Zydus achieves positive Proof-of-Concept in its Phase 2 clinical study of ZYIL1

8 Sep 2022 , 10:50 AM

Zydus Lifesciences Limited (previously Cadila Healthcare Ltd.), a global Lifesciences business focused on the discovery, announced that it has achieved a favourable Proof-of-Concept in its Phase 2 clinical trial of ZYIL1.

CAPS is an orphan illness caused by NLRP3 activating mutations and is a rare, life-long auto-inflammatory disorder. Chronic inflammation caused by IL-1beta secretion causes urticaria-like rash, fever, arthralgia, and an elevated risk of amyloidosis in CAPS patients.

Sensorineural hearing loss, migraine, headache, aseptic meningitis, and myalgia are other common neurological problems in CAPS patients. The most severe form of CAPS, Neonatal Onset Multisystem Inflammatory Disease (NOMID), has been linked to bone abnormalities and neurological deficits.

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Subjects with Cryopyrin Associated Periodic Syndromes (CAPS) were examined in a Phase 2 trial conducted in Australia.

ZYIL1 displayed rapid oral absorption. ZYIL1 is particularly powerful in human whole blood (IC50 in the nanomolar range) and suppresses inflammation mediated by the NLRP3 inflammasome. A significant impact on illness indicators such as CRP, Serum Amyloid A (SAA), IL-6, and WBC was also detected.

ZYIL1 was shown to be safe and well-tolerated, with no Serious Adverse Events (SAEs). In this Phase 2 study, liver and renal function testing revealed no abnormalities.

CAPS patients with verified NLRP3 mutations experiencing CAPS-related flare-ups demonstrated fast clinical improvement as early as day 3 when treated with ZYIL1 in the Phase 2 Proof-of-Concept trial, which lasted until the conclusion of therapy.

At around 10.55 AM, Zydus Lifesciences was trading at Rs376.70 up by 0.2% from its previous closing of Rs375.95 on the BSE. The scrip opened at Rs379 and touched intraday high and low of Rs379.90 and Rs376.50 respectively.

For feedback and suggestions, write to us at [e-mail]