Dogwood Therapeutics Launches Halneuron 12-Week CINP Extension Study Ahead of Phase 3 Start

With a Phase 3 program projected to begin in H1 2027, Dogwood Therapeutics has opened a 12-week open-label extension study for Halneuron® in chemotherapy-induced neuropathic pain, a move that signals near-term CMC and manufacturing scale-up planning for any contract partners in the neuropathic pain space. The extension follows a pre-planned interim analysis of the ongoing 4-week double-blinded Phase 2b study, which supported continuation with a target sample size of 210–240 patients to achieve 80% statistical power.

Patients completing the blinded 4-week treatment period are now eligible to enroll in the follow-on trial, with several already enrolled. The extension will evaluate safety and efficacy across multiple dosing regimens over three months, generating data intended to strengthen the end-of-Phase 2 submission package Dogwood plans to file with FDA. Top-line results from the double-blinded portion are expected in fall 2026, with a current dropout rate below 5%, notably lower than rates observed in comparable FDA-approved chronic pain studies.

The clinical context underscores the unmet need driving this program. Interim demographic data showed that enrolled patients had a mean CINP duration exceeding five years; there are currently no FDA-approved treatments for this indication. Halneuron® holds FDA Fast Track designation for CINP and acts as a NaV 1.7-selective voltage-gated sodium channel modulator, a non-opioid mechanism with established relevance to pain signal attenuation.

For QA directors and regulatory leads tracking the asset, the extension study's open-label design and multi-regimen dosing structure will require robust pharmacovigilance documentation and comparability data as the program transitions toward Phase 3. CMC teams at any prospective manufacturing partners should note that a 2027 Phase 3 start compresses the timeline for process validation, analytical method transfer, and supply chain qualification under 21 CFR Part 211 and applicable ICH Q10 quality system requirements.

The end-of-Phase 2 FDA meeting, supported by the combined Phase 2b and extension data package, will be a critical checkpoint for determining the Phase 3 protocol design and the manufacturing scale required to support it.

Source: Dogwood Therapeutics, Inc. via GlobeNewswire, May 18, 2026.