(BFM Bourse) – The former Cerenis announced Monday positive results for the phase 2a study evaluating CER-001, to treat patients with sepsis at high risk of developing acute renal failure.
Biotech Abionyx takes an important step for the clinical development of its flagship molecule. The company, which was still called Cerenis until the summer of 2019, announced on Monday afternoon that its phase 2a RACERS study (intermediate stage of clinical trials, which evaluates the effectiveness of a drug) had reached all of its primary and secondary evaluation criteria.
This study evaluated the most important molecule of the group, CER-001, in the treatment of patients with sepsis at high risk of developing acute renal failure (ARI). RACERS thus focused on 20 patients suffering from Gram-negative bacterial sepsis and presenting a high risk of AKI due to high levels of endotoxin activity and a decline in the function of one or more organs.
Patients received 8 doses of CER-001 for 6 days in addition to standard therapy, or standard therapy alone.
A disease that has caused 13.7 million deaths worldwide
“In this pilot study, CER-001 was shown to directly decrease endotoxin and inhibit inflammation, thereby limiting the associated downward spiral often experienced by septic patients. (…) Primary and secondary endpoints were shown that CER-001 therapy was beneficial when added to standard treatments,” Connie Peyrottes, vice president responsible for clinical development at Abionyx, said in a statement.
“The positive results of this phase 2a trial show that CER-001 has the potential to be a game-changer for serious diseases marked by inflammation and organ failure in different high-mortality clinical indications that continue to need unsatisfied medical conditions,” she continued.
“The results allow […] to think that the CER-001 molecule could provide a solution for the treatment of sepsis (a disease which caused 13.7 million deaths worldwide in 2019), but also for other serious and acute inflammatory diseases”, emphasizes his TP side ICAP Midcap.
The financial intermediary says it is confirmed in its scenario for the molecule, namely regulatory authorization for this indication in 2025 and marketing in 2026.
“In view of the very positive results of the RACERS study, we are increasing the probability of success in the sepsis indication in our valuation approach, now retained at 25% compared to 5% before, leading to raising our price target on the value from 8 euros to 10.5 euros”, explains TP ICAP Midcap, who also reiterated his advice to buy.
On the Paris Stock Exchange, the market appreciates the decisive milestone reached by Abionyx. The action thus climbed 19% to 2.295 euros around 2:05 p.m.
Julien Marion – ©2023 BFM Bourse
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