Zydus’ cytokine inhibitor moves into clinical trial

Pharmaceutical manufacturer Zydus Cadila said it received permission to initiate clinical trials for ZYIL1, an oral small molecule NLRP3 inhibitor, as an anti-inflammatory agent.

The molecule is being explored for treating a variety of inflammation-related conditions, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, gastro-intestinal diseases (inflammatory bowel disease), renal diseases and CNS diseases.

The drug works by inhibiting the release of NLRP3 inflammasomes, which are involved in triggering inflammation by the production and release of pro-inflammatory cytokines IL-1β and IL-18.

The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYIL1 in healthy human volunteers.

The company said that ZYIL1 demonstrated promising efficacy in a number of validated pre-clinical models of Inflammatory Bowel Disease (IBD), Multiple Sclerosis (MS), Sepsis and acute lung injury models of Acute Respiratory Distress Syndrome (ARDS).

“The studies have demonstrated that ZYIL1 can selectively supress inflammation caused by the NLRP3 inflammasome. The candidate, ZYIL1, has an acceptable ADME profile, with high safety margin,” it claimed.

Inflammation is considered an aggravating factor in COVID-19. Many people have lost their lives due to run-away inflammation and the so-called cytokine storm, and doctors are always on the lookout for novel ways to bring this phenomenon under control.

Zydus Cadila Group, which employs nearly 25,000 people worldwide including 1,400 scientists, develops and sells a range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines.