Pharma Focus America

Halia Therapeutics Completes Patient Recruitment for Phase I Clinical Trial Assessing HT-6184 in Treating Chronic Inflammation

Tuesday, August 08, 2023

Halia Therapeutics, a biopharmaceutical company in the clinical stage, dedicated to developing innovative treatments for a variety of chronic inflammation-driven diseases, has proudly declared the successful completion of participant enrollment for the Phase I clinical trial (NCT05447546) investigating HT-6184, its lead compound, as a potential remedy for chronic inflammation. HT-6184 is distinctive as a novel drug candidate designed to target the NEK7 protein via an allosteric mechanism, effectively inhibiting NLRP3 inflammasome activity. Anticipated data results from the trial are slated for release in Q4 2023.

CEO of Halia Therapeutics, David J. Bearss, Ph.D., conveyed satisfaction with this achievement: "We are thrilled to have concluded participant enrollment for our study assessing our lead program, HT-6184. As NLRP3-induced chronic inflammation plays a pivotal role in numerous diseases, advancing a potent treatment targeting a key driver of systemic chronic inflammation could bear significant potential in attenuating inflammatory signaling and reducing the prevalence of chronic illnesses in human populations."

The Phase I trial, characterized by randomization, placebo control, and single-center operation, centered on single and multiple ascending doses of HT-6184 across 64 healthy adult participants. The objectives encompassed assessing the drug's safety, tolerance, pharmacokinetics (PK), and pharmacodynamics (PD), with each cohort exploring four escalating single doses and four escalating multiple doses (a single dose level for each cohort).

NLRP3, a critical element, instigates the release of pro-inflammatory cytokines IL-1β and IL-18, triggering pyroptosis, a cell death process, ultimately leading to systemic chronic inflammation. Halia's intervention to inhibit NLRP3 aims to impede the formation of the NLRP3 inflammasome and facilitate its disassembly post-formation, effectively curbing the generation and release of IL-1β and IL-18. The sustained activation of NLRP3 inflammasome is implicated in the genesis and progression of diverse conditions, encompassing fibrotic, dermatological, and auto-inflammatory disorders. Furthermore, notable neurological disorders, including Alzheimer's disease, Parkinson's disease, and multiple sclerosis, are also influenced by NLRP3 activation.

Central to Halia's approach, HT-6184, the pioneering compound, uniquely targets the NEK7 protein through an allosteric mechanism. NEK7 plays a pivotal role in assembling and maintaining the NLRP3 inflammasome, rendering it indispensable. In preclinical models, Halia demonstrated that disrupting NEK7's binding to NLRP3 results in the breakdown of the NLRP3 inflammasome complex, effectively arresting inflammasome signaling and mitigating the inflammatory response. Additionally, preclinical models illustrated that apart from disrupting NLRP3 inflammasome formation, HT-6184 promotes the disassembly of an activated inflammasome complex.

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