Dogwood Therapeutics Inc. (DWTX) yesterday announced positive interim results from its ongoing Phase 2b study of Halneuron in chemotherapy-induced neuropathic pain, with treated patients demonstrating clear separation from placebo in pain improvement assessments.
Chemotherapy-induced neuropathic pain (CINP), is a debilitating condition affecting cancer survivors, often persisting for years and inadequately managed by existing therapies such as pregabalin, gabapentin, duloxetine, and opioids. There are currently no FDA-approved treatments for moderate-to-severe CINP, leaving a significant unmet medical need.
The Phase 2b trial enrolled 97 patients for interim analysis, with an average CINP duration of five years. Results showed Halneuron-treated patients experienced meaningful pain improvement compared to placebo over four weeks.
Importantly, the dropout rate was only 4.4%, far below rates typically observed with other FDA-approved chronic pain medicines.Halneuron, a non-opioid NaV1.7 sodium channel inhibitor, has been granted fast track designation by the FDA.
The company expects top-line results in the third quarter of 2026, with current enrolment trends projected to provide 80-85% statistical power to detect treatment differences.
Dogwood's pipeline also includes SP16 IV, a low-density lipoprotein receptor-related protein-1 agonist funded by the National Cancer Institute, with potential to repair nerve damage and reduce inflammation.
Despite the encouraging interim data, Dogwood's stock plunged nearly 24% yesterday, largely due to concerns over its limited cash reserves of $10.1million, which provides operational runway only through the first quarter of 2026.
Dogwood emphasized that success in this trial could represent the first statistically significant CINP study under FDA chronic pain guidance, potentially paving the way for Phase 3 registration program.
DWTX has traded between $1.87 and $29.28 over the past year. The stock closed yesterday's trading at $4.84, down 24.96%.
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