(AOF) – Abionyx Pharma announced that the last patient has been enrolled in the Phase 2a clinical study evaluating CER-001, Bio-HDL, as a potential treatment for patients with sepsis at high risk of developing kidney injury. acute. The biotech company reconfirms that final key results will be reported by late fall 2022.
Professor Loreto Gesualdo, Full Professor, Head of Nephrology, Dialysis and Transplantation Unit, University of Bari Aldo Moro, Italy, said: “Following the positive interim results already obtained in the RACERS clinical study, a randomized study comparing short-term infusions of CER-001 at different doses to prevent acute kidney injury induced by Sepsis, we were finally able to finalize the recruitment of patients.We are more determined than ever to contribute to the development of real options treatments in sepsis, and to fight against the mortality that affects this population of patients, more than 250,000 deaths being recorded each year in Europe and the United States.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: assessment of the overall benefit/risk ratio with several thousand patients.
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An inevitable race for new blockbusters
The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite the loss, since 2019, of the patents for its three star products (Avastin, Herceptine, Rituxan) Roche was able to renew its portfolio by bringing new molecules to market. However, the discovery and launch of new drugs are increasingly expensive. AstraZeneca spends about $6 billion a year on R&D in a pharmaceutical industry where the life of a patent only lasts ten to fifteen years. This leads laboratories to withdraw from certain activities. Thus J&J, Pfizer, GSK and, no doubt, Novartis soon prefer to refocus on specialty drugs and abandon any ancillary activity.