PRESS RELEASE : Abivax's Covid-19 Phase 2b/3 miR-AGE trial with ABX464 declared Research National Priority by the French government's Clinical Trial Council

 
 DGAP-News: ABIVAX / Key word(s): Study 
Abivax's Covid-19 Phase 2b/3 miR-AGE trial with ABX464 declared Research National 
Priority by the French government's Clinical Trial Council 
 
2020-12-22 / 19:30 
The issuer is solely responsible for the content of this announcement. 
 
*Abivax's Covid-19 Phase 2b/3 miR-AGE trial with ABX464 declared Research National 
Priority by the French government's Clinical Trial Council* 
 
  · _Research National Priority has priority for patient enrollment in clinical 
  trials for an accelerated review and approval process with the French regulatory 
  authorities_ 
 
  · _Effective Covid-19 treatments very much needed because optimal vaccination 
  coverage of millions of individuals and public acceptance will take time_ 
 
  · _ABX464 mechanism of action not expected to be impacted by viral mutations_ 
 
  · _Pivotal phase 2b/3 Covid-19 trial results expected in Q2 2021 and ABX464 
  manufacturing scale-up is ongoing to meet potential demand from commercialization 
  in 2021_ 
 
*PARIS, December 22, 2020 - 7:30 p.m. (CET)* - Abivax (Euronext Paris: FR0012333284 
- ABVX), a clinical-stage biotechnology company harnessing the immune system to 
develop novel treatments for inflammatory diseases, viral diseases and cancer, 
today announced that the Company's ongoing ABX464 phase 2b/3 trial in high-risk 
Covid-19 patients (miR-AGE) has been declared a "Research National Priority" by the 
French government steering committee for therapeutic clinical trials and other 
research (CAPNET). This committee, advised by the REACTing Scientific Council, has 
been created by the French government to identify the most promising and impactful 
Covid-19 clinical trials in order to help investigators focus their patient 
recruitment and to foster the swift availability of high-level study results. 
Clinical trials declared Research National Priority and their sponsors have access 
to an accelerated regulatory review and approval process conducted by the French 
regulatory authorities (ANSM) and the French Ethics committee (CPP). The Research 
National Priority designation also incentivizes clinical investigators to 
prioritize enrollment of their patients in these clinical trials and may provide 
institutional financing of these clinical studies. 
 
*Philippe Pouletty, M.D., Chairman of the Board of Abivax and CEO of Truffle 
Capital, said: *_"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._ _Abivax is devoting significant efforts to this major 
international clinical trial and simultaneously accelerating ABX464 manufacturing 
scale-up for potential 2021 commercialization. The strong support of Bpifrance and 
GCI has been critical in providing the necessary resources to our team and 
partners._ _We cannot predict the efficacy of ABX464 in Covid-19 patients before 
miR-AGE trial results are available. However, given the major impact of Covid-19 
pandemic, it is our duty to anticipate the commercial availability of ABX464 in 
order to be ready to obtain a marketing authorization and launch the product in 
2021, should the miR-AGE trial provide positive results."_ 
 
Abivax's lead drug-candidate ABX464 has shown in clinical and preclinical studies 
that it may have a potentially beneficial triple effect for the treatment of 
elderly and high-risk Covid-19 patients, including an antiviral and 
anti-inflammatory effect as well as tissue repair properties. With its unique 
molecular mechanism of action (upregulation of miR124), and convenient oral dosing, 
ABX464 can be used in patients upon diagnosis and has the potential to prevent and 
treat cytokine storm and hyper-inflammation, which can lead to acute respiratory 
distress syndrome (ARDS) and death of Covid-19 patients. Should the results from 
the ongoing phase 2b/3 Covid-19 study expected for Q2 2021, be positive, Abivax 
will immediately seek accelerated marketing approvals in the major markets in 2021, 
and it is preparing for manufacturing scale-up and potential commercialization of 
ABX464. 
 
