IMC-1 is an investigational drug by Innovative Med Concepts (IMC) that is being studied for the treatment of fibromyalgia.
Fibromyalgia (FM) is a chronic disorder with symptoms that include chronic pain, fatigue, headaches, sleeping problems, mood changes and inability to concentrate. People with FM have a problem with central pain processing. Although the exact causes of the condition are unknown, it is thought to be due to a combination of genetic and environmental factors. Other potential causes that may trigger FM include, physical trauma, infections, emotional distress, endocrine disorders and immune activation.
IMC-1 is a fixed dose combination drug with proprietary doses of famciclovir, an anti-viral nucleoside analog, which prevents viral replication, and the anti-inflammatory compound celecoxib , which also processes unique anti-viral activity. The mechanism of action of IMC-1 is to suppress chronic tissue-resident herpes virus (HSV-1), interrupting the cyclical processes of virus reactivation and lytic infection, which may have a role in triggering and/or maintaining symptoms of FM.
IMC-1 clinical studies
A Phase 2 clinical trial testing IMC-1 has been completed successfully (NCT01850420, known as PRID-201). In this randomized, double-blinded, placebo-controlled, proof-of-concept study, the drug was evaluated for its efficacy and safety. A total of 143 female participants with FM, from different sites across the U.S., received either IMC-1 or a placebo. Researchers measured the participants’ pain scores over a 16-week treatment period using two questionnaires: The Patient Global Impression of Change (PGIC), and the revised disease-specific Fibromyalgia Impact Questionnaire (FIQ-R).
Results, first announced at the 2014 American College of Rheumatology annual meeting and published in the Journal of Pain Research, showed that after the 16-week treatment period, patients taking ICM-1 had a decrease in fibromyalgia-associated pain, and improved scores on the two questionnaires. There also was a decrease in patients’ self-reported fatigue levels. The drug was well-tolerated and safe.
These results suggest that IMC-1 could be a promising new option for the treatment of pain and other symptoms of FM, as well as for other conditions, such as irritable bowel syndrome (IBS), myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), chronic neck and back pain and cognitive impairment, as well as a broad range of other conditions that share the same underlying physiologic processes. Overall, the study showed that suppressing the latent herpes virus (HSV-1) is able to significantly improve FM symptoms.
Common side effects of IMC-1 include adverse events affecting the digestive tract and nervous system. However, during the Phase 2 trial these were seen more frequently in the placebo group, suggesting that they may not be caused directly by the drug.
In January 2016, IMC-1 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation is designed to facilitate the development and expedite the review of drugs to treat serious diseases for which there is an unmet medical need.
IMC-1 has been issued a Composition of Matter Patent and a Method of Use Patent for the treatment of FM, CFS and IBS, in the U.S. Other patents also have been issued or allowed for IMC-1 in Europe, Japan and Australia.
Currently, IMC is working to start a Phase 3 randomized, double-blinded, multi-center, factorial pivotal trial, using an improved version of IMC-1. The trial is expected to start at the end of 2017.
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