Dogwood Therapeutics, Inc. Announces Low Dose IMC-2 Treatment Reduces Long-COVID Related Fatigue and Sleep Disturbance in an Investigator-Initiated Study
Dogwood Therapeutics (NASDAQ: DWTX) announced positive top-line data from their BHC IMC-2 Long-COVID study. The low-dose combination of valacyclovir 750 mg + celecoxib 200 mg twice daily showed clinically meaningful reductions in Long-COVID related fatigue and sleep disturbance compared to placebo. The higher dose (valacyclovir 1500 mg) was less effective due to GI adverse events. The study's results will inform the design of a planned Phase 2 study with approximately 200 participants. The company also has two other assets: Halneuron® in Phase 2b for chemotherapy-induced neuropathic pain and IMC-1 which is Phase 3-ready for fibromyalgia.
Dogwood Therapeutics (NASDAQ: DWTX) ha annunciato dati preliminari positivi dal loro studio BHC IMC-2 sul Long-COVID. La combinazione a basso dosaggio di valaciclovir 750 mg + celecoxib 200 mg assunta due volte al giorno ha mostrato riduzioni clinicamente significative nella stanchezza e nei disturbi del sonno associati al Long-COVID rispetto al placebo. La dose più alta (valaciclovir 1500 mg) è risultata meno efficace a causa di eventi avversi gastrointestinali. I risultati dello studio informeranno la progettazione di uno studio di Fase 2 pianificato con circa 200 partecipanti. L'azienda ha anche altri due asset: Halneuron® in Fase 2b per il dolore neuropatico indotto da chemioterapia e IMC-1, che è pronto per la Fase 3 per la fibromialgia.
Dogwood Therapeutics (NASDAQ: DWTX) anunció datos preliminares positivos de su estudio BHC IMC-2 sobre Long-COVID. La combinación de bajo dosificación de valaciclovir 750 mg + celecoxib 200 mg dos veces al día mostró reducciones clínicamente significativas en la fatiga y los trastornos del sueño relacionados con Long-COVID en comparación con el placebo. La dosis más alta (valaciclovir 1500 mg) fue menos efectiva debido a eventos adversos gastrointestinales. Los resultados del estudio informarán el diseño de un estudio de Fase 2 planificado con aproximadamente 200 participantes. La empresa también tiene otros dos activos: Halneuron® en Fase 2b para el dolor neuropático inducido por quimioterapia e IMC-1, que está listo para Fase 3 para la fibromialgia.
Dogwood Therapeutics (NASDAQ: DWTX)는 Long-COVID 연구 BHC IMC-2의 긍정적인 최종 결과를 발표했습니다. 낮은 용량의 발라시클로비르 750 mg + 셀레콕시브 200 mg를 하루 두 번 복용했을 때 Long-COVID와 관련된 피로와 수면 장애의 임상적으로 의미 있는 감소가 있었습니다. 높은 용량(발라시클로비르 1500 mg)은 위장 관련 부작용으로 인해 효과가 떨어졌습니다. 연구 결과는 약 200명의 참여자가 포함된 예정된 2상 연구 설계에 정보를 제공할 것입니다. 회사는 또한 두 개의 다른 자산을 보유하고 있습니다: 화학요법 유발 신경통을 위한 2b상 Halneuron®과 섬유근육통에 대해 3상 준비가 완료된 IMC-1입니다.
Dogwood Therapeutics (NASDAQ: DWTX) a annoncé des résultats préliminaires positifs de son étude BHC IMC-2 sur le Long-COVID. La combinaison à faible dose de valaciclovir 750 mg + célécoxib 200 mg deux fois par jour a montré des réductions cliniquement significatives de la fatigue et des troubles du sommeil liés au Long-COVID par rapport au placebo. La dose plus élevée (valaciclovir 1500 mg) s'est avérée moins efficace en raison d'effets indésirables gastro-intestinaux. Les résultats de l'étude permettront d'informer la conception d'une étude de Phase 2 prévue avec environ 200 participants. L'entreprise dispose également de deux autres actifs : Halneuron® en Phase 2b pour la douleur neuropathique induite par la chimiothérapie et IMC-1, qui est prêt pour la Phase 3 pour la fibromyalgie.
Dogwood Therapeutics (NASDAQ: DWTX) hat positive Zwischenergebnisse aus ihrer BHC IMC-2 Long-COVID-Studie bekannt gegeben. Die Kombination aus Valaciclovir 750 mg + Celecoxib 200 mg zweimal täglich zeigte klinisch relevante Reduktionen der mit Long-COVID verbundenen Müdigkeit und Schlafstörungen im Vergleich zu Placebo. Die höhere Dosis (Valaciclovir 1500 mg) war aufgrund von gastrointestinalen Nebenwirkungen weniger wirksam. Die Ergebnisse der Studie werden das Design einer geplanten Phase-2-Studie mit etwa 200 Teilnehmern beeinflussen. Das Unternehmen hat außerdem zwei weitere Produkte: Halneuron® in Phase 2b für chemotherapiebedingte neuropathische Schmerzen und IMC-1, das bereit für Phase 3 für Fibromyalgie ist.
- Low-dose IMC-2 demonstrated clinically meaningful reduction in Long-COVID symptoms
- Results enable progression to larger Phase 2 study with ~200 participants
- FDA Fast Track Designation granted for two pipeline products
- Multiple advanced-stage assets in development pipeline
- High-dose IMC-2 showed increased GI adverse events
- Study results not statistically significant due to small sample size
- Phase 3 program for IMC-1 requires external partnership to proceed
Insights
The BHC IMC-2 Long-COVID study results represent a significant development in treating Long-COVID symptoms, particularly fatigue and sleep disturbances. The low-dose combination (valacyclovir 750mg + celecoxib 200mg twice daily) showed meaningful clinical benefits, while the higher dose was by GI side effects.
