Celon Pharma Files for Approval of Phase II Trial of CPL'280, a Second Generation GPR40 Agonist, in Type 2 Diabetes

KIELPIN, Poland, June 22, 2021 (GLOBE NEWSWIRE) -- Celon Pharma today announced filing for approval to start a Phase II clinical study of CPL'280, its second generation GPR40 agonist in type 2 diabetes.

This double-blind, randomized, placebo-controlled, multiple dose Phase II study will evaluate the ability of orally administered CPL'280 to control blood glucose in patients with diagnosed type 2 diabetes. Both naive and metformin-inadequate responders will be administered once-daily CPL'280 for two weeks. Safety and pharmacokinetics will be secondary endpoints.

The trial plans to include 80 patients. Celon Pharma expects to dose the first patient in Q4 2021 and top-line results are anticipated in 1H 2022.

CPL'280 was designed to improve on the drawbacks of the first generation GPR40 agonists. The molecule, which is structurally different from the first generation agonists, is free from known risk factors associated with liver injury, i.e. bile acid transporter inhibition and the formation of reactive metabolites. The molecule showed strong evidence of safety both in preclinical and Phase I clinical studies including liver safety. Liver injury was a known risk factor identified for fasiglifam, which was the most advanced first generation GPR40 agonist which was terminated in late-stage clinical development.

Maciej Wieczorek, PhD, Celon Pharma CEO, commented: "We are looking forward to advancing this Phase 2 trial with CPL'280, which has shown significant potential to improve the current standard of care in diabetes. Our molecule has completed a preclinical program showing robust efficacy in multiple diabetic animal models and has also demonstrated efficacy beyond better glycemic control in diabetic neuropathy animal models. Diabetic neuropathy, which is one of the most common long-term complications of type 2 diabetes, is planned to be the second indication in the clinical development of CPL'280."

About Celon Pharma

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. 500 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.

More information can be obtained by contacting:

Małgorzata Siewierska

media@celonpharma.com