It is worth mentioning the importance of finding a drug that will treat the disease, with or without a vaccine, since the Brazilian population will not have access to the immunizer at the same time and this process can take years. ABX464 is manufactured by the French biotechnology company Abivax, and it is expected, with its use, to reduce the number of patients who need hospitalization and also the period spent in hospital – that is, a drastic decrease in severe forms of the disease.

The study’s communication and dissemination efforts are intended to spread this news to as many people as possible, so that they know they can participate in the tests (if they are eligible) and look for the nearest research center. The more people who participate in this initiative, the sooner there will be a conclusive result on ABX464, a potential drug to treat Covid-19 that has shown extremely positive results in the previous stages of testing, and we have a more peaceful future in relation to the disease.

French biotech company Abivax starts miR-AGE study in patients at risk for disease

• New drug under study ABX464 can reduce the serious effects of COVID-19 infection, reducing the number of participants who need hospitalization and the recovery time for hospitalized participants.
• ABX464 has a potential triple beneficial effect in the treatment of participants with COVID-19: antiviral, anti-inflammatory and tissue repair.
• Several clinical research centers in Brazil will participate in the study, with strict inclusion criteria for participants in a randomized, placebo-controlled study (miR-AGE study).
• Participants confirmed with COVID-19, over 65 or under 65 who have risk factors, will receive ABX464 orally for 28 days
• The miR-AGE study will include a total of 1034 participants in Europe and Latin America.

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Abivax SA (Euronext Paris: FR0012333284 – ABVX), a biotechnology company that conducts clinical trials, focused on the immune system to develop innovative treatments for inflammatory diseases, viruses and cancer, announces the beginning of  miR-AGE , a study for COVID- 19, in several clinical research centers in Brazil. The study was approved by ANVISA (Brazilian health agency), as well as by health agencies in France, Germany, United Kingdom and Italy. Approval by the authorities of Mexico, Chile and Peru is in progress.

“In the current situation, without vaccine and without mass immunity against COVID-19, we need a rapid treatment that reduces the severity of this disease“, says Prof. Hartmut Ehrlich, MD, CEO of Abivax.

According to Prof. Jorge Kalil, MD, Ph.D., professor of clinical immunology and allergy at the Faculty of Medicine of the University of São Paulo and coordinator of the miR-AGE study in Brazil, Abivax’s clinical research will assess whether early anti-inflammatory treatment with ABX464 can improve outcomes in COVID-19 ‘participants: “ABX464 is a compound in the final stage of development that presents a new mechanism of action in the treatment of participants with inflammatory diseases. Phase 2b / 3 studies test the potential of a new therapeutic candidate in preventing severe inflammation that leads to  Severe Acute Respiratory Syndrome  (SARS) in elderly or high-risk participants for COVID-19. The molecule has already  presented data on Transformational efficacy in participants with ulcerative colitis, also an inflammatory disease. In addition, ABX464 showed a favorable safety profile in more than 300 volunteer participants and those with HIV or ulcerative colitis.“

“Our mission is to develop drugs to improve and save the lives of patients’ and I am proud to be able to use Abivax research and its expertise in fighting the COVID-19 pandemic that is plaguing the world,” says Philippe Pouletty, MD, Chairman of the Board of Abivax.

This double-blind, randomized, placebo-controlled, phase 2b / 3 study will assess the potential benefits of the triple action of the drug under study ABX464 in 1,034 elderly or at-risk participants for COVID-19, which include:

1. Anti-inflammatory effect  to treat hypercitonemia and hyperinflammation syndrome observed in participants with COVID-19. This effect of ABX464 has already been demonstrated in a phase 2a study in another serious inflammatory disease, ulcerative colitis. Pulmonary hyperinflammation is the main cause of respiratory distress and death in patients with COVID-19.
2. Antiviral effect  to inhibit the replication of SARS-CoV-2 (COVID-19) which has been demonstrated in a rigorous model of human lung epithelium  in vitro .
3. Tissue repair properties  to prevent potential long-term lung dysfunction after infection. In participants with ulcerative colitis, ABX464 demonstrated a curative capacity for inflammatory lesions.

To date, more than 300 participants have been treated with ABX464, and the study drug has excellent clinical safety and tolerability profile.

• The convenient oral administration of ABX464 allows early treatment of hospitalized or non-hospitalized participants. Non-hospitalized participants will take an ABX464 capsule orally, once daily, for 28 days, at home. During the mandatory 14-day quarantine period, participants will receive treatment and will be monitored by phone. From the third week of treatment, or from the date on which the participant is released from quarantine by his doctor, the participants must attend the hospital, once a week, for monitoring.

The rigorous Phase 2b / 3 study will be conducted in accordance with international clinical research standards in Latin America and Europe. The study will include a robust participant selection procedure, randomization against placebo and monitoring, as well as management, data collection and statistical analysis. For more information about the miR-AGE clinical study visit  the website  or call or send a whatsapp message to 0800 454 54 54 (8 am to 5 pm).

Main points of the study:

• ABX464 oral dose (50 mg once daily) vs. placebo and standard treatment, 2 to 1 randomization.
• Inclusion of hospitalized and non-hospitalized participants, confirmed for SARS-CoV-2 infection.
• Main evaluation criteria: no use of high flow oxygen or assisted ventilation, or absence of death within 28 days.
• Multiple secondary clinical and biological parameters.
• Treatment duration (ABX464 or placebo and standard treatment): 28 days
• 50 hospitals in Europe and Latin America

Study inclusion criteria:

• Infection confirmed by SARS-CoV-2 (disease COVID-19)
• Participants over 65
• Adults under 65 who have risk factors (obesity, diabetes, hypertension, heart disease)

Mechanism of action of ABX464 in participants with COVID-19:

Philippe Pouletty, MD,  Chairman of the Board of Abivax and CEO of Truffle Capital, says:  “The miR-AGE study with ABX464 has been endorsed by leading experts in France, Europe, and the United States. We hope that ABX464, with unique antiviral, anti-inflammatory and tissue repair properties, and convenient oral administration, will prove to be a promising therapy for patients with COVID-19. It is worth remembering that the pathophysiology of COVID-19 is complex, therefore, we must be cautious about the potential success of the miR-AGE study.“ 

Prof. Hartmut Ehrlich, MD,  Abivax’s CEO, adds: “Unfortunately, to date, no therapeutic treatment or prophylaxis has proven effective in judicious studies to treat the severe form of COVID-19. This means that assisting physicians in preventing respiratory distress and death in patients with COVID-19 and limiting long-term lung damage is an overriding need. In addition, reducing the need to use ICUs in hospitals is a priority. ABX464 is a small molecule available in oral presentation that may have the potential to achieve some of these objectives due to its unique mechanism of action and ease of use. The robust and thoughtful design of the miR-AGE study for ABX464 ensures that we will arrive at important clinical and scientific conclusions and, if successful, we will work with health authorities to make ABX464 available as soon as possible. We already have ABX464 capsules in stock for the treatment of approximately 50,000 patients, and we can increase the production of ABX464 in a few months for the treatment of more than one million patients.”. 

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About Abivax 

Abivax, a biotechnology company that conducts clinical trials, is mobilizing the body’s natural immune mechanism to treat patients with autoimmune diseases, viral infections and cancer. Abivax is listed on Euronext B (ISIN: FR0012333284 – Mnémo: ABVX). Headquartered 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 about the company is available at  www.abivax.com . Follow us on Twitter @ABIVAX_

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