Zydus Lifesciences Ltd’s shares were up 0.41 per cent after the company received approval from CDSCO, India, to commence Phase-II clinical trials of the NLRP3 inhibitor ‘ZYIL1’ for Amyotrophic Lateral Sclerosis (ALS) patients.

ALS leads to neuroinflammation and rapid neurodegeneration, resulting in the gradual loss of motor functions. It affects an estimated 31,000 individuals in the US, with approximately 5,000 new cases reported annually. Europe is home to over 30,000 ALS patients, and India has an estimated 75,000 individuals living with ALS. The median survival rate for ALS patients is approximately two years from diagnosis.

The Phase-II clinical trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in ALS patients. The trial’s primary endpoint is the change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score, measured at week 4, week 8, and week 12 in the placebo-controlled, randomised, double-blind trial. Key Secondary Endpoints will include Slow Vital Capacity (SVC) and neurofilament levels at week 4 and week 12, both of which are crucial indicators for functional loss in ALS.

ZYIL1, a novel oral small molecule NLRP3 inhibitor, has shown potency in suppressing inflammation caused by the NLRP3 inflammasome. According to the company, studies have also confirmed its distribution in the brain and cerebrospinal fluid in non-clinical species. Phase-I studies have established ZYIL1’s safety and tolerability.

Zydus has demonstrated Phase-2 proof-of-concept in CAPS (Cryopyrin Associated Periodic Syndrome) patients. ZYIL1 has received ‘Orphan Drug Designation’ from the USFDA for the rare auto-inflammatory disease.

The shares were up by 0.41 per cent at Rs 574 at 10.50 am on the BSE.

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