Synopsis-
Zydus announced today that it has received permission to initiate the Phase II (a) clinical study of its NLRP3 inhibitor “ZYIL1” in patients with Cryopyrin- Associated Periodic Syndrome (CAPS) in Australia.
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.
TGA Gives Clear Signal To Zydus nod to conduct Phase II clinical study in patients with CAPS – Aus
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.
About Cryopyrin-Associated Periodic Syndrome
Cryopyrin-associated periodic syndrome (CAPS) is a group of rare, heterogeneous autoinflammatory disease characterized by interleukin 1β-mediated systemic inflammation and clinical symptoms involving skin, joints, central nervous system, and eyes. It encompasses a spectrum of three clinically overlapping autoinflammatory syndromes including familial cold autoinflammatory syndrome (FCAS, formerly termed familial cold-induced urticaria), the Muckle–Wells syndrome (MWS), and neonatal-onset multisystem inflammatory disease (NOMID, also called chronic infantile neurologic cutaneous and articular syndrome or CINCA) that were originally thought to be distinct entities, but in fact share a single genetic mutation and pathogenic pathway, and keratoendotheliitis fugax hereditaria in which the autoinflammatory symptoms affect only the anterior segment of the eye.
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