorrhea.

The announcement follows positive Phase II results, with the Phase III study aiming to enroll 1000 adults with urogenital gonorrhea from sites in the USA, Thailand, South Africa and the Netherlands. Data is expected in 2021.

Discover more about GARDP in our interview with Director of Business Development & Corporate Strategy Jean-Pierre Paccaud >

Manica Balasegaram, Executive Director of GARDP, commented: “The initiation of the Phase III trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhea and controlling this infection. The global nature of the trial, across four continents, represents our commitment to ensuring this treatment is available to anyone who needs it, wherever they live.”
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Japan’s Global Health Innovative Technology Fund grants £1 million to saliva-based malaria diagnostic

Japan’s Global Health Innovative Technology (GHIT) Fund has awarded a grant of £1 million to facilitate the production, testing and validation of a saliva-based rapid diagnostic test for malaria.

The funding was secured by the University of Florida (FL, USA) and will be used for final product development and commercialization of this diagnostic by start-up Erada Technology Alliance (Ebene, Mauritius). The diagnostic, which is based on a new Plasmodium falciparum protein biomarker (pssp17) in saliva, is to be marketed around the world under the brand name ‘SALVA!’ with the aim of launching in 2021. Field trials are being rolled out in 2020 in the Democratic Republic of Congo.

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US FDA approves Descovy for HIV pre-exposure prophylaxis

The US FDA has approved Gilead Science’s (CA, USA) Descovy (emtricitabine/tenofovir alafenamide) for HIV pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing >35kg. This is the second drug to be authorized for PrEP, following Truvuda in 2012.

The approval was based on data from the DISCOVER trial, a Phase II study evaluating the safety and efficacy of Descovy in over 5300 cis-gender adult men who have sex with men, or transgender women who have sex with men. Gilead CEO Daniel O’Day remarked: “Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time.”

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BiondVax receives €4M to support ongoing universal influenza vaccine Phase III trial

BiondVax Pharmaceuticals Ltd. (Ness Ziona, Israel) has received €4 million from the European Investment Bank in support of the ongoing testing of its universal influenza candidate, M-001. These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.

Learn more about the strategy for approving a universal flu vaccine and M-001 in this article from Future Virology >

The safety and efficacy of M-001 is currently being assessed in a Phase III trial enrolling 12,000 adults aged 50 years or above. Overall 4094 individuals enrolled in the trial’s first cohort in the 2018–19 season, and approximately 8000 participants are hoped to enroll in the 2019–20 cohort. Results are expected by the end of 2020.

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Arbutus Biopharma discontinues development of AB-506 for hepatitis B

Arbutus Biopharma (Burnaby, Canada) has announced the discontinuation of development for its investigational oral capsid inhibitor AB-506, which was in Phase Ia/b trials for the treatment of chronic hepatitis B.

Preliminary results for this study were announced in July 2019, demonstrating that the therapy was associated with mean reduction in hepatitis B DNA and RNA levels after 28 days. However, two cases of acute hepatitis in occurred in the 28-day clinical trial in healthy volunteers.

Gaston Picchio, Chief Development Officer of Arbutus, explained: “The two subjects are experiencing resolution of their acute hepatitis. We will continue to follow them and the other study participants, as safety is our highest priority at Arbutus. We intend to present results from the AB-506 Phase 1a/1b clinical trial along with further details regarding the two cases of acute hepatitis at an appropriate scientific meeting later in 2019.”

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US FDA accepts applications for Merck’s DIFICID® for C. difficile infections in children

The US FDA has accepted a New Drug Application for DIFICID® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of C. difficile infections in children aged between 6 months and 18 years.

The sNDA is based on results from the Phase III SUNSHINE study. Nicholas Kartsonis, Senior Vice President, Clinical Research, Merck Research Laboratories, commented: “Evidence indicates the increasing incidence of C. difficile-associated diarrhea among hospitalized children. The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.”

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Discover more about the SUNSHINE study in our interview with Yoav Golan >

US FDA approves first rapid diagnostic test for Ebola

The US FDA has allowed for the marketing of a new rapid diagnostic test for Ebola, the OraQuick Ebola Rapid Antigen Test. The diagnostic provides a presumptive diagnosis from blood or cadaveric oral fluid that must be confirmed, the FDA stated.

The test was made available during the West Africa outbreak and subsequent outbreaks in the Democratic Republic of Congo via the FDA’s Emergency Use Authorization pathway, however, it has now been approved for sale in the USA.

“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the US Government, especially as we work with our partners, including the WHO, to help address the current Ebola outbreak in the Democratic Republic of Congo,” stated Acting FDA Commissioner Ned Sharpless.

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FDA approves XOFLUZATM for individuals at high risk of flu-related complications</>

The US FDA have approved an expanded indication for one-dose XOFLUZATM (baloxavir marboxil), allowing it to be used for the treatment of flu in those aged over 12 years who are at high risk of developing flu-related complications. This includes individuals with asthma, diabetes, lung disease, or adults aged 65 or older.

The approval was based on data from the Phase III CAPSTONE-2 study. XOFLUZA is now the first and only FDA-approved antiviral flu medicine specifically indicated for the high-risk population, it was first approved by the FDA in October 2018 for the treatment of uncomplicated flu in those over 12 years old.

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Cannabidiol company Botanix Pharmaceuticals receives Innovation Connections Grant

Clinical stage cannabidiol company Botanix Pharmaceuticals Ltd. (Sydney, Australia) has been awarded a new Innovation Connections Grant from the Australian Government to accelerate its program aiming to create new synthetic analogs of cannabidiol. The work is being carried out in partnership with Scientists from the University of Queensland (Brisbane, Australia).

