By David Bautz, PhD
NASDAQ:VIRI
READ THE FULL VIRI RESEARCH REPORT
Business Update
Encouraging Results in Open Label Trial of IMC-2 in Long COVID
On July 17, 2023, Virios Therapeutics, Inc. (NASDAQ:VIRI) announced results from the open label, proof-of-concept trial of IMC-2 (combination of valacyclovir and celecoxib) for the treatment of Post-Acute Sequelae of COVID-19 infection (PASC), otherwise known as Long COVID. The results of the trial showed that patients experienced clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction following 14 weeks of treatment when compared to a control cohort of Long COVID patients matched by age, gender, length of illness, and treated with routine care.
The open label, single center, investigator-initiated study was conducted at the Bateman Horne Center with an unrestricted investigational grant provided by Virios. A total of 39 females were enrolled in the trial and 37 (N=20 for treatment group; N=17 for control group) completed the study. The following graph shows the results for the primary endpoint, which was the change in PROMIS Fatigue T-Score from baseline. Results show that those treated› with IMC-2 (Val/Cel) experienced a mean change of -7.24 compared to a change of only -0.34 for the control group (P=0.008). In speaking with management, it is generally recognized that a decrease of 3.0 or greater on the PROMIS score will have a noticeable effect for the patient.
An exploratory endpoint for the study examined the effect on orthostatic intolerance, which is seen both in patients with Long COVID as well as chronic fatigue syndrome. The following charts show that treatment with IMC-2 improved both orthostatic symptoms as well as orthostatic activity limitations.
In summary, treatment of Long COVID patients in this trial resulted in positive results for all of the following outcomes examined, with the exception of the HADS Depression Scale that did not reach statistical significance. What makes these results all the more impressive is that this study was merely an exploratory trial and was not powered to show statistical significance. Thus, the fact that so many outcomes reached statistical significance is highly encouraging and justifies expanding the study of IMC-2 for the treatment of Long COVID. In addition, IMC-2 was well tolerated as there were no serious adverse events and the side effect profile was consistent with what is known for both valacyclovir and celecoxib.
With these results in hand, we anticipate Virios meeting with the FDA to map out a path forward for IMC-2 for the treatment of Long COVID and what that will entail. We are hopeful the company will be in a position to provide an update before the end of 2023.
Conclusion
The results for the proof-of-concept Long COVID study are very encouraging and we look forward to an update from the company regarding next steps after it is able to meet with the FDA. Long COVID is estimated to affect approximately 65 million people worldwide, thus representing an enormous potential market opportunity. We have added the treatment of Long COVID with IMC-2 into our valuation model, which has increased our valuation to $3.50 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.