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Abivax’s COVID-19 study declared Research National Priority by French government

Drug treatment is being investigated in high-risk COVID-19 patients

Abivax’s COVID-19 study evaluating its anti-inflammatory candidate ABX464 has been deemed a ‘research national priority’ by a French government steering committee.

The steering committee for therapeutic clinical trials and other research (CAPNET) was created by the French government to identify promising and impactful COVID-19 clinical trials.

Those clinical trials, including Abivax’s study, that are declared to be a national priority gain access to an accelerated regulatory review and approval process by the French regulatory authorities (ASNM) and ethics committee (CPP).

“We are proud to be part of the national and international efforts to fight COVID-19 and that the French government's COVID-19 scientific council decided to designate the miR-AGE trial with ABX464 drug candidate a research national priority, given ABX464 promising characteristics for early treatment of infected patients,” said Philippe Pouletty, chairman of the board of Abivax.

“Abivax is devoting significant efforts to this major international clinical trial and simultaneously accelerating ABX464 manufacturing scale-up for potential 2021 commercialisation,” he added.

In July, Abivax treated the first patient in the phase 2b/3 miR-AGE study of ABX464 in COVID-19 patients.

The study, which is being conducted at the University Hospital Center in Nice, France, is investigating the effect of early treatment with ABX464 in 1,034 elderly or high-risk patients with confirmed COVID-19.

Currently, over 700 patients have been treated with ABX464, showing a good safety and tolerability profile.

Abivax’s main goal is to measure the potential of the experimental treatment to limit viral replication as well as decrease the severe inflammation that leads to acute respiratory distress syndrome (ARDS) in COVID-19 patients.

ABX464 has previously demonstrated efficacy in a phase 2a trial in the severe inflammatory disease ulcerative colitis (UC), in which the drug produced potent anti-inflammatory effects and tissue healing.

The drug’s efficacy in UC patients, coupled with its ‘unique molecular mechanism of action’, supports Abivax’s theory that the drug can help to treat cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients.

Results from the ongoing study are expected in the second quarter of 2021 – if positive, Abivax said that it will ‘immediately’ seek accelerated marketing approvals.

The French biotech added that it is already preparing for manufacturing scale-up and potential commercialisation of the anti-inflammatory treatment.

“Despite the recent approvals of COVID-19 vaccines, there are still many unknowns, and effective treatments for COVID-19 infection are needed more than ever,” said Hartmut Ehrlich, chief executive officer of Abivax.

“In addition to the logistical challenges of vaccinating billions of people, vaccines are currently not mandatory and public acceptance of vaccination may take time. So effective treatment options for infected patients are highly desirable,” he added.

Article by
Lucy Parsons

23rd December 2020

From: Research

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