The French biotech said that its lead therapeutic candidate demonstrated the first reduction in HIV reservoirs ever observed in chronically infected HIV patients. Following the news, the company’s share price more than doubled.
It is the first evidence of treatment-induced reduction in HIV reservoirs ever, Abivax claimed in early May citing clinical data from its lead therapeutic candidate ABX464. Currently, approved HIV drugs can effectively reduce and control the replication of the HI virus in humans, allowing many patients to live with chronic treatment. Now there could be a drug on the horizon that is even able to eradicate the virus from the human body. Abivax targets the immune system to eliminate viral diseases using its proprietary technology platform. ”This is the first time we see a signal with any therapeutic candidate that it may be possible to reduce HIV reservoirs in patients,” said Professor Linos Vandekerckhove, Head HIV Cure Research Center at the Department of Internal Medicine, at the University of Ghent, Belgium, a principal investigator involved in the study. ‘’Now we are looking forward to learn how this drug can be optimized to be part of a multitarget approach to further reduce the viral reservoir.”
Abivax’ share price was around 7 euro before the news became public. Afterwards it skyrocketed to around 22 Euro.
In the ABX464-004 trial, 30 HIV patients were enrolled in Spain, Belgium and France. Patients were enrolled in a 3:1 randomization, receiving either ABX464 or matching placebo in addition to their current antiretroviral treatment during 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken in order to assess the potential effect of ABX464 on the HIV reservoir in peripheral blood mononuclear cells (PBMC).
The safety profile of ABX464 was good. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%), and no responders were observed in the placebo group. Total HIV DNA in PBMCs is considered a reliable biomarker for measuring the HIV reservoir.
“Based on this first ever clinical evidence that HIV reservoirs can be impacted in patients, we embrace the deep responsibility we have towards all HIV patients and the HIV community in driving this unique compound forward as rapidly as possible,” said Prof. Hartmut Ehrlich, CEO of Abivax.
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