Zydus gets permission to conduct Phase II clinical trial for CAPS patients in Australia

Global pharmaceutical company Zydus Cadila on Monday received approval to commence Phase II clinical study of its upcoming product with patients suffering from Cryopyrin-Associated Periodic Syndrome (CAPS) in Australia. According to a press release, the company said that it received permission to initiate the Phase II clinical study of its MLRP3 inhibitor ‘ZYIL1’ in patients with CAPS in Australia. Now, the clinical trial will study the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with CAPS - a rare life-long auto-inflammatory condition, classified under orphan diseases.

CAPS patients experience multiple neurological complications like sensorineural hearing loss, migraine, headache, aseptic meningitis and myalgia. Bone deformities and neurological impairment have also been reported in Neonatal Onset Multisystem Inflammatory Disease (NOMID), which is the most severe form of CAPS. 

Pankaj R. Patel, Chairman of Cadila Healthcare, said, “The Cryopyrin Associated Periodic Syndromes (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.” 

'ZYIL1' safe, well-tolerated in Phase I trial

Further, as per the press note, Zydus Cadila’s ‘ZYIL1’ is a novel oral small molecule NLRP3 inhibitor. It was found to be safe and well-tolerated in Phase I trials. The upcoming product has a high binding affinity in human whole blood, and can selectively suppress inflammation caused by the NLRP3 inflammasome.

In the second Phase I trial, multiple-dose studies of ZYIL1 was conducted to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following repeated dosing for 14 days in healthy subjects. It was found that ZYIL1 had a rapid oral absorption and steady state.

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