Zydus allowed to conduct Phase 2 trial of ZYIL1 in CAPS patients in Australia

Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd. 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 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 has high binding affinity in human whole blood, and can selectively supress inflammation caused by the NLRP3 inflammasome. In non-clinical species including mice, rats and non-human primates, ZYIL1 has demonstrated brain penetration. The efficacy of ZYIL1 has been established in a number of validated pre-clinical models of Neuroinflammation, Parkinson's Disease, Inflammatory Bowel Disease (IBD), Multiple Sclerosis (MS), Sepsis and acute lung injury models of Acute Respiratory Distress Syndrome (ARDS). The candidate, ZYIL1, has an acceptable ADME profile, with good safety margin.

ZYIL1 was found to be safe and well-tolerated in Phase I trials. 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. ZYIL1 showed rapid oral absorption and steady state was achieved at 48h. Inhibition of IL-1beta biomarker in Phase I trial demonstrated proof-of-biology

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