celecoxib/famciclovir (IMC-1) / Virios Therap - LARVOL DELTA

FORTRESS: Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1 (clinicaltrials.gov) - P2b | N=422 | Completed | Sponsor: Virios Therapeutics, Inc. | Active, not recruiting ➔ Completed

HEOR • Trial completion • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

FORTRESS: Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1 (clinicaltrials.gov) - P2b | N=460 | Active, not recruiting | Sponsor: Virios Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • HEOR • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

[VIRTUAL] The Safety of IMC-1 in Patients With Fibromyalgia: Phase 2a Study Results (IASP 2021) - "Predefined rescue therapy (tramadol prescribed as rescue) for acute exacerbations of pain was used at least once by significantly more placebo-treated patients (41.1%) than ICM-1 patients (24.6%) (P=.0372). IMC-1 was unusually well tolerated in patients with FM as shown by higher overall completion rates and lower rates of discontinuation due to AEs for IMC-1 versus placebo-treated patients. AEs that were reported more frequently in IMC-1-treated patients appeared to be consistent with the known safety profiles of celecoxib and famciclovir. There was no evidence of additional safety signals resulting from the combined use of celecoxib and famciclovir at the doses studied."

Clinical • P2a data • Alzheimer's Disease • Breast Cancer • Cardiovascular • Cognitive Disorders • Dermatology • Fatigue • Fibromyalgia • Gastroenterology • Gastrointestinal Disorder • Herpes Simplex • Infectious Disease • Musculoskeletal Pain • Myocardial Infarction • Nephrology • Oncology • Pain • Rheumatology • Solid Tumor

[VIRTUAL] IMC-1, A FIXED DOSE COMBINATION OF FAMCICLOVIR AND CELECOXIB, IMPROVES COMMON SYMPTOMS ASSOCIATED WITH FIBROMYALGIA IN ADDITION TO PAIN: POST HOC ANALYSIS OF A PHASE 2A TRIAL (EULAR 2021) - "In addition to alleviation of chronic pain, treatment with IMC-1 appears to be effective in improving many of the other symptoms often associated with fibromyalgia. Further clinical trials are warranted."

P2a data • Retrospective data • Depression • Fatigue • Fibromyalgia • Herpes Simplex • Mood Disorders • Musculoskeletal Pain • Pain • Psychiatry • Rheumatology • Sleep Disorder

Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1 (clinicaltrials.gov) - P2b; N=460; Recruiting; Sponsor: Virios Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • HEOR • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Virios Therapeutics to Present at the H.C. Wainwright Global Life Sciences Conference in March 2021 (Businesswire) - "Virios Therapeutics...will present a company overview at the H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 - 10, 2021...The presentation will focus on the need for new approaches to treat fibromyalgia ('FM'), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial."

Trial status • Fibromyalgia • Musculoskeletal Diseases • Pain

A Phase 2b Study To Evaluate The Efficacy And Safety Of IMC-1 BID In Patients With Fibromyalgia (clinicaltrials.gov) - P2b; N=460; Not yet recruiting; Sponsor: Virios Therapeutics, Inc.

Clinical • New P2b trial • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology