Zydus Lifesciences gets USFDA’s permission to initiate Phase II clinical study of ‘ZYIL1’ in patients with Parkinson’s disease

18 Dec 2023 Evaluate

Zydus Lifesciences has received permission from the United States Food and Drug Administration (USFDA), to initiate the Phase II clinical study of NLRP3 inhibitor ‘ZYIL1’ in patients with Parkinson’s disease. Parkinson’s is a devastating disease with patients steadily losing the control on movements leading to unintended or uncontrollable movements, such as shaking, stiffness and difficulty with balance and co-ordination. It is estimated that there are more than 8.5 million people in the world suffering from Parkinson’s disease, with 1 million 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 $52 billion every year, and by 2037 this disease is estimated to touch $80 billion every year.

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. 

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
 


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