FIRST PATIENT DOSED IN THREE-MONTH COHORT OF PHASE 2A STUDY OF ORAL ABX464 IN HIV-SUPPRESSED PATIENTS

September 18, 2017
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Trial Will Evaluate Effects of ABX464 on HIV reservoirs in gut tissue and blood 
Study measures response rate over time

PARIS, Sept. 18th, 2017 at 8 a.m. CEST – ABIVAX (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral diseases using its unique antiviral technology platform, today announced that the first patient has been dosed in the second cohort of the Phase 2a ABX464-005 clinical trial. ABX464-005 is a Phase 2a trial studying the effects of ABX464 on HIV reservoirs and on inflammation in blood and in gastrointestinal tissue.

ABX464 is a first-in-class oral, small molecule anti-viral drug-candidate discovered by ABIVAX.  It inhibits HIV replication through a unique mechanism of action and also has a strong anti-inflammatory effect as demonstrated in preclinical testing.  Specifically, ABX464 inhibits the activity of REV, a key HIV protein, thereby promoting HIV RNA splicing and thus inhibiting HIV replication through a novel mechanism (i.e., the modulation of RNA splicing) that may not lead to the development of resistance.

In the first cohort, 12 patients with HIV infection received 150mg of ABX464 for 28 days in addition to their antiretroviral treatment. Rectal biopsies were collected at pre-specified intervals to quantify the change in viral load and level of inflammation in those HIV reservoirs over time. Initial results of the first cohort are expected in the first week of October.

The second cohort of 12 patients will receive 50mg of ABX464 for three months in addition to their antiretroviral treatment. Similar to the first cohort, patients will undergo rectal biopsies at pre-specified intervals to quantify the change in viral load and level of inflammation over the three-month time period. The first patient of the second cohort was dosed at the Germans Trias i Pujol University Hospital Badalona in Barcelona, Spain. Initial results of the second cohort are expected in the second quarter of 2018.

Jean-Marc Steens, M.D., chief medical officer of ABIVAX, commented: “The second cohort will give us important information on the ability of ABX464 to further reduce the HIV reservoirs and improve the response rate over a longer time period. We are grateful to the Barcelona center of excellence and their patients for their continued support in further developing this molecule targeting the HIV reservoir, potentially leading towards a functional cure.”