The trial will evaluate the efficacy of HT-6184 in reducing pain and inflammation after dental surgery. Credit: Rocksweeper / Shutterstock.

US-based biopharmaceutical company Halia Therapeutics has begun a Phase II clinical trial to assess the efficacy of its drug candidate HT-6184 in managing post-procedural inflammatory and pain responses.

The company dosed the first subject undergoing wisdom tooth extraction with HT-6184.

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The placebo-controlled, double-blind trial aims to evaluate the potential of HT-6184 to reduce diagnostic biomarkers of acute inflammation and pain following the procedure after the third molar extraction.

It will enrol up to 80 adults who are undergoing the surgical removal of two or more molars, with a minimum of one being partially or fully impacted in the mandibular bone.

Participants will receive a single oral dose of HT-6184 or a placebo before their oral surgery. They will subsequently be monitored for pain intensity and biomarkers of acute inflammation through five blood draws.

This is in addition to two follow-up appointments on the first and second days following surgery, along with follow-up phone calls five to seven days post-operation.

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The study’s primary objective is to evaluate the drug’s effect on post-procedure biomarkers of inflammation and pain, as well as assess its safety and tolerability.

HT-6184 is an orally bioavailable inhibitor of the NEK7/NLRP3 inflammasome, which is known to play a significant role in inflammatory diseases.

The clinical trial is being conducted at JBR/CenExcel in Salt Lake City, Utah.

Halia Therapeutics chief medical officer Margit Janát-Amsbury said: “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.

“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 cytokines.”