Summary: Dogwood Therapeutics announced that its investigational low-dose IMC-2 antiviral therapy has shown promising results in reducing fatigue and sleep disturbances in patients with long-COVID. The recently completed study found that the low-dose regimen (valacyclovir 750 mg + celecoxib 200 mg twice daily) achieved clinically meaningful improvements compared to placebo, while the high-dose regimen was less effective likely due to increased gastrointestinal side effects. The findings are expected to support the planning of larger-scale phase 2 studies.
Key Takeaways:
- Low-Dose Therapy Shows Efficacy: The low-dose IMC-2 regimen demonstrated a significant reduction in long-COVID-related fatigue and sleep issues, while the high-dose regimen did not show the same benefits.
- Potential for Further Studies: The study’s results provide a basis for advancing IMC-2 into larger, multi-center phase 2 trials aimed at developing effective treatments for long-COVID symptoms.
- Unmet Need in Long-COVID Treatment: As no FDA-approved therapies currently exist for long-COVID, these findings highlight the potential of IMC-2 to address persistent fatigue and sleep disturbances in affected patients.
Dogwood Therapeutics Inc, a development-stage biotechnology company advancing medicines to treat pain and fatigue-related disorders, announced topline data from the recently completed IMC-2 long-COVID study.
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 adverse events associated with the higher dose regimen.
The study was conducted via an investigator-initiated, investigational research grant provided to the Bateman Horne Center (BHC).
“To date, there are no FDA-approved medicines to treat long-COVID symptoms,” says Lucinda Bateman, MD, founder and chief medical officer of the Bateman Horne Center and the study’s principal investigator, in a release. “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.”
IMC-2 Long-COVID Development Program Summary
Completed in 2023, the BHC Study 201 was an 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, 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, the 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 gastrointestinal-related adverse events compared to the low-dose and placebo cohorts.
“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,” says R. Michael Gendreau, MD, chief medical officer of Dogwood Therapeutics Inc, in a release. “IMC-2 demonstrated a robust reduction in fatigue, the primary endpoint agreed with the Food and 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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