Dogwood Therapeutics Announces Dosing of First Patient in Phase 2b Trial Evaluating Halneuron® in Patients with Chemotherapy-Induced Neuropathic Pain
Dogwood Therapeutics (NASDAQ: DWTX) has initiated dosing in its Phase 2b clinical trial (HALT-CINP) evaluating Halneuron® for chemotherapy-induced neuropathic pain (CINP). The drug targets the NaV 1.7 sodium channel and represents a potential opioid-free, addiction-free treatment for the $1.5B worldwide CINP market.
Halneuron® has demonstrated promising results in previous trials, showing statistically significant reduction in cancer-related pain with an acceptable safety profile. The drug has been tested in over 700 patients across Phase 1 and 2 studies, showing no addiction potential.
The company aims to recruit 100 CINP patients by Q4 2025, with an interim analysis planned for the same quarter. The adaptive trial design allows for potential study modifications to optimize outcomes.
Dogwood Therapeutics (NASDAQ: DWTX) ha avviato la somministrazione nel suo studio clinico di fase 2b (HALT-CINP) che valuta Halneuron® per il dolore neuropatico indotto da chemioterapia (CINP). Il farmaco agisce sul canale sodico NaV 1.7 e rappresenta un potenziale trattamento privo di oppioidi e di dipendenza per il mercato globale del CINP, che vale 1,5 miliardi di dollari.
Halneuron® ha mostrato risultati promettenti in studi precedenti, evidenziando una riduzione statisticamente significativa del dolore correlato al cancro con un profilo di sicurezza accettabile. Il farmaco è stato testato su oltre 700 pazienti in studi di fase 1 e 2, senza evidenziare potenziale di dipendenza.
L'azienda mira a reclutare 100 pazienti con CINP entro il quarto trimestre del 2025, con un'analisi intermedia prevista per lo stesso trimestre. Il design adattivo dello studio consente modifiche potenziali per ottimizzare i risultati.
Dogwood Therapeutics (NASDAQ: DWTX) ha iniciado la dosificación en su ensayo clínico de fase 2b (HALT-CINP) que evalúa Halneuron® para el dolor neuropático inducido por quimioterapia (CINP). El fármaco se dirige al canal de sodio NaV 1.7 y representa un tratamiento potencial libre de opioides y adicciones para el mercado mundial de CINP, que asciende a 1.5 mil millones de dólares.
Halneuron® ha demostrado resultados prometedores en ensayos anteriores, mostrando una reducción estadísticamente significativa del dolor relacionado con el cáncer con un perfil de seguridad aceptable. El fármaco ha sido probado en más de 700 pacientes en estudios de fase 1 y 2, sin mostrar potencial de adicción.
La empresa tiene como objetivo reclutar 100 pacientes con CINP para el cuarto trimestre de 2025, con un análisis intermedio planeado para el mismo trimestre. El diseño adaptativo del ensayo permite modificaciones potenciales para optimizar los resultados.
Dogwood Therapeutics (NASDAQ: DWTX)는 화학요법 유도 신경병증 통증(CINP)을 평가하는 2b상 임상 시험(HALT-CINP)에서 Halneuron®의 투여를 시작했습니다. 이 약물은 NaV 1.7 나트륨 채널을 표적으로 하며, 15억 달러 규모의 전 세계 CINP 시장을 위한 오피오이드와 중독이 없는 잠재적 치료법을 나타냅니다.
Halneuron®은 이전 임상 시험에서 유망한 결과를 보여주었으며, 암 관련 통증에서 통계적으로 유의미한 감소를 나타내고 수용 가능한 안전성 프로필을 보였습니다. 이 약물은 1상 및 2상 연구에서 700명 이상의 환자를 대상으로 시험되었으며, 중독 가능성은 없었습니다.
회사는 2025년 4분기까지 100명의 CINP 환자를 모집할 계획이며, 같은 분기에 중간 분석을 계획하고 있습니다. 적응형 시험 설계는 결과를 최적화하기 위한 연구 수정 가능성을 허용합니다.
