Dogwood Reports Significant Pain Improvement in Halneuron Phase 2b Interim Analysis
Dogwood Therapeutics announced results from an interim analysis of 97 patients who had completed treatment in the ongoing Halneuron Phase 2b chemotherapy induced neuropathic pain study. The independent statistical review committee reviewed unblinded patient treatment data from the Phase 2b trial and concluded that Halneuron treated patients are demonstrating separation from placebo treated patients in terms of pain improvement over the four-week study. Based on the current Phase 2b trial enrollment pace and the interim assessment results, the Company continues to expect to have top-line results available during Q3 2026. Current study patient enrollment trends are projected to provide statistical power of approximately 80% to 85% to detect a Halneuron treatment difference. This preliminary evidence of a Halneuron treatment effect is noteworthy as patients in the interim analysis population present an average duration of CINP of 5 years and 67% of patients that met entry criteria were also being treated with stable doses of other chronic pain medicines, including pregabalin, gabapentin, duloxetine, and opioids. In addition, the overall study dropout rate of approximately 4.4% is far below rates typically observed with other FDA approved chronic pain medicines. While still blinded, the Company believes these findings reaffirm the encouraging safety and tolerability profile of Halneuron observed in previous clinical trials.
Get Free Real-Time Notifications for Any Stock
Analyst Views on DWTX
About DWTX
About the author
Dogwood Therapeutics Raises $12.5 Million to Advance Halneuron® Development
- Funding Amount: Dogwood Therapeutics successfully raised approximately $12.5 million through a registered direct offering and concurrent private placement, which is expected to be utilized for advancing the clinical development of Halneuron®, thereby enhancing the company's innovation in non-opioid medications.
- Equity Structure: The financing involves the issuance of 4,386,037 shares of common stock and corresponding warrants at a price of $2.85 per share, reflecting market recognition of the company's research potential and potentially boosting investor confidence.
- Strategic Use: The company plans to use the net proceeds from the offering to support the Phase 2b clinical trial of Halneuron® while also pursuing strategic opportunities to strengthen its research portfolio, aiming to improve care standards for patients suffering from chemotherapy-induced pain and neuropathy.
- Market Outlook: This financing not only provides Dogwood with additional capital support but also lays the groundwork for future Phase 3 clinical development, further solidifying its market position in the biopharmaceutical industry.
Dogwood Therapeutics Reports Positive Interim Results for Halneuron in Chemotherapy-Induced Neuropathic Pain
- Clinical Trial Progress: Dogwood Therapeutics' Phase 2b trial for chemotherapy-induced neuropathic pain shows that 97 patients experienced significant pain improvement over four weeks, with a dropout rate of only 4.4%, indicating the potential of Halneuron as a viable treatment option.
- Market Need: With no FDA-approved treatments for moderate-to-severe chemotherapy-induced neuropathic pain, Halneuron's success could address a significant unmet medical need for cancer survivors suffering from this debilitating condition.
- Financial Challenges: Despite the encouraging clinical data, Dogwood's stock plummeted nearly 24% due to concerns over its limited cash reserves of $10.1 million, which only provide operational runway through the first quarter of 2026, raising investor apprehensions.
- Future Outlook: The company expects to release top-line results in the third quarter of 2026, and if successful, this could represent the first statistically significant study under FDA chronic pain guidance, potentially paving the way for a Phase 3 registration program.
