Mankind Pharma Gets CDSCO Nod for JAK-1 Inhibitor Trial

Mankind Pharma, India's fourth largest pharma company, has received approval from CDSCO to conduct a phase 1 clinical trial for its new JAK-1 inhibitor, MKP11093.

The orally available drug molecule, which has been developed at Mankind Research Centre, will be developed for treatment of a number of autoimmune diseases including but not limited to: rheumatoid arthritis, ulcerative colitis, plaque psoriasis, and alopecia.

In pre-clinical studies, MKP11093 demonstrated a strong safety and selectivity profile which places it among the promising candidates in the crowded JAK inhibitor space. The drug molecule targets Janus kinase-1 (JAK-1 ), a key enzymes in the JAK family which also consists of JAK2, JAK3, and TYK2. The JAK/STAT signalling pathway is important for activating pro-inflammatory cytokines and inhibiting the activity of this axis may improve treatment options for patients with autoimmune diseases.

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Arjun Juneja, chief operating officer, Mankind Pharma, said: “The development of MKP11093 is a major milestone in this effort, representing our endeavour to deliver a best-in-class JAK inhibitor…with a strong focus on ensuring that such innovations are accessible and affordable to those who need them most, both in India and globally.”

The upcoming phase 1 trial will determine if MKP11093 is safe, tolerable, and assess its pharmacokinetics in healthy volunteers with single and multiple-ascending dose studies. Since inception in 2012, the Mankind Research Centre has been championing discovery programmes in autoimmune diseases, metabolic diseases like diabetes, obesity, and NASH, and oncology. MKP10241 another pipeline candidate, has already completed phase 1 studies and is now in phase 2 development for obesity and diabetes, demonstrating the growing range of innovation contributing to Mankind Pharma's position in the pharmaceutical industry.