Dogwood Therapeutics (NASDAQ: DWTX) a lancé la dosification dans son essai clinique de phase 2b (HALT-CINP) évaluant Halneuron® pour la douleur neuropathique induite par chimiothérapie (CINP). Le médicament cible le canal sodique NaV 1.7 et représente un traitement potentiel sans opiacés et sans dépendance pour le marché mondial du CINP, évalué à 1,5 milliard de dollars.
Halneuron® a montré des résultats prometteurs lors d'essais précédents, avec une réduction statistiquement significative de la douleur liée au cancer et un profil de sécurité acceptable. Le médicament a été testé sur plus de 700 patients dans des études de phase 1 et 2, sans potentiel de dépendance.
L'entreprise vise à recruter 100 patients CINP d'ici le quatrième trimestre 2025, avec une analyse intermédiaire prévue pour le même trimestre. La conception adaptative de l'essai permet des modifications potentielles pour optimiser les résultats.
Dogwood Therapeutics (NASDAQ: DWTX) hat die Dosierung in seiner Phase-2b-Studie (HALT-CINP) zur Bewertung von Halneuron® bei chemotherapiebedingten neuropathischen Schmerzen (CINP) initiiert. Das Medikament zielt auf den NaV 1.7 Natriumkanal ab und stellt eine potenzielle Behandlung ohne Opioide und ohne Sucht für den weltweiten CINP-Markt im Wert von 1,5 Milliarden Dollar dar.
Halneuron® hat in früheren Studien vielversprechende Ergebnisse gezeigt und eine statistisch signifikante Reduktion der krebsbedingten Schmerzen bei akzeptablem Sicherheitsprofil erzielt. Das Medikament wurde in über 700 Patienten in Phase-1- und Phase-2-Studien getestet, ohne Anzeichen einer Suchtgefahr.
Das Unternehmen plant, bis zum vierten Quartal 2025 100 CINP-Patienten zu rekrutieren, wobei eine Zwischenanalyse für dasselbe Quartal vorgesehen ist. Das adaptive Studiendesign ermöglicht potenzielle Modifikationen, um die Ergebnisse zu optimieren.
- Previous Phase 2 trials showed statistically significant pain reduction
- No addiction potential observed in 700+ patients
- Targeting $1.5B worldwide CINP market
- Successfully initiated Phase 2b trial with first patient dosed
- Final trial results not expected until after Q4 2025
- May require study modifications based on interim analysis
Opioid-free and addiction-free pain treatment therapy could address
ATLANTA, March 18, 2025 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (“Dogwood” or the “Company”), a development-stage biopharmaceutical company focused on advancing first-in-class, non-opioid, treatments for chronic and acute pain, announces the 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® for the treatment of neuropathic pain associated with prior chemotherapy treatment (“CINP”).
“Halneuron® is being developed to specifically inhibit the NaV 1.7 sodium channel, given the well-established role of this target in pain transmission,” said Greg Duncan, Dogwood’s Chairman and Chief Executive Officer. “We believe Halneuron’s® inherent specificity and potency may enable physicians to use very low doses of Halneuron® to both reduce pain and minimize the off-target effects that have limited prior NaV 1.7 development candidates.”
Halneuron® is a first-in-class, NaV 1.7 specific voltage gated sodium channel inhibitor being developed as an alternative to chronic pain treatment with opioids. Patients treated with Halneuron® 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 and shows no signs of addiction potential.
“Our goal is to recruit 100 patients with CINP by the fourth quarter of 2025, which should allow us to execute an interim analysis on the HALT-CINP trial in the fourth quarter of 2025,” commented R. Michael Gendreau, M.D., Ph.D., Dogwood’s Chief Medical Officer. “This proposed interim analysis will inform our adaptive trial design, enabling changes to the study, if necessary, to improve trial outcomes.”
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 the second half of 2025.
Dogwood’s 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-controlled 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.
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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.
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