Celon Pharma Files for Approval of Phase II Trial of CPL’280, a Second Generation GPR40 Agonist, in Type 2 Diabetes
June 22, 2021 at 12:45 pm EDT
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Celon Pharma 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 Fourth Quarter 2021 and top-line results are anticipated in first half of 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.
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.