Halia Therapeutics begins phase II trial of HT-6184, a first-in-class NEK7/NLRP3 inhibitor on post procedural inflammatory and pain responses
Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering a novel class of small molecule medications designed to combat inflammation, announced the initiation of its phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group clinical study (NCT06241742) to evaluate the efficacy of HT-6184, a selective and orally bioavailable first-in-class inhibitor of the NEK7/NLRP3 inflammasome, a main driver of inflammatory diseases.
The study will enroll up to 80 adults in post-surgical extraction of two or more molars, at least one of which must be partially or fully impacted in the mandibular bone. The study’s primary objective is to evaluate the effect of HT-6184 on post-procedure diagnostic biomarkers of inflammation and pain, as well as to evaluate the safety and tolerability of HT-6184.
The initiation of this trial to assess the efficacy of HT-6184 to reduce acute inflammation and pain marks another significant milestone for Halia in further evaluating the potential of targeting the NLRP3 inflammasome to treat a wide spectrum of immunological and inflammatory diseases,” said Margit M. Janát-Amsbury, MD, Ph.D., chief medical officer of Halia Therapeutics. “The recent positive results of our phase I trial investigating HT-6184 in healthy volunteers are extremely encouraging and validate the functional activity of HT-6184 in reducing inflammatory
This randomized phase II clinical study marks the second trial following the initiation in December of our phase IIa clinical study to evaluate HT-6184 for lower-risk myelodysplastic syndromes (LR-MDS),” noted Dave Bearss, Ph.D., president, and chief executive officer at Halia Therapeutics. “We look forward to assessing the potential benefit of our NLRP3 inflammasome inhibitor for patients undergoing a procedure that typically induces significant pain and inflammation and apply this to patients who suffer from many inflammation-related diseases.
• The clinical trial (NCT06241742) is a phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group study designed to evaluate the ability of HT-6184 to attenuate diagnostic biomarkers of post-procedure acute inflammation and manage pain following third molar extraction.
• Subjects will be given a single oral dose of HT-6184 or placebo before oral surgery to remove their third molar teeth and will be monitored to rate their pain intensity and for biomarkers of post-procedure acute inflammation with 5 blood draws and 2 follow-up appointments on day 1 and day 2 after surgery, in addition to follow-up phone calls 5-7 days after surgery.
• The study is being conducted at JBR/CenExcel in Salt Lake City, Utah.
Globally, over 300 million major surgical procedures are performed each year. Many of these surgeries lead to inflammatory responses that complicate recovery and lead to acute pain and loss of productivity for patients recovering from the surgery.
NLRP3, an innate immune sensor, is activated in response to various pathogenic and sterile stimuli. Activation of NLRP3 triggers the release of the pro-inflammatory cytokines IL-1ß 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-1ß 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 neurodegenerative and neuroinflammatory disorders such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis are also driven by NLRP3 activation.
HT-6184 represents an innovative approach as it 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 signalling 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 (Halia unpublished data).
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 programmes targeting NEK7 and LRRK2.
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