Zydus Gains Approval for Phase II Clinical Study of NLRP3 Inhibitor 'ZYIL1' in ALS Patients

25 Oct 2023 , 10:44 AM

Zydus Life Sciences has gained approval from CDSCO, India, to initiate a Phase II clinical study of ‘ZYIL1,’ an NLRP3 inhibitor, in amyotrophic lateral sclerosis (ALS) patients. ALS is characterized by neuroinflammation and rapid neurodegeneration, leading to a loss of motor function.

ZYIL1 is an oral NLRP3 inhibitor with demonstrated potency in suppressing NLRP3 inflammasome-induced inflammation in pre-clinical studies. The drug has shown distribution in the brain and cerebrospinal fluid in various nonclinical species.

ZYIL1’s efficacy has been established in pre-clinical models of neuroinflammatory conditions such as Parkinson’s disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). Phase I studies confirmed its safety and tolerability. Zydus previously demonstrated a Phase 2 proof-of-concept for ZYIL1 in Cryopyrin Associated Periodic Syndrome (CAPS) and received an ‘Orphan Drug Designation’ from the USFDA for CAPS treatment.

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