Abivax S.A.S. (Euronext:ABVX) rose €10.50 (114%) to €19.70 after it said results of a Phase IIa study showed ABX464 reduced HIV reservoirs in chronically infected HIV patients.The small molecule inhibits viral replication by preventing rev-mediated export of unspliced HIV-1 mRNA transcripts to the cytoplasm.
The ABX464-004 study enrolled 30 chronically infected HIV patients in Spain, Belgium, and France. Abivax said seven of 14 evaluable patients had reductions of viral reservoirs at day 28, with a mean reduction of 40%, compared with no responders among four evaluable patients receiving placebo. The study measured total HIV DNA detected in peripheral blood mononuclear cells (PBMCs), a validated biomarker of viral reservoir load.
Abivax CMO Jean-Marc Steens told BioCentury the study's patients had controlled infection with undetectable viral load for six months prior to trial start. Patients received 50 or 150 mg oral ABX464 once daily in combination with antiretrovirals for 28 days, at which time all treatment was interrupted and blood samples were taken to compare viral reservoir with baseline measurements. Abivax also said ABX464 was well-tolerated, with no severe adverse events in the treatment group.
Steens said the 28-day treatment period was not sufficient to prevent viral rebound. In future testing, Abivax plans to extend treatment duration in the hopes of sufficiently reducing the HIV reservoir to prevent viral rebound. In the ongoing Phase IIa ABX464-005 study of ABX464, the company intends to amend the protocol to include a second cohort in which patients are treated for 56 or 84 days. That trial, whose first cohort has been enrolling patients since March, is studying the candidate's effects on the HIV reservoir in gut tissues. Initial results are expected in 3Q17.
Abivax hopes to begin a Phase IIb study of ABX464 by YE17. The company has also studied the molecule in preclinical tests to treat inflammatory bowel disease (IBD).
Data from a previous Phase IIa trial in 66 treatment-naïve HIV patients showed once-daily oral ABX464 monotherapy for 14 days led to dose-dependent antiviral activity.
Abivax ended the day with a market cap of about €191 million ($208 million).
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