Halia Launches Phase II Trial of HT-6184 for Post-Surgical Inflammation and Pain

Halia Therapeutics, a biopharmaceutical firm in the clinical stage, has embarked on a Phase II clinical trial to assess the effectiveness of HT-6184, a groundbreaking NEK7/NLRP3 inflammasome inhibitor, in mitigating inflammation and pain after surgical procedures. The study, designated NCT06241742, is a randomized, single-dose, placebo-controlled, double-blind, and parallel-group endeavor that will involve up to 80 adults who have undergone extraction of two or more molars, with at least one being impacted in the lower jaw. The primary goal is to measure HT-6184's impact on diagnostic biomarkers indicative of inflammation and pain post-extraction, as well as to scrutinize its safety and tolerability.

The Chief Medical Officer of Halia Therapeutics, Margit M. Janát-Amsbury, MD, Ph.D., has emphasized the significance of this trial, which aims to gauge HT-6184's capacity to alleviate acute inflammation and pain. The drug's potential to target the NLRP3 inflammasome could be instrumental in addressing a broad range of immunological and inflammatory diseases. The Phase I trial results, which demonstrated HT-6184's ability to reduce inflammatory cytokines in healthy individuals, were deemed highly promising.

Dave Bearss, Ph.D., President and Chief Executive Officer of Halia Therapeutics, highlighted that this Phase II study follows the initiation of another Phase IIa study in December, which is focused on evaluating HT-6184 for lower-risk myelodysplastic syndromes (LR-MDS). The company is eager to explore the benefits of their NLRP3 inflammasome inhibitor in patients who experience significant pain and inflammation due to surgical procedures and to extend this to individuals suffering from various inflammation-related conditions.

The Phase II clinical trial is structured to evaluate HT-6184's efficacy in reducing acute inflammation and managing pain following the extraction of wisdom teeth. Participants will receive a single oral dose of either HT-6184 or a placebo prior to their oral surgery. They will then be monitored for pain intensity and inflammation biomarkers through blood draws and follow-up appointments on the first and second days post-surgery, along with follow-up calls later in the week. The trial is taking place at JBR/CenExcel in Salt Lake City, Utah, and more details can be accessed on clinicaltrials.gov or by contacting the provided phone number.

In the context of post-procedural inflammation, it is noted that over 300 million major surgeries are conducted worldwide annually, many of which result in inflammatory responses that hinder recovery and cause acute pain, impacting patients' productivity.

NLRP3, recognized as an innate immune sensor, is activated by a variety of stimuli and triggers the release of pro-inflammatory cytokines IL-1β and IL-18, leading to pyroptosis, a form of cell death, and contributing to systemic chronic inflammation. Halia's therapeutic strategy involving NLRP3 inhibition aims to prevent the formation and promote the disassembly of the NLRP3 inflammasome, thereby curbing the production and release of IL-1β and IL-18. Persistent NLRP3 inflammasome activation is linked to the development and progression of several conditions, including fibrotic, dermatological, and auto-inflammatory diseases, as well as significant neurodegenerative and neuroinflammatory disorders such as Alzheimer's, Parkinson's, and multiple sclerosis.

HT-6184 is a pioneering drug candidate that targets the NEK7 protein via an allosteric mechanism. NEK7 is vital for the assembly and function of the NLRP3 inflammasome. Halia's research in preclinical models has shown that inhibiting NEK7's interaction with NLRP3 disrupts the inflammasome complex formation, inhibiting its signaling and reducing inflammation. Furthermore, HT-6184 has been shown to promote the disassembly of the activated inflammasome.

Halia Therapeutics is dedicated to discovering and developing innovative therapeutics aimed at improving the lives of patients with chronic inflammatory and neurodegenerative diseases, with a focus on NEK7 and LRRK2 as initial targets. The company's lead candidate, HT-6184, has completed a Phase I study assessing its safety and tolerability in healthy volunteers and is currently in a Phase II trial for lower-risk myelodysplastic syndromes (LR-MDS). The Utah-based company continues its mission to advance novel treatments for various inflammatory conditions.