Sanofi and Regeneron Pharmaceuticals are teaming up with the American College of Cardiology (ACC) to see if ACC can enhance their clinical research with alirocumab, an investigational monoclonal antibody that targets PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is an enzyme that contributes to circulating low-density lipoprotein cholesterol levels.
The ACC will, per the agreement, use its registries to identify patients who might be good candidates for the Phase III ODYSSEY OUTCOMES trial. This collaboration is the first time ACC's PINNACLE Registry will be used for trial recruitment. ACC says this recruitment program is a new approach to identification and recruitment of patients for clinical trials.
"The ACC's registries and related provider networks support quality improvement programs for practitioners," Ralph Brindis, past-president of the ACC and Senior Medical Officer of External Affairs for the National Cardiovascular Data Registries (NCDR), said in a statement. "For the first time, through our PINNACLE ambulatory office-based registry of the NCDR, we will be helping to solve the difficult problem of identifying physicians with patients who may be eligible for a clinical trial."
Sanofi and Regeneron forged a mAb discovery, development, and commercialization partnership back in November of 2007. Just last month, the firms received good news about a mAb candidate they co-developed for rheumatoid arthritis (RA) when they announced successful results of the first Phase III trial for sarilumab, which they describe as the first fully human mAb directed against the interleukin-6 receptor. The candidate, when used in combination with methotrexate (MTX) therapy, improved disease signs and symptoms as well as physical functions while also inhibiting progression of joint damage in adults with RA for whom MTX therapy alone didn't greatly improve their condition.