Mankind Pharma Receives CDSCO Nod for Phase 1 Trials of Novel Autoimmune Drug Candidate
Mumbai: Mankind Pharma Ltd., India’s 4th largest pharmaceutical company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to initiate a Phase 1 clinical trial of MKP11093, a novel, orally administered Janus kinase-1 (JAK-1) inhibitor. The molecule is being developed for the treatment of multiple autoimmune disorders, including rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia.
Promising Preclinical Results
Developed at the Mankind Research Centre, MKP11093 has shown strong results in preclinical studies with a promising safety and selectivity profile. The molecule works by targeting JAK-1, disrupting the JAK/STAT signaling pathway, and reducing the activity of several pro-inflammatory cytokines. This makes it a unique treatment candidate with the potential to deliver better outcomes in autoimmune diseases.
Phase 1 Trial and Future Prospects
The Phase 1 trial is expected to begin shortly and will evaluate the safety, tolerability, and pharmacokinetics of MKP11093 in healthy volunteers through single and multiple-ascending dose studies. According to Arjun Juneja, Chief Operating Officer, Mankind Pharma, the development of MKP11093 represents the company’s endeavour to deliver a best-in-class JAK inhibitor that maximises therapeutic potential while addressing safety concerns.
