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Safety Data from Phase 2a Trial of IMC-1 Presented at IASP
On June 9, 2021, Virios Therapeutics, Inc. (NASDAQ:VIRI) announced a poster presentation at the International Association for the Study of Pain (IASP) World Congress showing that IMC-1 was better tolerated than placebo in fibromyalgia (FM) patients in the company’s Phase 2a clinical trial. A copy of the poster can be accessed here.
The following figure shows the total discontinuation rates, discontinuations due to adverse events (AEs), discontinuations due to therapeutic failure, and the use of rescue mediation from the Phase 2a trial. A greater percentage of patients in the placebo group discontinued treatment before the end of the study compared to patients in the IMC-1 group. Patients in the placebo group discontinued due to AEs at a nearly 3-fold higher rate than patients in the IMC-1 group (P=0.012). Lastly, the use of tramadol rescue medication was also significantly lower in the IMC-1 group compared to the placebo group (P=0.037).
The following table summarizes the most commonly reported treatment emergent AEs (TEAEs) for placebo and IMC-1 treated patients. TEAEs were reported by 72.5% of patients treated with IMC-1 and 78.1% of placebo-treated patients. There were no deaths reported during the study, and serious AEs were reported by one patient in the placebo group (breast cancer) and two patients in the IMC-1 group (cellulitis, acute myocardial infarction). The breast cancer and cellulitis cases were deemed unrelated to treatment with the acute myocardial infarction deemed possibly related to treatment, however that patient had underlying coronary artery disease and a strong family history of premature cardiac disease.
Lastly, the rate of gastrointestinal (GI) TEAEs was higher in the placebo group compared to the IMC-1 group. The following figure shows that the overall incidence of GI TEAEs was higher in the placebo group (42.5%) compared to the IMC-1 group (29.0%), along with the reported incidence of diarrhea, nausea, and vomiting.
First Patient Dosed in Phase 2b Trial
On June 4, 2021, Virios announced the first patient was dosed in the Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1) trial evaluating IMC-1 in patients with FM. It is a randomized, double blind, placebo controlled, multi-center trial with a primary endpoint of reduction in pain and secondary endpoints including change in fatigue, sleep disturbance, global health status, and patient functionality. Approximately 460 females between the ages of 18-65 will be enrolled with a study duration of 16 weeks. An outline of the trial is shown below and we anticipate topline results in mid-2022.
The safety data from the Phase 2a trial shows that in addition to IMC-1 exhibiting a significant impact on reducing pain in FM patients, the drug is very well tolerated, which could lead to a high uptake by patients and prescribers (if the drug is approved) as the current FM therapies have a number of intolerable side effects. We are glad to see that the company has initiated the Phase 2b trial according to the previously disclosed timeline, and we look forward to topline results in mid-2022. With no changes to our model our valuation remains at $22 per share.
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