Mankind Pharma gets CDSCO panel nod for trial of anti diabetic molecule, MKP10241
New Delhi: Approving the Investigational New Drug (IND) application for Novel Anti Diabetic Molecule, MKP10241, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted permission to Mankind Research Center to conduct the Phase I Clinical trial of the molecule. However, the permission comes with certain conditions.
Mankind Research Center, presented the preclinical data along with the Phase I Clinical trial protocol for the said drug before the committee at the 13th SEC meeting to examine IND proposals, held on 11.06.2021 at CDSCO .
Earlier this year, the Medical Dialogues Team had reported that Mankind Pharma had submitted its first Investigational New Drug (IND) application for approval to the Indian Drug Regulatory Authority, Central Drugs Standard Control Organisation (CDSCO) for MKP10241, a patented first in class Novel Anti Diabetic Molecule.
MKP10241 is a potent and orally administered small molecule, G protein-coupled receptor 119 agonist (GPR119 agonist).
The G protein-coupled receptor 119 (GPR119) has gotten a lot of attention from the pharmaceutical industry in recent years since it's gradually becoming a prominent therapeutic target for treating Type 2 Diabetes Mellitus (T2DM), and its agonists may therefore represent potential new insulin secretagogues free of the risk of causing hypoglycemia.
GPR 119 is highly expressed in pancreatic beta cells and intestinal enteroendocrine cells. GPR119 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 of GPR119 in mediating glucose-dependent insulin secretion is distinct from the currently available therapeutic options for Type 2 diabetes and thus has become a promising new approach for the treatment of type 2 diabetes and related metabolic disorders.
It is also reported that the new drug MKP10241, a protein-coupled receptor 119 agonist (GPR119 agonist), was tested in multiple preclinical models of Type 2 diabetes to understand the mechanism of action and efficacy, and showed effective results in reducing blood sugar levels and glycated hemoglobin.
MKP10241 elevates plasma insulin as well as plasma GLP-1 levels, ultimately leading to reduced plasma glucose in preclinical models and validating the dual mechanism of action associated with GPR119. MKP10241 has already been granted patents worldwide till 2037.
Accordingly, at the 13th SEC meeting, the CDSCO panel evaluated the preclinical data as well as the Phase I Clinical trial protocol for MKP10241, which was presented by Mankind Research Center's proposal.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase I Clinical trial in the first three cohorts with 50mg, 100mg and 200mg doses, subject to the following conditions:
1. The 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 DSMB data to CDSCO.