Dogwood Therapeutics Starts Halneuron CINP Phase 2b Extension Study
Dogwood Therapeutics announced the commencement of a new 12-week open-label extension study for Halneuron , its non-opioid medicine for chemotherapy-induced neuropathic pain (CINP). This study will assess safety and efficacy over an additional three months, with data bolstering the planned Phase 3 development program submission to the FDA, projected for the first half of 2027. The ongoing 4-week double-blinded Phase 2b study showed a positive interim assessment, with a low dropout rate under 5%, and is expected to release top-line results in fall 2026.
Key Highlights
- Dogwood Therapeutics commenced a new 12-week open-label Halneuron CINP Phase 2b extension study.
- Patients completing the 4-week double-blinded Phase 2b study are eligible for the extension.
- Data from the extension trial will support the planned Phase 3 FDA submission package.
- Phase 3 development program is projected to start in the first half of 2027.
- Ongoing Halneuron CINP Phase 2b study showed a positive interim assessment.
- The ongoing study's overall dropout rate is under 5%.
- Top-line results for the ongoing CINP study are expected in fall 2026.
- Halneuron has been granted fast track designation from the FDA for CINP.
Price Impact
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