Celon Pharma Announces CPL'280, Second Generation Oral GPR40 Agonist, Meets Primary Endpoint in Phase 1 Trial
KIELPIN, Poland, April 01, 2021 (GLOBE NEWSWIRE) -- Celon Pharma S.A. today announced the successful completion of a Phase 1 trial of its second generation GPR40 agonist, CPL’280. This agent is in development for the treatment of Diabetes and Diabetic Neuropathy and met its primary endpoint, with no adverse safety signals detected.
“We are very pleased with the results from this Phase 1 trial, demonstrating that CPL’280 is safe and well tolerated,” said Maciej Wieczorek, PhD, Celon Pharma's Chief Executive Officer and Head of Research & Development. “CPL’280 is part of a deep innovative pipeline of proprietary programs that strive to improve upon limitations identified in first-generation molecules. Based on these data, Celon Pharma plans to initiate Phase 2 proof-of-concept studies with CPL’280 in Type 2 Diabetes and Diabetic Neuropathy in the coming months and has submitted data on CPL’280 for publication.”
In the trial, CPL’280 was administered orally in single and multiple ascending doses in healthy volunteers to assess safety and pharmacokinetic parameters (PK). Pharmacokinetic interactions with metformin and food were also tested. No adverse events associated with administration of CPL’280 were observed, the primary endpoint of the trial.
No alanine aminotransferase (ALT), aspartate transaminase (AST) or any other liver toxicity measures were elevated in the study which is particularly critical as first generation GPR40 agonists were previously terminated in late-stage development due to liver toxicity risks. Pharmacokinetics were linear and no interactions with food or metformin were noted.
CPL’280 is structurally different from first generation molecules and is designed to improve on the liver toxicity signal identified in earlier programs. The molecule showed robust efficacy in animal diabetic models. It is also the first GPR40 agonist which demonstrated efficacy in diabetic neuropathy animal models after oral administration.
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