Dogwood Therapeutics, Inc. (DWTX), a development-stage biotechnology company, announced on Monday the top-line data from the recently completed BHC IMC-2 Long-COVID study.
According to the company, IMC-2 treatment, dosed as valacyclovir 750 mg + celecoxib 200 mg twice daily, demonstrated a clinically meaningful reduction in long-term COVID-related fatigue and sleep disturbance as compared to placebo.
The study was conducted via an investigator-initiated, investigational research grant provided to the Bateman Horne Center.
"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."
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