Halia Therapeutics to Update Phase II HT-6184 Data at 6th Inflammasome Summit

Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Lehi, Utah, focuses on developing innovative solutions for inflammatory and neurodegenerative diseases. Recently, the company announced that its President and CEO, Dr. David J. Bearss, will present the findings of their Phase II clinical trial on HT-6184. The presentation will occur at the 6th Inflammasome Therapeutics Summit in Boston, Massachusetts, on September 12, 2024.

HT-6184 stands out as a first-in-class, orally bioavailable inhibitor targeting the NEK7/NLRP3 inflammasome. This investigational drug is designed to improve the quality of life for patients by addressing chronic inflammatory disorders and neurodegenerative diseases. The Phase II study, which is a randomized, single-dose, placebo-controlled, double-blind, parallel-group trial, evaluated the effectiveness of HT-6184 in managing post-procedural inflammation and pain.

The clinical trial included patients undergoing third molar extraction. Participants received either a single oral dose of HT-6184 or a placebo prior to their surgery and were monitored for safety, pain intensity, and biomarkers of acute inflammation. This study was conducted at CenExcel JBR in Salt Lake City, Utah.

The Inflammasome Therapeutics Summit is an annual event that brings together biopharmaceutical professionals and top academics to discuss advancements in inflammasome-targeting therapies. Dr. Bearss will present a session titled "Leveraging Inflammatory-Induced Pain as an Innovative & Alternative Endpoint for a Time-Effective Measurement of Therapeutic Benefit" and will also participate in a panel discussion on the future directions of inflammasome therapeutics.

The mechanism of action of HT-6184 revolves around its selective inhibition of the NEK7/NLRP3 inflammasome. NLRP3, a crucial immune sensor, activates in response to pathogenic and sterile stimuli, leading to the release of pro-inflammatory cytokines IL-1β and IL-18 and causing pyroptosis, a type of cell death. These processes are linked to systemic chronic inflammation. Halia's preclinical models have shown that HT-6184 prevents the formation of the NLRP3 inflammasome and promotes its disassembly, thus inhibiting the production and release of IL-1β and IL-18. This mechanism is believed to be effective against a range of conditions, including fibrotic, dermatological, and auto-inflammatory diseases, as well as significant neurodegenerative disorders like Alzheimer's, Parkinson's, and multiple sclerosis.

HT-6184 represents an innovative therapeutic approach by specifically targeting NEK7, a protein essential for the assembly and maintenance of NLRP3 activity. In preclinical models, inhibiting NEK7 disrupted the formation of the NLRP3 inflammasome complex and reduced the inflammatory response. Additionally, HT-6184 promoted the disassembly of the inflammasome once activated.

Halia Therapeutics is committed to discovering and developing novel therapeutics to address chronic inflammatory and neurodegenerative diseases. Besides HT-6184, the company is also focusing on LRRK2. HT-6184 has completed a Phase I study evaluating its safety and tolerability and has also completed a Phase II trial for its efficacy in reducing post-procedure inflammation and pain. The company is currently conducting a Phase II trial to investigate the efficacy of HT-6184 in treating lower-risk myelodysplastic syndromes (LR-MDS).

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