The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) has given its clearance to Mankind Pharma for conducting phase I clinical trial of MKP10241, a patented first in class novel anti-diabetic molecule.The approval came after the drug maker presented the preclinical data along with phase I study protocol for the drug before the committee at its 13th meeting held on June 11, 2021.After detailed deliberation, the committee recommended grant of permission to conduct the phase I clinical trial in first three cohorts with 50mg, 100mg and 200mg dose subject to the following conditions: 1) Thymus toxicity biomarker should be clearly defined and monitored during the clinical trial. 2) Thymus toxicity data at 28 days (repeated dose toxicity data) and at recovery stage should be submitted to CDSCO. 3) The firm should submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO.MKP10241, a new class of anti-diabetic molecules, is designed and developed at the Mankind Research Centre. It is a potent and orally administered small molecule, GPR119 agonist. GPR 119 is highly expressed in pancreatic beta cells and intestinal enteroendocrine cells. It elevates intracellular secondary messengers such as cAMP inside the cells and promotes postprandial insulin and incretin secretion (GLP-1) in a glucose-dependent manner.This dual mechanism by GPR119 in mediating glucose-dependent insulin secretion is distinct from the currently available therapeutic options for type 2 diabetes and thus becomes a promising new approach for the treatment of type 2 diabetes and related metabolic disorders.MKP10241 was tested in multiple preclinical models of type 2 diabetes and has shown efficacy in lowering blood sugar levels and glycated hemoglobin.The firm has received global patents for MKP10241 till 2037.The first in class drug will prove to be effective in reducing blood sugar levels and thus it will be of tremendous benefit to the people with diabetes, said RC Juneja, executive chairman, Mankind Pharma.
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