Zydus Lifesciences' Usnoflast Shows Promise in ALS Phase II(a) Trial

11 Sep 2024 , 11:00 AM

Zydus Lifesciences Ltd. announced on September 10 the successful completion of a Phase II(a) clinical trial for its novel NLRP3 inflammasome inhibitor, Usnoflast (ZYIL1), in patients with Amyotrophic Lateral Sclerosis (ALS).

The 12-week trial demonstrated that Usnoflast is safe, achieving the desired levels in both blood and spinal fluid. It also helped reduce Neurofilament Light chain (NfL) levels, a key marker for nerve damage, indicating potential benefits for neurodegenerative conditions.

Improvements were observed in ALS Functional Rating Scale (ALSFRS-R) scores and Slow Vital Capacity (SVC), suggesting Usnoflast may help slow ALS progression, which impacts muscle control.

At the time of writing on September 11, 2024 at 10:58 am, shares of Zydus Lifesciences Ltd is trading at ₹3595 which is a 0.0070% dip than the previous close. Zydus Lifesciences Ltd has gained a total of 24% in the last one year, and almost 2% since the beginning of the year.

Usnoflast is a new NLRP3 inhibitor showing promise in the Phase II(a) trial, offering hope for ALS patients, a disease characterized by severe inflammation and rapid muscle control loss.

ALS leads to nerve fiber damage, neurofilament buildup in spinal fluid, and progressive loss of motor functions, often resulting in paralysis and death.

This study is a significant advancement in developing innovative therapies for neurodegenerative diseases, according to Zydus Lifesciences Ltd.

In the US, ALS affects around 32,000 people, with 5,000 new diagnoses annually, while Europe has over 30,000 cases and India approximately 75,000. Average survival post-diagnosis is two to five years, often due to respiratory failure.

Pankaj Patel, Chairman of Zydus Lifesciences Ltd, highlighted Usnoflast as a groundbreaking innovation, noting its therapeutic efficacy in reducing neurofilaments in ALS patients’ CSF.

Usnoflast (ZYIL1) is an oral small-molecule NLRP3 inhibitor, effective in pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). It has demonstrated high potency and effective distribution in the brain and CSF in various nonclinical species.