Dogwood Therapeutics, Inc. Announces Low Dose IMC-2 Treatment Reduces Long-COVID Related Fatigue and Sleep Disturbance in an Investigator-Initiated Study

– 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 (TASE:) 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…