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Halia Therapeutics Launches Phase II Trial to Evaluate Effectiveness of HT-6184, a Unique NEK7/NLRP3 Inhibitor, in Managing Post-Procedural Inflammation and Pain

Friday, February 16, 2024

Halia Therapeutics has commenced its Phase II randomized clinical trial, designated as NCT06241742, to evaluate the effectiveness of HT-6184, a novel medication targeting the NEK7/NLRP3 inflammasome, in combating inflammation. This trial aims to enroll around 80 adults undergoing post-surgical extraction of impacted molars, with the primary objective being to assess HT-6184's impact on post-procedure inflammation biomarkers and pain, alongside evaluating its safety and tolerability.

Halia Therapeutics, expressed optimism for the trial, citing promising results from the Phase I trial in healthy volunteers, which demonstrated HT-6184's ability to effectively reduce inflammatory cytokines. Dave Bearss, President and CEO of Halia Therapeutics, emphasized the importance of evaluating HT-6184's potential benefits for patients undergoing procedures causing significant pain and inflammation, extending its potential application to various inflammation-related diseases.

The Phase II trial (NCT06241742) is a randomized, double-blind, placebo-controlled study focused on assessing HT-6184's ability to alleviate acute inflammation and manage pain post-third molar extraction. Participants will receive a single oral dose of HT-6184 or placebo before surgery, with subsequent monitoring of pain intensity and inflammation biomarkers through blood samples and follow-up appointments. The trial is conducted at JBR/CenExcel in Salt Lake City, Utah.

Inflammatory responses following surgical procedures affect millions globally, complicating recovery and causing acute pain and productivity loss. Halia's approach targets the NLRP3 inflammasome, a key mediator of systemic chronic inflammation. By inhibiting NLRP3, HT-6184 prevents the release of pro-inflammatory cytokines and disrupts inflammasome formation and activity, offering promise in various inflammatory conditions, including neurodegenerative disorders.

HT-6184 represents a groundbreaking approach as the first drug candidate targeting NEK7 via an allosteric mechanism. NEK7's role in NLRP3 assembly and activity makes it a crucial target for reducing inflammation. Preclinical studies have demonstrated HT-6184's efficacy in disrupting inflammasome formation and promoting its disassembly, thus mitigating the inflammatory response.

The initiation of this Phase II trial marks a significant step in assessing HT-6184's therapeutic potential in addressing inflammation and pain, with implications for a broad spectrum of inflammatory diseases.



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