Abivax’s HIV Cure Candidate Presents Positive Phase 2a – Virus
Paris-based biotech, Abivax has now announced top-line results from the first cohort of Phase 2a trial, ABX464-005, demonstrating that ABX464 significantly reduced the HIV viral reservoir in blood in patients with HIV.
Ian McGowan, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh School of Medicine and co-author of the study protocol, said: “This new data from the ABX464-005 study is very exciting and suggests that ABX464 could play a critical role in a HIV cure or eradication strategies.”
“ABIVAX reported data from the first cohort after treatment for 28 days. The second cohort, in which patients will be treated for three months, recently started recruiting patients and will begin to report data next year. The longer-term data will provide a better understanding of the potential for ABX464 to definitively induce a sustained viral remission.”
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, 11 patients with HIV infection received 150 mg ABX464 for 28 days in addition to their antiretroviral treatment. Blood samples and rectal biopsies were collected at pre-specified time intervals, allowing quantification of changes in the viral reservoir and mucosal inflammation over time. Nine patients from the first cohort completed the study. Eight of these nine patients showed a decrease between day 0 and day 28 in HIV DNA in peripheral blood CD4+ T cells.
Abivax is happy with the results it has seen so far, but hopes for more data from the second cohort of patients to further support ABX464’s potential: “In this first cohort, the rectal biopsies did not yield enough HIV DNA to make an assessment of the viral reservoir. For the ongoing second cohort, we have made changes to the procedures to ensure that enough high quality viral DNA is available…” Dr Jean-Marc Steens, Chief Medical Officer of Abivax explained.
AbiVax’s CEO, professor Hartmut Ehrlich, said the Paris-based company plans to expand clinical development following the results. Ehrlich said: “The new findings of the ABVX-005 study affirm our commitment and deepen the responsibility we have towards all HIV patients and the HIV community in driving this unique compound forward as rapidly as possible.”
