Dogwood Therapeutics Files New IP To Extend Halneuron® Exclusivity It’s Non-Opioid Pain Therapy As Phase 2b Trial Advances

Dogwood Therapeutics, a company focused on developing new treatments for pain and neuropathic disorders and maintains a pipeline that includes two first-in-class candidates: Halneuron® and SP16 IV. Early clinical research on Halneuron® has already shown promising reductions in pain related to cancer and chronic CINP, supporting its potential as a targeted, non-opioid therapy that modulates the NaV 1.7 sodium channel to interrupt pain signalling.

Dogwood Therapeutics has  announced that it has submitted new filings for intellectual property protection covering synthetic Halneuron®, its lead investigational therapy. If approved, the extended exclusivity would run through 2045, with the potential for further patent term restoration. This move strengthens the company’s long-term IP position as Halneuron® advances through late-stage development.

"We plan to use synthetically manufactured Halneuron® in both Phase 3 development and commercialization," said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. "This new synthetic process builds on our proprietary and best-in-class manufacturing know-how, with potential to reset our exclusivity period for 20 years, thus providing ample opportunity to deliver Halneuron's® full commercial potential."

Halneuron®, a non-opioid NaV 1.7 inhibitor, is currently in a Phase 2b clinical trial for pain conditions, most notably chemotherapy-induced neuropathic pain (CINP). The program has received Fast Track designation from the U.S. Food and Drug Administration, underscoring its potential to address a serious unmet medical need. Positive results from this study are expected to guide discussions with the FDA on the Phase 3 development strategy.