Dogwood Announces Completion of Enrollment in Ongoing Halneuron® Phase 2b Trial
- Enrollment of 239 Patients Meets Upper End of Planned Enrollment Target Range -
- Topline Data Expected in November 2026 -
ATLANTA, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a company that focuses on developing first-in-class, new non-opioid medicines to treat pain and neuropathy, today announced the completion of patient enrollment in its ongoing Halneuron® Phase 2b Chemotherapy Induced Neuropathic Pain (“CINP”) trial. The Company anticipates topline data readout of the study in November 2026. Positive results from this study, if achieved, would represent a significant milestone for the Company, as well as for patients suffering from CINP, a condition for which there are no FDA approved treatments.
“Health care provider and CINP patient interest in participating in our HAL-CINP Phase 2b CINP trial was very high, which led us to recruit to the top of our projected target range,” said Greg Duncan, Chief Executive Officer of Dogwood Therapeutics. “Based on our encouraging interim analysis, we remain confident that Halneuron® treatment can demonstrate pain improvement when compared with placebo treated patients when Phase 2b topline data are reported this November.“
Halneuron® CINP Phase 2b Trial (“HAL-CINP”) Overview (NCT06848348)
HAL-CINP is a randomized, phase 2b clinical trial evaluating the efficacy and safety of Halneuron® compared with placebo in 239 patients with moderate to severe neuropathic pain caused by prior platinum and/or taxane-based chemotherapy. Participants receive 8 subcutaneous doses of Halneuron® or placebo over a 14-day period and are followed for a total of 28 days for safety and effectiveness. The primary endpoint for this study is the change from baseline to week four in the weekly average of daily 24-hour recall pain intensity scores. The study is being conducted at approximately 25 sites in the U.S. Secondary measures will assess Halneuron’s® treatment effects on sleep, fatigue, neuropathy symptoms and overall patient health.
About Dogwood Therapeutics
Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing first-in-class, non-opioid medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuron® and SP16 IV.
Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain CINP. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (“LRP1”) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16’s activity as an LRP1 agonist in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b CIPN trial is fully funded by the National Cancer Institute.
Dogwood Therapeutics’ largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit www.dwtx.com.
Forward-Looking Statements:
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing, enrollment, design and results of current and future clinical studies relating to Dogwood’s product candidates; whether interim or final clinical data will support continued development, regulatory submissions or approval; and Dogwood’s ability to finance its operations. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the most recently filed Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.
Investor Relations:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
