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ALS, formerly known as Lou Gehrig's disease, is a neurological disorder that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing. ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent in human whole blood assay and can suppress inflammation caused by the NLRP3 inflammasome.
The phase 2 clinical trial will assess the safety and efficacy of ZYIL1 in Amyotrophic Lateral Sclerosis (ALS) patients. ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset.
Phase II clinical trial will study safety, tolerability, pharmacokinetics and pharmacodynamics in patients with ALS. The change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score will be measured at week 4, week 8 and week 12, as the trial's primary endpoint is the placebo-controlled, randomised, double-blind Phase 2 clinical trial.
The trial will also evaluate Key Secondary Endpoints including Slow Vital Capacity (SVC), a predictor of functional loss in ALS and neurofilament levels at week 4 and week 12.
Pankaj R. Patel, chairman, Zydus Lifesciences, said, “Zydus has always aimed at improving the quality of life of patients through its life changing discoveries. This study is a positive step in this direction to address very high unmet medical needs of patients suffering with ALS. By targeting neuroinflammation and neurodegeneration with ZYIL1, we hope to open up new possibilities in treating ALS.”
Zydus Lifesciences (Zydus Lifesciences) formerly Cadila Healthcare, is an integrated global healthcare provider. It discovers, develops, manufactures and commercializes various healthcare products.
The Pharmaceuticals company reported consolidated net profit jumped 109.7% to Rs 1,086.90 crore in Q1 FY24 as rise in net sales 28.8% to Rs 5,052.80 crore in same quarter.
The scrip rose 0.39% to Rs 572.65 on the BSE.
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