Zydus Lifesciences advances Phase II Trial of ALS drug candidate ZYIL1

Zydus, a prominent global pharmaceutical enterprise, has gained approval from CDSCO, India, to commence Phase II clinical trials for their NLRP3 inhibitor, "ZYIL1," targeting Amyotrophic Lateral Sclerosis (ALS). ALS is a rare, relentless neurodegenerative ailment with an average life expectancy of 3 to 5 years post-symptom onset.

 

Mr. Pankaj R. Patel, Chairman of Zydus Lifesciences Ltd., expressed their commitment to enhancing patient quality of life through groundbreaking discoveries. The study endeavors to address the substantial unmet needs of ALS patients by targeting neuroinflammation and neurodegeneration with ZYIL1, potentially revolutionizing ALS treatment.

 

ALS inflicts rapid neurodegeneration and neuroinflammation, resulting in the progressive loss of motor functions, speech, and eventually, breathing. It leads to a decline in motor neurons in the brain and spinal cord, governing voluntary muscle actions.

 

Statistics from the CDC reveal approximately 31,000 ALS patients in the U.S., with 5,000 new diagnoses annually. Europe hosts over 30,000 cases, while India accounts for an estimated 75,000 individuals living with ALS.

 

The Phase II trial will scrutinize safety, tolerability, pharmacokinetics, and pharmacodynamics in ALS patients. The primary endpoint will measure the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score changes at week 4, 8, and 12 in the placebo-controlled, randomized, double-blind trial. Secondary endpoints will include assessments of Slow Vital Capacity (SVC) and neurofilament levels.

 

ZYIL1, an innovative oral small molecule NLRP3 inhibitor, exhibits potent anti-inflammatory properties, making it a promising candidate for ALS treatment. Pre-clinical models have demonstrated its effectiveness in neuroinflammatory conditions, Parkinson’s disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). Phase I studies affirmed ZYIL1's safety and tolerance, setting a positive foundation for its therapeutic potential.

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