Search This Blog

Friday, March 5, 2021

Abivax stops phase 2b/3 miR-AGE Covid-19 trial due to lack of efficacy

 Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company modulating the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that it is halting the miR-AGE phase 2b/3 clinical trial in high-risk Covid-19 patients after the independent Data Safety and Monitoring Board (DSMB) recommendation for lack of efficacy.

The multinational miR-AGE ABX464 phase 2b/3 clinical trial (ABX464-401), has already recruited 500 high-risk Covid-19 patients out of the planned 1,034 and has been declared "Research National Priority" by the French government in December 2020. The study has a robust randomized, double-blind and placebo-controlled design to test whether ABX464 could prevent the development of severe Covid-19 disease in the participants. The DSMB recommendation is based on a planned, interim analysis evaluating data of 305 high-risk Covid-19 patients who completed the study period. The comparison of the data generated in the patient group treated with ABX464 versus the placebo group, did not show a difference in the rate of severe disease between the placebo group and the ABX464 group. Importantly, ABX464 was well tolerated and safe in these high-risk Covid-19 patients.

Eric Cua, M.D., infectious disease specialist at the University Hospital Center (CHU) of Nice and principal coordinator of the miR-AGE trial in France, said: The very well designed and conducted miR-AGE study aimed at preventing severe acute disease characterized by hyperinflammation and cytokine storm. Thanks to the robust study design, we can rely on the outcome of the interim analysis that showed the futility of the trial. The analysis also confirms the good safety of ABX464. The low rate of severe disease in this high-risk population was unexpected, however, it is good news about the prognosis of high risk Covid-19 patients with the current standard of care and with emerging variants."

https://www.pharmiweb.com/press-release/2021-03-05/abivax-follows-dsmb-recommendation-to-stop-the-phase-2b3-mir-age-covid-19-clinical-trial-due-to-lac

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.