Zydus Lifesciences announced the completion of enrolment for its Phase II clinical trial of Usnoflast (ZYIL1), an oral NLRP3 inflammasome inhibitor, in patients with Amyotrophic Lateral Sclerosis (ALS). 

The company informed that ALS is a rare, progressive, and fatal neurodegenerative disease with an average life expectancy of 3 to 5 years from symptom onset. It results in the loss of motor neurons in the brain and spinal cord, leading to a steady decline in the ability to move, speak, eat, and eventually breathe.

ALS affects approximately 31,000 people in the U.S., with around 5,000 new cases diagnosed annually, according to the Centers for Disease Control and Prevention (CDC). In Europe, about 30,000 people are living with ALS, while India has an estimated 75,000 ALS patients. 

The Phase II clinical trial has enrolled 24 ALS patients across seven sites in India. The trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Usnoflast. The primary endpoint is the change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score at weeks 4, 8, and 12. Key secondary endpoints include Slow Vital Capacity (SVC) and neurofilament levels at weeks 4 and 12. 

The company further informed they initiated a Phase II clinical study of Usnoflast in Ulcerative Colitis and established Phase II proof-of-concept in CAPS patients, with data published in Clinical Pharmacology in Drug Development. The USFDA has granted Usnoflast an ‘Orphan Drug Designation’ for the treatment of Cryopyrin Associated Periodic Syndrome (CAPS), a rare autoinflammatory disease. 

However, the shares were down by 0.91 per cent to ₹1075.60 at 1.40 pm on the BSE.