PRESS RELEASE : Abivax follows DSMB recommendation to stop the phase 2b/3 miR-AGE Covid-19 clinical trial due to lack of efficacy

DGAP-News: ABIVAX / Key word(s): Study 
Abivax follows DSMB recommendation to stop the phase 2b/3 miR-AGE Covid-19 clinical trial due to lack of efficacy 
2021-03-05 / 20:00 
The issuer is solely responsible for the content of this announcement. 
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Abivax follows DSMB recommendation to stop the phase 2b/3 miR-AGE Covid-19 clinical trial due to lack of efficacy 
The Data Safety and Monitoring Board (DSMB) confirmed ABX464 was safe and well tolerated in 383 high-risk Covid-19 
patients 
Lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX464 and 
placebo groups 
Decision has no impact on ABX464 development in chronic inflammatory indications 
ABX464 top-line clinical data expected in Q2 2021 for phase 2b ulcerative colitis trial and phase 2a rheumatoid 
arthritis trial 
PARIS, March 5, 2021 - 08:00 p.m. (CET) - 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." 
Prof. Jorge Kalil, M.D., Ph.D., Professor and Head of Clinical Immunology and Allergy at the University Hospital Center 
in São Paulo and national coordinator of the miR-AGE study in Brazil, added: "As an immunologist, I am puzzled by the 
outcome of the interim analysis, as ABX464 addresses both the viral and inflammatory aspects of the disease. However, 
we recognize that Covid-19 is a novel, hyper-acute and complex disease that involves various viral and inflammatory 
pathways, plus the coagulation system, which are still not fully understood. The participation of clinical research 
teams across Brazil within this multinational trial was a very enriching experience that will be valuable for future 
clinical studies." 
Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: "The miR-AGE trial was set up based on a scientifically sound 
rationale and it was robustly designed with the input of a highly experienced steering committee in order to evaluate 
the safety and efficacy of ABX464 in preventing severe Covid-19 disease and death in high-risk patients. Although this 
is a disappointing outcome, the good safety and tolerability data in this fragile population will be very useful going 
forward, and I would like to thank all investigators, healthcare personnel, patients and Bpifrance for their active 
involvement in the study. ABX464 has been shown to be highly efficacious in treating "chronic" inflammation according 
to clinical, endoscopic and histological endpoints in ulcerative colitis, as confirmed by the phase 2a data published 
this week in the peer-reviewed "Gastroenterology" article. Therefore, this outcome in "hyper-acute" Covid-19 disease 
has no impact on ABX464 potential to be successful in chronic inflammatory disease." 
About Abivax (www.abivax.com) 
Abivax, a clinical stage biotechnology company, is modulating the body's natural immune machinery to treat patients 
with chronic inflammatory diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (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. Follow us on Twitter @ABIVAX_. 
Contacts 
Abivax                  Investors                      Press Relations & Investors Europe 
Communications          LifeSci Advisors               MC Services AG 
Regina Jehle            Chris Maggos                   Anne Hennecke 
[e-mail] [e-mail]      [e-mail] 
[phone]       [phone]                [phone] 
Public Relations France Public Relations France        Public Relations USA 
Actifin                 DGM Conseil                    Rooney Partners LLC 
Ghislaine Gasparetto    Thomas Roborel de Climens      Marion Janic 
[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. -----------------------------------------------------------------------------------------------------------------------

2021-03-05 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. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de -----------------------------------------------------------------------------------------------------------------------

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March 05, 2021 14:02 ET (19:02 GMT)