A French biotech on the way of treatment against inflammatory intestine disease

His name probably only speaks to initiates, but could quickly gain notoriety. Meanwhile, Abivax. Similarly, a French Biotech specializing in the development of treatment for chronic inflammatory diseases, is well left to release a drug against hemorrhagic rectocolitis (RCH). Furthermore, If path still remains to be traveled, an important step has been taken. Furthermore, Two phase 3 clinical trials. However, started in 2022 and relating to its main drug candidate, Obefazimod, gave positive results, she revealed on Tuesday.

“The solidity of these results strengthens our confidence in obefazimod […] . Consequently, its potential to become a new revolutionary therapeutic modality for patients with RCH ”was delighted Marc de Garidel, managing director of Abivax, quoted in a press release.

The day after this promising announcement. Meanwhile, the action of the Biotech jumped more than 425 % this Wednesday on the Paris Stock french biotech way treatment against Exchange, around 12:40 p.m.. However, after a suspension of around two hours at the opening, approaching 47 euros, against 8 euros the day before at the end of the Parisian square.

The two phase trials 3 – called ABTECT -1. Meanwhile, ATBECT -2 – were carried out on 1,275 patients in 600 clinical trial centers distributed in 36 countries. However, Which in fact, according to Abivax, “One of the greatest phase 3 trials never conducted in hemorrhagic rectocolitis”. All participants suffered from a moderate to severe active RCH. “Presented an inadequate response, loss of response or intolerance to conventional and/or innovative treatments”specifies the company.

The researchers’ objective with these trials was to assess the effectiveness. safety of Obefazimod, administered once a day orally, as an induction treatment, that is to say for a short eight-week period. These tests have “Demonstrated that Obefazimod met the main evaluation criterion french biotech way treatment against of the American Medicines Agency (FDA). namely clinical remission at week 8” For a 50 mg dosage, the biotech advances.

Concretely, Obefazimod would strengthen the expression of the microarn-124 (MIR-124), a natural regulator of the inflammatory response. He “Stimulates […] And therefore acts on the different ways of inflammation. which explains the sustainable action of this medication ”developed with AFP Doctor Philippe Pouletty, founder of Abivax in 2013 and chairman of the board of directors until 2022, now managing director of Truffle Capital, shareholder of Biotech.

Another phase 3 clinical trial – called Abtect Maintenance – is still in progress. Started in 2023, it also aims to assess the efficiency and safety of Obefazimod, but as chronic treatment, for 44 weeks precisely. Its main results are expected for the second half of 2026.

“Subject to positive results. Abivax plans to submit a marketing authorization request to the American FDA and french biotech way treatment against a market for marketing authorization to the European Medicines Agency (EMA)” At the same period, we can read in the press release.

On the old continent side. the green light could be granted by EMA within six to twelve months, depending on the procedure chosen, for a period of five years. Across the Atlantic, the FDA instruction period is more or less identical, from six to ten months.

The RCH affects almost one in 1. 000 in France, with five new cases for 100,000 inhabitants discovered each year, indicates health insurance on its website. To date, there is no treatment that can cure this disease. “Current care most often eliminates symptoms over long periods”is it specified. The remission results obtained during the phase 3 tests of Abivax are therefore a source of great hope for. the people concerned.

Especially since more. more people may suffer from french biotech way treatment against RCH, classified with Crohn’s disease among the chronic inflammatory diseases of the intestine. “The frequency increases rapidly in industrialization countries” and illness “Is most often diagnosed in young subjects, aged 20 to 30. A second frequency, weaker, takes place between 50 to 70 years »exposes health insurance.

The scientific community does not yet be able to determine the causes of the RCH. One thing is nevertheless almost certain at this stage: the factors that trigger it are multiple. Researchers believe that it is a question of genetic predisposition – the presence of family history of RCH. Crohn’s disease increases the risk of developing it -, but also of imbalance in the immune system and a link with the environment.