Dogwood Therapeutics Announces Patient Dosing in Phase 2b Trial Evaluating Halneuron® in Patients with Chemotherapy Induced Neuropathy (CINP) to Commence First Quarter of 2025
Dogwood Therapeutics (NASDAQ: DWTX) announced plans to begin patient dosing in Q1 2025 for its Phase 2b clinical trial (HALT-CINP) evaluating Halneuron®, a first-in-class Nav 1.7 inhibitor for treating chemotherapy-induced neuropathic pain (CINP). The drug has shown promising results in previous trials, demonstrating statistically significant reduction in cancer-related pain with an acceptable safety profile across over 700 patients, and importantly, shows no addiction potential.
The company is targeting a significant unmet medical need, as one-third of patients treated with certain chemotherapeutics develop chronic painful neuropathy, with no currently approved treatments. The CINP market is valued at approximately $1.5B, representing a substantial opportunity for Dogwood Therapeutics.
Dogwood Therapeutics (NASDAQ: DWTX) ha annunciato piani per iniziare la somministrazione ai pazienti nel primo trimestre del 2025 per il suo studio clinico di fase 2b (HALT-CINP) che valuta Halneuron®, un inibitore di Nav 1.7 innovativo per il trattamento del dolore neuropatico indotto da chemioterapia (CINP). Il farmaco ha mostrato risultati promettenti in trial precedenti, dimostrando una riduzione statisticamente significativa del dolore correlato al cancro con un profilo di sicurezza accettabile su oltre 700 pazienti e, soprattutto, non presenta potenziale di dipendenza.
L'azienda mira a soddisfare un'importante esigenza medica insoddisfatta, poiché un terzo dei pazienti trattati con certi chemioterapici sviluppa neuropatia dolorosa cronica, senza trattamenti attualmente approvati. Il mercato CINP è valutato a circa 1,5 miliardi di dollari, rappresentando un'opportunità significativa per Dogwood Therapeutics.
Dogwood Therapeutics (NASDAQ: DWTX) anunció planes para comenzar la administración de pacientes en el primer trimestre de 2025 para su ensayo clínico de fase 2b (HALT-CINP) que evalúa Halneuron®, un inhibidor de Nav 1.7 de primera clase para el tratamiento del dolor neuropático inducido por quimioterapia (CINP). El medicamento ha mostrado resultados prometedores en ensayos anteriores, demostrando una reducción estadísticamente significativa en el dolor relacionado con el cáncer con un perfil de seguridad aceptable en más de 700 pacientes y, lo que es más importante, no muestra potencial de adicción.
La empresa está abordando una necesidad médica no satisfecha significativa, ya que un tercio de los pacientes tratados con ciertos quimioterapéuticos desarrolla neuropatía dolorosa crónica, sin tratamientos actualmente aprobados. El mercado de CINP se valora en aproximadamente 1.5 mil millones de dólares, lo que representa una oportunidad sustancial para Dogwood Therapeutics.
Dogwood Therapeutics (NASDAQ: DWTX)는 화학요법 유도 신경병증(CINP) 치료를 위한 첫 번째 클래스의 Nav 1.7 억제제인 Halneuron®의 2b상 임상 시험(HALT-CINP)에서 환자 대상 투약을 2025년 1분기부터 시작할 계획이라고 발표했습니다. 이 약물은 이전 임상 시험에서 유망한 결과를 보였으며, 700명 이상의 환자에서 암 관련 통증의 통계적으로 유의미한 감소를 보여주었고, 수용 가능한 안전성 프로필을 갖추고 있으며, 중요한 점은 중독 가능성이 없음을 나타냅니다.
회사는 특정 화학요법제 치료를 받은 환자의 3분의 1이 만성 통증성 신경병증을 개발하고 있으며, 현재 승인된 치료가 없기 때문에 상당한 unmet medical need를 목표로 하고 있습니다. CINP 시장은 약 15억 달러로 평가되며, Dogwood Therapeutics에게는 상당한 기회를 나타냅니다.
Dogwood Therapeutics (NASDAQ: DWTX) a annoncé des plans pour commencer l'administration aux patients au premier trimestre de 2025 pour son essai clinique de phase 2b (HALT-CINP) évaluant Halneuron®, un inhibiteur de Nav 1.7 de première classe pour traiter la douleur neuropathique induite par chimiothérapie (CINP). Le médicament a montré des résultats prometteurs lors d'essais précédents, démontrant une réduction statistiquement significative de la douleur liée au cancer avec un profil de sécurité acceptable chez plus de 700 patients et, surtout, ne montre aucun potentiel d'addiction.
