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French biotech Abivax announced the shutdown, due to "a lack of efficacy", of the clinical study it had launched on its drug candidate for high-risk Covid-19 patients, in a published press release Friday night.

Abivax, following the recommendations of the trial monitoring committee (DSMB), decided to stop the phase 2b / 3 clinical trial of its product ABX464, which assessed its ability to "prevent progression to the severe form. disease ”in high risk patients.

A "safe and well tolerated" product

The DSMB recommendation is based on an interim analysis that assessed data on 305 patients who completed treatment.

In December, the drug candidate ABX464 in the treatment of the coronavirus had obtained the status of national research priority, which had then boosted the price of the title.

“Comparison of the data generated in patients treated with ABX464 versus the placebo group did not show any difference in the rate of progression to severe disease between the placebo group and the ABX464 group,” explains the Abivax press release.

The biotech adds that the study had established that the product was "safe and well tolerated" in patients.

"Although this result is disappointing, the positive safety data of ABX464 in these patients will be very useful for the next steps", commented Prof. Hartmut J. Ehrlich, CEO of Abivax, quoted in the press release.

The treatment received in May 2020 the green light from the French regulatory authorities (ANSM) to be tested against Covid-19, during a clinical trial called “miR-AGE” which included 1,034 patients.

The miR-AGE trial had already recruited 500 patients out of the 1,034 planned.

Abivax adds that the cessation of this clinical trial in the treatment of Covid-19 "has no impact on the development of ABX464 in chronic inflammatory diseases", with phase 2b results expected in the second quarter in two of these diseases.


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