Dogwood Therapeutics announced Phase 2b trial of Halneuron® for chemotherapy-induced neuropathic pain, expected to start Q1 2025.
Quiver AI Summary
Dogwood Therapeutics, Inc. announced that it will begin dosing patients in its Phase 2b clinical trial, HALT-CINP, in Q1 2025 to study Halneuron®, a novel Nav 1.7 inhibitor aimed at treating chemotherapy-induced neuropathic pain (CINP). Previous trials indicate Halneuron® effectively reduces cancer-related pain without addiction potential. Given that one-in-three chemotherapy patients experience chronic neuropathy and there are currently no approved treatments for it, this trial addresses a significant unmet medical need in a market valued around $1.5 billion. The company, which has a strong track record in developing pain therapeutics, highlights the urgency for effective treatments as many cancer patients are treated with opioids for pain relief. Additionally, Dogwood is advancing other innovative programs, including antiviral treatments for conditions like fibromyalgia and Long-COVID.
Potential Positives
- Dogwood Therapeutics has announced the dosing of the first patient in its Phase 2b clinical trial for Halneuron®, indicating progress in clinical development for a novel treatment targeting a significant unmet medical need in chemotherapy-induced neuropathic pain.
- Halneuron® has previously demonstrated statistical significance in pain reduction in a Phase 2 trial, showcasing its potential effectiveness in treating cancer-related pain without addiction risk.
- The market for chronic neuropathy, particularly related to chemotherapy, is substantial, estimated at approximately $1.5 billion, highlighting significant commercial potential for Halneuron®.
- The leadership team has a history of successfully developing and commercializing blockbuster medicines in pain management, which can instill confidence in investors and stakeholders regarding the potential success of Halneuron®.
Potential Negatives
- Dogwood Therapeutics is a development-stage biopharmaceutical company, which may indicate a lack of established products or revenue, raising concerns about financial stability.
- The announcement relies heavily on forward-looking statements, which are subject to substantial risks and uncertainties, potentially indicating that the timelines and outcomes could change unpredictably.
- The company acknowledges that there are currently no approved treatments for chronic neuropathy, suggesting a high level of competition and risk in successfully bringing Halneuron® to market.
FAQ
What is the HALT-CINP clinical trial about?
The HALT-CINP trial evaluates Halneuron® for treating chemotherapy-induced neuropathic pain (CINP).
When will the first patient be dosed in the trial?
Dosing of the first patient is expected in the first quarter of 2025.
What is Halneuron®?
Halneuron® is a first-in-class Nav 1.7 sodium channel inhibitor developed for non-opioid pain relief.
What are the anticipated results from the HALT-CINP trial?
Interim data from the trial are expected to be released in the second half of 2025.
What market need does Halneuron® address?
Halneuron® targets the significant unmet medical need in chronic neuropathic pain for cancer patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
ATLANTA, Jan. 21, 2025 (GLOBE NEWSWIRE) --
Dogwood Therapeutics, Inc.
(Nasdaq: DWTX) (the “Company”), a development-stage biopharmaceutical company focused on advancing first-in class, non-opioid, Nav 1.7 inhibitor treatments for chronic and acute pain, announced today that dosing of the first patient in its Phase 2b clinical trial, referred to as HALT-CINP (Halneuron
®
Treatment of Chemotherapy Induced Neuropathic Pain), evaluating Halneuron
®
to treat neuropathic pain associated with prior chemotherapy treatment (“CINP”) is expected to occur in the first quarter of 2025.
Halneuron
®
is a first-in-class, Nav 1.7 specific voltage gated sodium channel inhibitor being developed as an alternative to pain treatment with opioids. Halneuron
®
treated patients demonstrated a statistically significant reduction in cancer-related pain in a previous Phase 2 clinical trial with an acceptable safety profile. Halneuron
®
has been evaluated in over 700 patients in a series of Phase 1 and Phase 2 studies, with no addiction potential.
“Chemotherapy is effective, but can be very challenging for patients given common side effects, including fever, fatigue, infection, hair loss, neuropathy and pain,” commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Dogwood Therapeutics, Inc. “Research suggests that one-in-three patients treated with certain chemotherapeutics including taxanes and platinum drugs develop chronic painful neuropathy. There are currently no approved treatments for chronic neuropathy, and off label treatment with available analgesics is generally not effective. Further, market data suggest that approximately one-in-three cancer patients are treated with opioids.”
“The lead Halneuron
®
target indication in CINP represents an area of high unmet medical need and a market valued at approximately $1.5B,” said Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics, Inc. “The Dogwood executive team has established a track record of developing and/or commercializing blockbuster medicines, including the pain therapeutics Celebrex, Lyrica and Savella.”
About Dogwood Therapeutics
Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary non-opioid, Nav 1.7 analgesic program is centered on our lead development candidate, Halneuron
®
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 CINP. Interim data from the forthcoming Phase 2 CINP study are expected in 2H 2025. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of anti-herpes antivirals and the anti-inflammatory agent, celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia (“FM”) and Long-COVID (“LC”). IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. IMC-2 has been assessed in both active control and double-blind, placebo clinical trials and in both cases demonstrated successful reduction of the fatigue associated with LC. The company has reached an agreement with FDA on using reduction in fatigue as the primary endpoint for future LC research and is currently planning to advance IMC-2 into Phase 2b research.
For more information, please visit
www.dwtx.com
.
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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 and results of current and future clinical studies relating to Dogwood’s product candidates. 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 Amended Annual Report on Form 10-K/A for the year ended December 31, 2023 and the Company’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2024, which are 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.
Contact:
IR@dwtx.com
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