ABX464 is mainly developed to treat patients with chronic inflammatory diseases and 
is currently in clinical testing in a phase 2b study in ulcerative colitis (UC), a 
phase 2a study in rheumatoid arthritis (RA) and a pivotal phase 2b/3 trial in 
Crohn's disease will commence in 2021. Topline results of the ongoing trials in UC 
and RA are expected in Q2 2021. So far, over 700 patients have been treated with 
ABX464 showing a good safety and tolerability profile. Some patients have been on 
daily treatment with ABX464 for over three years in the ongoing phase 2a open label 
extensions study in UC, with promising long-term efficacy results after 2 years of 
continued treatment. The Company is currently preparing to move its clinical trial 
program with ABX464 in UC into a pivotal phase 3. 
 
*Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, added: *"Despite the recent 
approvals for Covid-19 vaccines, there are still many unknowns and effective 
treatments for Covid-19 infection are needed more than ever. In addition to the 
logistical challenges in 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. In addition, the 
duration of vaccine protection is still unknown and mutations may emerge - this 
means we still urgently need to decrease the likelihood of evolution towards severe 
life-threatening disease in Covid-19 infected patients. As miR-AGE is now a 
Research National Priority, we hope that the French study centers will be able to 
recruit more high-risk patients to catch up with other European and Latin American 
countries. These patients will then be able to potentially benefit from ABX464's 
triple effect, along with its convenient and easy oral administration, which also 
may avoid the need to be hospitalized and ease the burden on our healthcare 
systems." 
 
*About Abivax (www.abivax.com)* 
Abivax, a clinical stage biotechnology company, is mobilizing the body's natural 
immune machinery to treat patients with chronic inflammatory diseases, viral 
infections, and cancer. Abivax is listed on Euronext compartment C (ISIN: 
FR0012333284 - Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug 
candidates in clinical development, ABX464 to treat severe inflammatory diseases, 
and ABX196 to treat hepatocellular carcinoma. More information on the company is 
available at www.abivax.com [1]. Follow us on Twitter @ABIVAX_. 
 
*Contacts* 
 
*Abivax *               *Investors*                    *Press Relations & Investors 
*Communications*        *LifeSci Advisors*             Europe* 
Regina Jehle            Chris Maggos                   *MC Services AG* 
[e-mail] [e-mail]      Anne Hennecke 
[phone]       [phone]                [e-mail] 
                                                       [phone] 
*Public Relations       *Public Relations France*      *Public Relations USA * 
France*                 *DGM Conseil *                 *Rooney Partners LLC* 
*Actifin*               Thomas Roborel de Climens      Marion Janic 
Ghislaine Gasparetto    [e-mail] [e-mail] 
[e-mail]  [phone]              [phone] 
[phone] 
 
*DISCLAIMER* 
 
This press release contains forward-looking statements, forecasts and estimates 
(including patient recruitment) with respect to certain of the Company's programs. 
Although the Company believes that its forward-looking statements, forecasts and 
estimates are based on assumptions and assessments of known and unknown risks, 
uncertainties and other factors that have been deemed reasonable, such 
forward-looking statements, forecasts and estimates are subject to a number of 
risks and uncertainties that could cause actual results to differ materially from 
those anticipated in such forward-looking statements, forecasts and estimates. A 
description of these risks, contingencies and uncertainties can be found in the 
documents filed by the Company with the French Autorité des Marchés Financiers 
pursuant to its legal obligations including its registration document (Document 
d'Enregistrement Universel). Furthermore, these forward-looking statements, 
forecasts and estimates are only as of the date of this press release. Readers are 
cautioned not to place undue reliance on these forward-looking statements. Abivax 
disclaims any obligation to update these forward-looking statements, forecasts or 
estimates to reflect any subsequent changes that the Company becomes aware of, 
except as required by law. 
This press release is for information purposes only, and the information contained 
herein does not constitute either an offer to sell, or the solicitation of an offer 
to purchase or subscribe securities of the Company in any jurisdiction, in 
particular in France. Similarly, it does not give and should not be treated as 
giving investment advice. It has no connection with the investment objectives, 
financial situation or specific needs of any recipient. It should not be regarded 
by recipients as a substitute for exercise of their own judgement. All opinions 
expressed herein are subject to change without notice. The distribution of this 
document may be restricted by law in certain jurisdictions. Persons into whose 
possession this document comes are required to inform themselves about and to 
observe any such restrictions. 
 
2020-12-22 Dissemination of a Corporate News, transmitted by DGAP - a service of 
EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
 
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