Zydus Life up 2% on USFDA nod for Phase II(b) clinical trial for Usnoflast

Zydus Life share rose after it received approval from USFDA to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

Zydus Life share price: Pharmaceutical company Zydus Life shares rose up to 1.93 per cent to hit an intraday high of Rs 1,013.35 per share on Monday, January 20, 2025. 

 

The rise in the Zydus Life share price came after the company announced that it has received approval from United States Food and Drug Administration (USFDA) to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS).  

 

Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor. Usnoflast has been studied in several pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). 

 

The USFDA has granted Zydus an ‘Orphan Drug Designation’ for Usnoflast to treat patients with Cryopyrin Associated Periodic Syndrome (CAPS), a rare auto-inflammatory disease. 

 

Zydus has previously completed a Phase 2(a) randomized, double-blind, placebo controlled clinical trial in 24 ALS patients across 7 clinical trial sites in India. [ClinicalTrials.gov Identifier: NCT05981040]. It is planned to present this Phase 2(a) trial data in upcoming medical conference and publish in medical journal.  

 

The Phase 2(b), randomized, double-blind, placebo-controlled, parallel-group, multicentre study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with ALS. 

 

The study consists of a 36-week treatment phase, followed by a 16-week open label extension. This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo. 

 

The change in ALSFRS-R total score from baseline through week 36 will be measured as the primary endpoint of this trial. The key secondary endpoints will include change in SVC (Slow Vital Capacity), CSF levels of NfL (neurofilament). In addition, the biomarkers including high sensitivity C-reactive protein, (hs-CRP), interleukin (IL)-18, IL6, IL-1β, NLRP3 and serum amyloid A (SAA), will also be evaluated.  

 

People living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to formation of neurofilaments which first accumulate in CSF of ALS patients, and then slowly these neurofilaments enter blood circulation.  Owing to rapid neurodegeneration, steady loss of the ability to move, speak, eat, eventually breathe, paralysis and death have been reported in ALS patients. ALS affects approximately 32,000 people in the USA and on an average 5,000 new patients are diagnosed every year with this disease in USA as per statistics from Centre for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS.  

 

About Zydus Life 

 

Zydus Lifesciences Ltd, previously known as Cadila Healthcare Ltd, is a global company in the life sciences sector. It focuses on discovering, developing, manufacturing, and marketing healthcare therapies. The company’s portfolio includes a range of products: finished dosage human formulations (such as generics, branded generics, specialty formulations including biosimilars and vaccines), active pharmaceutical ingredients (APIs), animal healthcare products, and consumer wellness products.

 

Zydus Life’s therapies cover various medical areas including gastrointestinal, cardiovascular, respiratory, pain management, cancer, inflammation, neurology, and women's health. 

 

Operating globally, the company has established markets in the US, Europe, South Africa, Japan, Brazil, and other emerging markets. Zydus Lifesciences is headquartered in Ahmedabad, Gujarat, India.  

 

Last checked, the market capitalisation of Zydus Life stood at Rs 99,717.79 crore, according to BSE. The company falls under the BSE 200 category. 

 

At 2:00 PM, Zydus Life shares were trading 0.32 per cent lower at Rs 991 per share. In comparison, BSE Sensex was trading 0.68 per cent higher at 77,139.02 levels.