Paris, April 27th, 2016 - ABIVAX (Euronext Paris: FR0012333284 - ABVX), an emerging leader in developing and commercializing anti-viral therapies and therapeutic vaccines for infectious diseases like HIV/AIDS and chronic hepatitis B (CHB), today announced that its abstract entitled, “Antiviral activity and safety of ABX464 in HIV-infected treatment-naïve patients” has been selected for presentation at the 21st International AIDS Conference (AIDS 2016) to be held in Durban, South Africa, 18-22 July 2016. The date and time of the presentation will be communicated in the coming weeks.
Prof. Hartmut J. Ehrlich, M.D, CEO of ABIVAX said, “We are delighted that our abstract has been accepted for presentation at the AIDS 2016 conference, considered the premier gathering for professionals working in the field of HIV. The acceptance to this important conference of ABIVAX’s abstract on the work we are doing with ABX464 signals the interest in and validation of our research and its findings by scientists and other constituencies working to address the unmet needs of HIV patients.”
ABX464 is an orally available small molecule therapeutic candidate that is currently in mid-stage clinical testing in HIV-patients. It works by inhibiting HIV replication through a novel mechanism (i.e. the modulation of RNA splicing) that may not be vulnerable to the development of resistance by the HIV virus, and may have a sustained effect in patients.
The first Phase IIa study with ABX464, the results of which were presented at CROI (the Conference on Retroviruses and Opportunistic Infections) in Boston in February 2016, and which are included in the subject matter of the abstract to be presented at the AIDS 2016 conference, showed the following results for ABX464 used in monotherapy: 1) a dose-related response, with 4 out of 6 patients in the highest dose group (150mg) achieving 0.5 log10 reduction by day 14. This dose-related antiviral response correlates with the pharmacokinetic properties of ABX 464. The CMax observed in the different cohorts showed a linear increase, correlated to the dose administered; and 2) a good safety and tolerability profile, with no serious and/or severe adverse events. The only adverse effects noted were mild to moderate in nature, and occurred shortly after dosing, which again correlates with the pharmacokinetic properties of the drug.
Dr. Robert Murphy M.D., Director of the Center for Global Health at Northwestern University in Chicago stated, “We are very encouraged by the initial results of the first Phase IIa study with ABX464, which demonstrate a clear dose-dependent effect on reducing the viral load in HIV patients.” Dr. Murphy continued, “We look forward to further study results from this novel drug candidate, which presents the potential to become a possible functional cure for HIV.”
Dr. Jean-Marc Steens, M.D., ABIVAX’s Chief Medical Officer said, “We believe we have achieved an important milestone with ABX464 in establishing a relationship between the dose of the drug administered, and the drop in the viral load of the majority of patients receiving the highest dose in our study.” Dr. Steens added, “We believe that these findings warrant the further development of ABX464, and have thus decided to proceed with a second Phase IIa study.”
A second Phase IIa study with ABX464, whose endpoint is to evaluate the long-lasting effect of ABX464 in reducing the viral load of infected patients who are controlled by “boosted” Darunavir, is currently being launched in Spain, and is also expected to be conducted in Belgium and France once the required authorizations are obtained. In addition to the Phase IIa clinical trials, large-scale clinical studies are expected to begin by early 2017.
ABIVAX (www.ABIVAX.com) is an emerging global leader in the discovery, development and commercialization of anti-viral therapeutics and therapeutic vaccines to treat some of the world’s most life-threatening infectious diseases, including HIV/AIDS and chronic Hepatitis B. ABIVAX has 2 compounds in clinical stage research: ABX464 a novel first-in-class resistance-proof oral small molecule HIV/AIDS therapy; and, ABX203, a therapeutic vaccine recently approved in Cuba and in late-stage clinical development in other countries that could cure chronic Hepatitis B. ABIVAX also is advancing additional anti-viral compounds and therapeutic vaccines that may enter the clinical stage in the coming 18 months. A recently updated corporate presentation, which includes a timeline for the company’s anticipated news flow, is available at www.abivax.com.
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