– Halia expects to release data from the Phase I trial in Q4 2023
SALT LAKE CITY, Aug. 7, 2023 /PRNewswire/ — Halia Therapeutics, a clinical-stage biopharmaceutical company advancing innovative medicines to treat a broad range of diseases that are driven by chronic inflammation, today announced the completion of enrollment in its Phase I study (NCT05447546) evaluating its lead asset, HT-6184, for chronic inflammation. HT-6184 is the first drug candidate to target the protein NEK7 through an allosteric mechanism to inhibit NLRP3 inflammasome activity. Data readout for the trial is expected in the fourth quarter of 2023.
“We are pleased to have completed enrollment in our study evaluating our lead program, HT-6184,” said David J. Bearss, Ph.D., CEO of Halia Therapeutics. “Given that NLRP3-induced chronic inflammation is at the root of many diseases, clinical development of an effective medicine that targets an important driver of systemic chronic inflammation could have significant implications in reducing inflammatory signaling and mitigating the risk of chronic diseases in humans.”
This Phase I, randomized, placebo-controlled, single-center, single and multiple ascending dose study, evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HT-6184 in 64 healthy adult volunteers. Four ascending single and four ascending multiple doses (1 dose level per cohort) were investigated.
Activation of NLRP3 triggers the release of the pro-inflammatory cytokines IL-1β and IL-18 and induces a lytic cell death process called pyroptosis. These processes lead to systemic chronic inflammation. Halia’s therapeutic inhibition of NLRP3 prevents the formation of the NLRP3 inflammasome and promotes its disassembly once formed, thereby inhibiting the production and release of IL-1β and IL-18. Persistent activation of the NLRP3 inflammasome is thought to drive the onset and progression of many conditions, including fibrotic, dermatological, and auto-inflammatory diseases. Significant neurological disorders such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis are also driven by NLRP3 activation.
HT-6184 is the first drug candidate to target the protein NEK7 through an allosteric mechanism. NEK7 is an essential component of the NLRP3 inflammasome and is critical for its assembly and the maintenance of NLRP3 activity. In preclinical models, Halia has shown that inhibiting the ability of NEK7 to bind to NLRP3 leads to a disruption in the formation of the NLRP3 inflammasome complex, thereby inhibiting the signaling from the inflammasome and reducing the inflammatory response. Preclinical models also showed that in addition to disrupting the formation of the NLRP3 inflammasome, HT-6184 promotes the disassembly of the inflammasome once activated.
About Halia Therapeutics, Inc.
Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients’ lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia’s lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, is currently completing a Phase 1 study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects. The company is headquartered in Salt Lake City, Utah. For more info, visit www.haliatherapeutics.com or follow us on LinkedIn and Twitter (X).
Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
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