Celon Pharma Announces CPL’280, Second Generation Oral GPR40 Agonist, Meets Primary Endpoint in Phase 1 Trial
April 01, 2021 at 03:30 am EDT
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Celon Pharma S.A. 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. 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.
Celon Pharma SA is a Poland-based company primarily engaged in the pharmaceuticals manufacture. The Company focuses on research, development and production of generic drugs for cancer, neurological diseases, diabetes and other metabolic disorders treatment, among others. Its products portfolio comprises pills, such as Aromek, Bosentan Celon, Donepex, Ketrel, Lazivir and Valzek, as well as inhalation powder, such as Salmex. The Company's research center develops pharmaceuticals within a number of therapeutic areas, including oncology, neurology, as well as inflammatory and metabolic diseases. The Company is a subsidiary of Glatton sp z o o.