Zydus Lifesciences Limited, a leading discovery-based, global pharmaceutical company, has received permission from USFDA, to initiate the Phase II clinical study of NLRP3 inhibitor "ZYIL1" in patients with Parkinson's disease.

It is estimated that there are more than 8.5 mn people in the world suffering from Parkinson's disease, with 1 mn suffering from the disease in the US. Each year 90,000 new cases of Parkinson's disease are reported in the US. Analysts estimate that the treatment costs of Parkinson's disease amounts to almost US $52 billion every year, and by 2037 this disease is estimated to touch US $80 billion every year.

Speaking on the development, Pankaj R. Patel, Chairman, Zydus Lifesciences Ltd. said, "Our researchers have been working on path-breaking discoveries that can unlock new possibilities and help patients lead healthier and fulfilled lives. Our team is developing a novel, disease modifying approach through inhibiting the activation of NLRP3 inflammasome with ZYIL1, which could potentially reduce neuroinflammation and neuro-degeneration in patients suffering from Parkinson's disease."

ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation.

ZYIL1 was found distributed in the brain & CSF of various nonclinical species including mice, rats and non-human primates. The efficacy of ZYIL1 has been established in a number of validated pre-clinical models of neuro-inflammation and Parkinson's disease.

ZYIL1, has demonstrated desirable ADME profile, with good safety margin. In phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers. The Phase 2 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Parkinson's disease.