Zydus Lifesciences Receives USFDA Approval for Phase II Study of ZYIL1

Ahmedabad: Zydus Lifesciences Limited, a discovery-based, global pharmaceutical company, has announced that it has received permission from USFDA to initiate the Phase II clinical study of NLRP3 inhibitor “ZYIL1” in patients with Parkinson’s disease.

About Parkinson’s Disease

Parkinson’s is a devastating disease with patients steadily losing control over movements, leading to unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. 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 amount to almost U.S. $52 billion every year, and by 2037 this disease is estimated to touch U.S. $80 billion every year.

Statement from Zydus Lifesciences

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 more 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.”

About ZYIL1

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 a desirable ADME profile, with a good safety margin. In phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers [NCT04731324, NCT04972188]. The Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Parkinson’s Disease.

Previous Studies and Designations

Previously, Zydus had demonstrated the efficacy of ZYIL1 in CAPS (Cryopyrin Associated Periodic Syndrome) patients [NCT05186051], and was the first to establish the phase 2 proof-of-concept with an oral small molecule NLRP3 inhibitor in CAPS patients. The phase-2 data of ZYIL1 in CAPS has now been published in “Clinical Pharmacology in Drug Development”.

Zydus has been granted an ‘Orphan Drug Designation’ by the US FDA for ZYIL1 in the treatment of patients with CAPS, a rare auto-inflammatory disease. Additionally, Zydus has also initiated a Phase 2 clinical trial of ZYIL1 in patients with Amyotrophic Lateral Sclerosis (ALS), a neurodegenerative disease.

Additional Information

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