Executive Director of Botanix, Michael Thurn, commented: “We are very pleased that this new program has been supported by AusIndustry through the Innovation Connections Grant program and we look forward to accelerating the development and testing of these novel cannabidiol analogs over the coming months.”

Learn more about the potential activity cannabidiol holds against Gram-positive bacteria >

“We are also pleased to continue our partnership with Mark Blaskovich’s team at The University of Queensland. Their extensive expertise in testing molecules, combined with their understanding of the mechanisms of antimicrobial resistance and state-of-the-art research facilities, will help facilitate the rapid advancement of these new drugs into clinical trials.”

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Algenex submits recombinant VLP vaccine to European Medicines Agency

Algenex (Madrid, Spain) had announced that an industry partner has submitted a recombinant VLP vaccine, produced using Algenex’s proprietary CrisBio® technology, to European Medicines Agency.

Claudia Jiménez, General Manager of Algenex, remarked: “CrisBio has the potential to transform recombinant protein production and this first submission to the EMA by one of our industry partners is a key milestone for Algenex. A potential approval would serve as regulatory validation and pave the way for future regulatory submissions for both vaccines and other biological products. We continue to work closely with our partners to deliver on our mission to be the partner of choice for the production and manufacture of protein-based products.”

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European Medicines Agency recommends conditional marketing authorization for Ebola vaccine

The European Medicines Agency has made an announcement recommending a conditional marketing authorization for Merck’s (NJ, USA) rVSV-ZEBOV-GP vaccine, which has been shown to be effective in protecting against the Ebola virus.

Discover the latest updates on the Democratic Republic of the Congo vaccine strategy >

The European Medicines Agency noted that results from studies involving around 16,000 individuals and compassionate use programs have shown that rVSV-ZEBOV-GP protects against Ebola virus disease in humans following a single-dose administration.

This announcement will not have an immediate effect on how the vaccine is accessed or administered in the Democratic Republic of the Congo, as licensing has not yet occurred, and licensed doses will only be available mid-2020. The vaccine will continue to be used in the country under a research protocol with the ring vaccination strategy.

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GlaxoSmithKline to sell travel vaccines to Bavarian Nordic

GlaxoSmithKline (Brentford, London) is set to divest two travel vaccines – Rabipur and Encepur – to Bavarian Nordic (Kvistgaard, Denmark) under a transaction potentially worth up to €955 million.

The rabies vaccine, Rabipur, and Encepur, which is used for the prevention of tick-borne encephalitis, were acquired by GlaxoSmithKline from Novartis (Basel, Switzerland) in 2015. Roger Connor, President of Global Vaccines at GlaxoSmithKline, commented that the transaction “will enable us to commit greater resources to our key growth assets and to our R&D pipeline.”

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PhagoMed expand pipeline by adding a recombinant phage enzyme targeting bacterial vaginosis

PhagoMed Biopharma GmbH (Vienna, Austria) is expanding its development pipeline by adding a recombinant phage enzyme (endolysin) that specifically targets bacterial vaginosis. Researchers at PhagoMed isolated these Gardnerella-specific phage lysins and have optimized them by genetic engineering. On this basis, PhagoMed has filed a patent application for this class of recombinant endolysins and has established a team to further develop this product.

PhagoMed’s co-founder and co-CEO, Dr. Lorenzo Corsini, concluded: “Phages and endolysins offer effective alternatives to antibiotics blunted by bacterial resistance, and they work very precisely without destroying the natural microbiome. What’s more, they can combat bacteria in impenetrable biofilms, where antibiotics are ineffective independently of resistances.”

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GlaxoSmithKline starts late-stage program for antibiotic gepotidacin

GlaxoSmithKline has announced that patient dosing has begun in its Phase III trials for the experimental triazaacenaphthylene topoisomerase inhibitor gepotidacin in patients with uncomplicated urinary tract infection and urogenital gonorrhea. This program consists of the EAGLE-1 and EAGLE-2 studies, with the first results expected at the end of 2021.

Understand more about the antibiotics introduced for gonorrhea and a timeline of when resistance was first identified in our infographic >

Hal Barron, Chief Scientific Officer and President of Research and Development at GSK commented: “Given the increasing rate of antibiotic drug resistance, and gepotidacin’s unique mechanism of action, we believe this drug has the potential to transform the treatment landscape for patients with uncomplicated urinary tract infection and urogenital gonorrhea who currently have limited therapeutic options.”

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BioVersys receives CARB-X award of up to US $8.92 million

BioVersys AG (Basel, Switzerland) has received US $3.94 million in non-dilutive funding from CARB-X, with the possibility of US $4.98 million more if certain project milestones are met. The funding will go towards the development of novel antimicrobial therapies, specifically the anti-virulence BV200 series, which are designed to target Staphylococcus aureus.

Marc Gitzinger, CEO and co-founder of BioVersys, stated: “We are delighted that CARB-X recognizes the immense potential of BioVersys’ anti-virulence program (BV200) through this funding award. The diversity in the challenge of antimicrobial resistant diseases, requires us to broaden our approach beyond classical antibiotics, and further R&D investment in novel paradigm shifting approaches such as anti-virulence is vitally important. BioVersys is committed to continue its development of novel targeted antimicrobials and deliver new treatment options to AMR patients worldwide.”

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Missed last month’s industry headlines? Catch up here >

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