Cerenis reports CER-209 safe, tolerable in phase 1 study for NAFLD

Results of a phase 1 study of repeated and increasing doses of CER-209 in patients with a high risk for nonalcoholic fatty liver disease or nonalcoholic steatohepatitis showed a favorable safety and tolerance profile, according to a press release from Cerenis Therapeutics.

“Beyond the validation of the standard tolerance, safety and determination of the pharmacokinetic parameters, this Phase 1b study supports the therapeutic potential of the CER-209 drug candidate as a dose related fall in fasted HDL cholesterol levels was observed at 28 days,” Jean-Louis Dasseux, founder of Cerenis, said in the release.

CER-209 is a specific agonist of the P2Y13 receptor that does not interact with the P2Y12 receptor. According to Cerenis, CER-209 has demonstrated favorable metabolic effects in the liver and may offer a new mechanism to treat NAFLD and NASH.

During the study, patients with visceral obesity and those with dyslipidemia received 10 mg, 30 mg or 60 mg of CER-209 compared with a placebo control group over a 28-day period. The investigators observed that CER-209 was absorbed within 30 minutes proportional to the administered dose.

“The next step consists of developing a formulation and assessing CER-209’s NASH efficacy endpoints within the framework of a phase 2 study of longer duration,” Dasseux said in the release.

Reference: www.cerenis.com