Celon Pharma Announces CPL’280, Second Generation Oral GPR40 Agonist, Meets Primary Endpoint in Phase 1 Trial

KIELPIN, Poland I April 01, 2021 I 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.

Celon Pharma is an integrated biopharmaceutical company which designs, develops, manufactures and distributes pharmaceutical products. It was founded in 2002 by Maciej Wieczorek, PhD. The Company currently has approx. 450 employees. It employs approx. 160 scientists responsible for research and development, half of whom either have a PhD or are in the process of acquiring their PhD. The Company's pipeline includes more than a dozen projects for the development of innovative drugs with therapeutic groups such as oncology, neuro-psychiatry, autoimmunity and metabolism. The Company has its own research and development laboratories, which allow it to develop its own pharmaceutical technologies by using extensive laboratory equipment resources, as well as the experience and expertise of its staff. It also has a modern manufacturing facility where dry pharmaceutical forms are manufactured. Over the last few years, the Company has introduced products into the market in the following therapeutic areas: oncology, central nervous system diseases, cardiology, HIV treatment, respiratory diseases. The Company has been developing the technology for manufacturing inhalation drugs and several projects of innovative drugs since 2007. It has been listed on the Warsaw Stock Exchange since 2016. www.celonpharma.com

SOURCE: Celon Pharma

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