IMC currently has 9 compounds in its pipeline, treating a wide range of related conditions. Spearheading IMC’s efforts is IMC-1, a novel fixed-dose combination oral medication designed to treat chronic tissue-resident herpes simplex virus type 1 (HSV-1), a condition that may be one of the underlying causes of fibromyalgia.
IMC-1 achieved a milestone with the recent completion of the Fibromyalgia Anti-viral Suppression Trial (The “FAST” Study): a double-blind, placebo-controlled phase 2 proof-of-concept trial in fibromyalgia (N=143). Patients randomized from 12 US sites were diagnosed with primary fibromyalgia as defined by the 2010 College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia. They were evaluated at various intervals for 16 weeks.
Results were released November 17, 2014, during an oral presentation at the American College of Rheumatology Annual Meeting. IMC is currently working with the FDA to meet all the necessary requirements to start the IMC-1 phase 3 trials for the management of fibromyalgia.
The United States Patent and Trademark Office (USPTO) issued a Composition of Matter Patent for IMC-1 (famciclovir and celecoxib) and a Method of Use Patent for the treatment of fibromyalgia, chronic fatigue syndrome, and IBS. Additional patents have been issued or allowed for IMC-1 in Europe (validated in 18 major EU countries), Japan, and Australia. All patents expire February 2033. Additional patents are pending through accelerated examination, representing over 90% of the world Pharma market.
In January 2016, IMC-1 was granted Fast Track designation by the FDA. In order to receive Fast Track designation, a product must demonstrate the potential to address an unmet medical need in a serious condition. Companies granted Fast Track designation benefit from greater access to, and more frequent communications with, the FDA throughout the drug development or review process and are allowed to submit New Drug Applications (NDAs) on a rolling basis. In addition, Fast Track designation products are eligible for potential accelerated approval and priority reviews.
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