Key insights for investors: 1) This positions DWTX strategically in the untapped Long-COVID market with no current FDA-approved treatments, 2) The data provides important parameters for the planned Phase 2 study with ~200 participants, increasing probability of success, 3) The company's pipeline diversity with Halneuron® (CINP) and IMC-1 (fibromyalgia) provides multiple value drivers.
The favorable safety profile of the low-dose regimen and demonstrated efficacy create a compelling path forward for IMC-2's development. However, investors should note that larger scale studies are still needed for FDA approval.
This development significantly strengthens DWTX's market position in the expanding Long-COVID therapeutics space. With an estimated 65 million people globally affected by Long-COVID, the market opportunity is substantial. The positive efficacy signals and manageable safety profile at lower doses present a compelling commercial case.
The company's diversified pipeline reduces investment risk, with three distinct programs targeting different high-value markets: Long-COVID (IMC-2), chemotherapy-induced neuropathic pain (Halneuron®) and fibromyalgia (IMC-1). The FDA Fast Track designations for two programs could accelerate potential market entry and enhance market positioning.
- IMC-2 treatment, dosed as valacyclovir 750 mg + celecoxib 200 mg twice daily, demonstrated clinically meaningful reduction in Long-COVID related fatigue and sleep disturbance as compared to placebo –
- Top-line results from the Bateman Horne Center’s Long-COVID study provide key insights into final design of Dogwood’s planned Phase 2 study, projected to enroll approximately 200 participants -
ATLANTA, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), a development-stage biotechnology company advancing new medicines to treat pain and fatigue-related disorders, today announced top line data from the recently completed BHC IMC-2 Long-COVID study. The study was conducted via an investigator-initiated, investigational research grant provided to the Bateman Horne Center (“BHC”). The study demonstrated that the low dose combination antiviral therapy IMC-2 treated patient cohort (valacyclovir 750 mg + celecoxib dosed 200 mg twice daily) exhibited clinically meaningful reductions in Long-COVID associated fatigue and sleep disturbance, as compared with the placebo treated cohort. The high dose IMC-2 treated cohort (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) did not exhibit clinically meaningful differences versus placebo, believed to be related to higher levels of gastrointestinal (GI) adverse events associated with the higher dose regimen.
“To date, there are no FDA approved medicines to treat Long-COVID symptoms,” said Lucinda Bateman, MD, Founder and Chief Medical Officer of the Bateman Horne Center and the study’s principal investigator. “This trial provides evidence that IMC-2 has the potential to improve fatigue and sleep symptoms associated with Long-COVID illness on a scale not previously observed in Long-COVID research. I believe this finding warrants further investigation of IMC-2 in larger scale, multi-center Long-COVID studies.”
“The primary goals of this trial were to determine the IMC-2 treatment effect size versus placebo and the associated patient sample size to design our planned IMC-2 Phase 2 Long-COVID study in a manner that maximizes probability of success,” said R. Michael Gendreau, MD, Chief Medical Officer of Dogwood Therapeutics, Inc. “IMC-2 demonstrated a robust reduction in fatigue, the primary endpoint agreed with the Food & Drug Administration to advance IMC-2 into Phase 2 development. We look forward to finalizing these plans and providing further information on next steps in the coming months.”
IMC-2 Long-COVID Development Program Summary:
BHC Study 201: Investigator-initiated, open-label, matched control study assessing IMC-2 treatment versus patients matched by age, duration of effect, vaccination status and gender. In this study, completed in 2023, the combination of valacyclovir and celecoxib exhibited statistically significant reductions in Long-COVID related fatigue, orthostatic intolerance, pain and anxiety, while improving overall patient health. The dosage used in this study was valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily.
BHC Study 202: This recently completed study was designed as an investigator-initiated, double-blinded, placebo controlled follow-on study to BHC 201. While not statistically significant given the small sample size recruited for this trial (14-15 per group), the study demonstrated that the low dose combination antiviral therapy IMC-2 exhibited clinically meaningful improvements in fatigue and sleep disruption as compared to placebo treated patients. Overall, the IMC-2 adverse event profile was favorable in this study. The high dose IMC-2 treatment (valacyclovir 1500 mg + celecoxib 200 mg dosed twice daily) resulted in more GI related adverse events compared to the low dose and placebo cohorts.
Additional Assets in Dogwood Therapeutics Proprietary Pipeline:
- Halneuron® is in Phase 2b development as a non-opioid, Nav 1.7 inhibitor to treat the neuropathic pain resultant from chemotherapy treatment. Halneuron® has been granted Fast Track Designation from the FDA for the treatment of Chemotherapy-Induced Neuropathic Pain (CINP).
Next milestone: Interim data from the ongoing Phase 2 CINP study are expected in the second half of 2025.
- IMC-1 (famciclovir + celecoxib) is Phase 3 development ready as a combination antiviral treatment for fibromyalgia (FM). IMC-1 has been granted fast track designation by the FDA as a treatment for FM.
Next milestone: Dogwood is exploring partnerships for IMC-1 to execute the Phase 3 FM program as agreed with the FDA.
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 lead development candidate, Halneuron® which is a voltage-gated sodium channel blocker, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and 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 nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib, for the treatment of illnesses believed to be related to reactivation of previously dormant herpes viruses, including FM and LC. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. 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.
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FAQ
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