Drug firm Zydus Cadila on Monday said it has received approval to commence Phase II clinical study of its upcoming product with patients suffering with Cryopyrin-Associated Periodic Syndrome (CAPS) in Australia.
The company has received permission to initiate the Phase II clinical study of its NLRP3 inhibitor ’ZYIL1’ in patients with CAPS in Australia.
The clinical trial in Australia will study the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with CAPS, Zydus Cadila said in a statement.
CAPS is a rare life-long auto-inflammatory condition, and is classified under orphan diseases. CAPS patients also experience multiple neurological complications like sensorineural hearing loss, migraine, headache, aseptic meningitis and myalgia.
"The CAPS patient community has very limited treatment options and there is a huge unmet medical need. We are committed to develop novel therapies, and ZYIL1 has potential to treat several autoimmune diseases," Cadila Healthcare Chairman Pankaj R Patel noted.
Cadila Healthcare is the listed entity of the Ahmedabad-based drug maker. ZYIL1 is a novel oral small molecule NLRP3 inhibitor. It was found to be safe and well-tolerated in Phase I trials.
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