L'entreprise cible un besoin médical largement insatisfait, car un tiers des patients traités avec certains chimiothérapeutiques développent une neuropathie douloureuse chronique, sans traitements actuellement approuvés. Le marché de la CINP est évalué à environ 1,5 milliard de dollars, représentant une opportunité substantielle pour Dogwood Therapeutics.
Dogwood Therapeutics (NASDAQ: DWTX) hat Pläne angekündigt, im ersten Quartal 2025 mit der Patientendosierung für seine Phase-2b-Studie (HALT-CINP) zu beginnen, die Halneuron®, einen erstmaligen Nav 1.7-Inhibitor zur Behandlung von chemotherapiebedingten neuropathischen Schmerzen (CINP), evaluiert. Das Medikament hat in früheren Studien vielversprechende Ergebnisse gezeigt und eine statistisch signifikante Reduktion von krebserkrankungsbedingten Schmerzen bei einem akzeptablen Sicherheitsprofil in über 700 Patienten demonstriert und zeigt zudem kein Suchtpotential.
Das Unternehmen zielt auf einen erheblichen nicht erfüllten medizinischen Bedarf ab, da ein Drittel der Patienten, die mit bestimmten Chemotherapeutika behandelt werden, an chronischer schmerzhafter Neuropathie leidet, ohne dass derzeit zugelassene Behandlungen existieren. Der CINP-Markt wird auf etwa 1,5 Milliarden US-Dollar geschätzt, was eine erhebliche Möglichkeit für Dogwood Therapeutics darstellt.
- Previous Phase 2 trial showed statistically significant reduction in cancer-related pain
- Safety profile validated across 700+ patients with no addiction potential
- Targeting $1.5B market opportunity in CINP
- Addresses unmet medical need with no currently approved treatments
- Phase 2b trial not starting until Q1 2025
- Still in development stage with no approved products
Insights
The initiation of Phase 2b trials for Halneuron® represents a important milestone in addressing the significant unmet need in chemotherapy-induced neuropathic pain (CINP). The previous Phase 2 results showing statistically significant pain reduction, combined with safety data from 700+ patients and no addiction potential, positions this Nav 1.7 inhibitor as a promising non-opioid alternative.
The market opportunity is compelling - with one-third of chemotherapy patients developing chronic painful neuropathy and a similar proportion currently relying on opioids. This translates to a substantial addressable market of
Key differentiators include:
- First-in-class Nav 1.7 specific mechanism
- Non-addictive profile
- Robust safety database
- Strong preliminary efficacy signals
For a simpler explanation: Think of nerve pain like a faulty electrical circuit that won't stop firing. Current treatments are like trying to fix it with duct tape - they might help temporarily but aren't solving the real problem. Halneuron® is designed to specifically target and "turn down" the problematic circuit without affecting other important nerve functions.
This Phase 2b trial initiation signals strong commercial potential for DWTX. With a market cap of
The current standard of care relies heavily on opioids, creating an attractive market entry point for a non-addictive alternative. The lack of approved treatments for CINP presents minimal competitive barriers and potential for premium pricing. Key value drivers include:
- Large addressable market with clear unmet need
- Potential first-mover advantage
- Strong IP position as first-in-class therapy
- Experienced management team
In simpler terms: Imagine entering a market where customers desperately need your product, there's no real competition and you have the best team to sell it. That's essentially what Dogwood is doing with Halneuron®.
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
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.
Follow Dogwood Therapeutics
Email Alerts: https://ir.dwtx.com/resources/email-alerts
LinkedIn: https://www.linkedin.com/company/dogwoodther/
Twitter: https://twitter.com/dogwoodther
Facebook: https://www.facebook.com/dogwoodther
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
FAQ
When will Dogwood Therapeutics (DWTX) begin Phase 2b trial dosing for Halneuron?
How many patients have been treated with Halneuron in previous clinical trials?
What is the market size for chemotherapy-induced neuropathic pain that DWTX is targeting?
What percentage of chemotherapy patients develop chronic painful neuropathy?
Does Halneuron show addiction potential in clinical trials?
