Posted Jan 17, 2023, 10:51 AM
A real hope for patients with sepsis at high risk of acute kidney injury. The Toulouse biotech Abionyx Pharma, formerly Cerenis Therapeutics, has just announced that the phase 2a pilot clinical trial evaluating CER-001, the only natural recombinant apoA-I, has reached the primary and secondary endpoints. To date, there is no approved treatment for septic patients anywhere in the world where the disease caused 13.7 million deaths worldwide in 2019 recalls Professor Loreto Gesualdo, Head of the Nephrology, Dialysis and Transplantation Unit at the University of Bari and principal investigator of the Racers study. This focused on a cohort of 20 patients suffering from Gram-negative bacterial sepsis and at high risk of acute kidney injury, due to high endotoxin activity and functional decline of one or more organs. Patients received either standard therapy alone or in combination with one of three CER-001 dosing regimens.
The primary focus was on the onset and severity of acute renal failure, as well as the safety and tolerability of different regimens to determine the optimal dose of CER-001 to prescribe. The trial was conclusive: the administration of the molecule had an effect direct and meaningful » on the elimination of endotoxins and the reduction of the cytokine cascade (inflammatory reaction), as well as a protective effect on endothelial function. It shows a tendency toreduction in the number of intensive care days for treated patients, the reduction in the need for organ replacement and the improvement of 30-day survival », Specifies Abionyx Pharma in its press release. These results are consistent with those obtained in another indication, Covid-19.
TP Icap Midcap vise 10 euros
Studies in the indication of sepsis will continue in Europe and the United States, and could, as for phase IIa, be carried out in partnership. ” We are thus confirmed in our scenario: next clinical steps in 2023-2024, regulatory authorizations in 2025 and marketing in 2026. », Writes this morning the analyst of the firm TP Icap Midcap. It also renews its estimate of the value of CER-001 in the sepsis indication at 1.1 billion euros. ” 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 “, he concludes. Despite a jump of 16% this morning, the title Abionyx Pharma remains well below this objective for the moment since it is trading at 2.24 euros.
