IMC-1, a combination treatment of two drugs targeting the herpes virus, may be a safe and effective treatment for patients with fibromyalgia, according to the results of a Phase 2 trial developed by Innovative Med Concepts.
Results were published in an article titled “A Famciclovir + Celecoxib Combination Treatment Is Safe And Efficacious In The Treatment Of Fibromyalgia” in the Journal of Pain Research.
“Infections and other stressors have been implicated in the development of fibromyalgia,” researchers wrote in their report. “We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated … IMC-1, active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.”
The PRID-201 study (NCT01850420) enrolled 143 patients with fibromyalgia at 12 research centers in the U.S. to evaluate the effects of IMC-1 — a combination treatment of the antiviral drug famciclovir and the anti-inflammatory drug celecoxib (brand name Celebrex).
Results showed that, after 16 weeks of treatment, patients receiving IMC-1 had a decrease in fibromyalgia-associated pain compared to patients on a placebo. Half of the patients assigned to receive IMC-1 presented at least a 30% decline in pain, and 38% presented at least a 50% decrease in pain.
IMC-1 treatment also improved the scores of two questionnaires, the Patient Global Impression of Change (PGIC) and the revised disease-specific Fibromyalgia Impact Questionnaire (FIQ-R), as well as the patient’s self-reported fatigue.
IMC-1 was well-tolerated by patients. Common side effects included gastrointestinal (29% vs 42.5% in the placebo group) and nervous system (17.4% vs. 23.3%) events, but these were more frequently seen in patients in the placebo group than in those in the treatment group. Also, most patients adhered to the complete treatment compared to the placebo (82.6% vs. 60.8%).
Taken together, the results showed that suppressing latent herpes viruses may significantly improve fibromyalgia-related symptoms, and that the treatment is a safe and effective approach to reduce pain in this patient population.
Based on several positive results, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to IMC-1 in 2016 to support and accelerate the development of this therapy for those in need.
According to a press release, Innovative Med Concepts plans to conduct a Phase 3 trial using an improved IMC-1 later in 2017.