Abivax has reported positive top-line data from the first cohort of Phase IIa ABX464-005 clinical trial of its drug candidate ABX464 in patients with HIV.

The results showed that ABX464 significantly decreased the HIV viral reservoir in blood, confirming the data obtained from the previous Phase IIa ABX464-004 trial.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Based on the firm’s anti-viral platform, ABX464 is being developed to inhibit the HIV replication through a new mechanism that involves modulation of RNA biogenesis.

The trial’s first cohort included 11 patients administered with 150mg ABX464 for 28 days, along with their anti-retroviral therapy.

Analysis has been performed on blood samples and rectal biopsies collected at pre-specified time intervals to quantify changes in the viral reservoir and mucosal inflammation over time.

Of the total participants, two were reported to have discontinued the trial because of grade 1/2 adverse events, while eight of the remaining nine subjects demonstrated reduced HIV DNA in peripheral blood CD4+ T cells between day zero and day 28.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The median decrease was found to be statistically significant, with patients showing a reduction from the initial 191 copies/million CD4+ T cells to 116 copies/million CD4 + T cells.

“In this first cohort, the rectal biopsies did not yield enough HIV DNA to make an assessment of the viral reservoir.”

Abivax chief medical officer Dr Jean-Marc Steens said: “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 for the generation of the appropriate data.”

The second cohort of the trial will involve evaluation of 50mg ABX464 over three months in 12 patients who are receiving their antiretroviral treatment.

It is expected that the initial results from this cohort will be available in the second quarter of next year.