Halia Therapeutics announced the presentation of Phase II clinical trial data for HT-6184, a first-in-class, selective, and orally bioavailable inhibitor of the NEK7/NLRP3 inflammasome, at the 6th Inflammasome Therapeutics Summit in Boston, MA. The data, presented by CEO Dr. David J. Bearss on September 12, 2024, focused on the efficacy of HT-6184 in managing post-procedural inflammatory and pain responses.
The Phase II study (NCT06241742) was a randomized, single-dose, placebo-controlled, double-blind, parallel-group clinical trial. It assessed HT-6184's ability to attenuate diagnostic biomarkers of acute inflammation and manage pain following third molar extraction. Participants received a single oral dose of HT-6184 or a placebo before oral surgery and were monitored for safety, pain intensity, and biomarkers of post-procedure inflammation.
Targeting the NLRP3 Inflammasome
HT-6184 represents a novel therapeutic approach by targeting NEK7, an essential component of the NLRP3 inflammasome. Activation of NLRP3 leads to the release of pro-inflammatory cytokines IL-1β and IL-18, driving systemic chronic inflammation. Preclinical studies have demonstrated that HT-6184 inhibits the formation of the NLRP3 inflammasome and promotes its disassembly, thereby reducing the production and release of IL-1β and IL-18.
Clinical Implications and Future Directions
The study leverages inflammatory-induced pain as an innovative endpoint for evaluating therapeutic benefit. Dr. Bearss also participated in a panel discussion regarding the future directions of inflammasome therapeutics, highlighting the potential of HT-6184 in addressing unmet needs in chronic inflammatory disorders and neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis, where NLRP3 activation plays a significant role.
With over 300 million major surgical procedures performed globally each year, many resulting in inflammatory responses that complicate recovery, HT-6184 offers a promising strategy for improving patient outcomes by targeting the root cause of inflammation and pain.
