TUSCALOOSA, Ala., March 7, 2017 /PRNewswire/ -- Innovative Med Concepts, a developer of novel pharmaceutical products for the treatment of fibromyalgia, irritable bowel syndrome, chronic fatigue, and related conditions, today announced that the Journal of Pain Research published the key topline results from the Phase 2 PRID-201 trial of IMC-1 for the treatment of fibromyalgia (Journal of Pain Research 2017:10 451-460).
This 16 week, randomized double-blinded, placebo-controlled study was conducted at 12 research centers in the United States and enrolled 143 patients with fibromyalgia, as defined by the ACR 2010 criteria. The PRID-201 study demonstrated that patients randomized to IMC-1 (celecoxib+famciclovir) experienced a significant decrease in fibromyalgia-related pain vs patients randomized to placebo. Over 50% of the IMC-1 patients had at least a 30% reduction of pain and 38% of them achieved at least a 50% reduction in pain during the study. Patient global impression of change (PGIC) and the revised disease specific fibromyalgia impact questionnaire (FIQ-R) response rates were also significantly improved. Additionally, IMC-1 significantly improved self-reported fatigue, as measured by the NIH developed PROMIS fatigue inventory. Essentially all primary endpoints and most of the secondary endpoints met statistical significance in the PRID201 Trial.
The safety profile was very encouraging. Despite the celecoxib component of IMC-1, common gastrointestinal (29.0% vs 42.5%) and nervous system (17.4% vs 23.3%) treatment emergent adverse events were reported less frequently in the IMC-1 group than in the placebo treated group. Overall, Study completion rates favored IMC-1 (82.6% vs 60.8%), showing a positive impact on adherence to therapy.
The results of this study suggest that IMC-1 is safe and efficacious in the treatment of the symptoms of fibromyalgia. Based on a novel mechanism of action and the study results showing efficacy on a range of important outcome measures, improved retention rates, decreased adverse event rates, IMC-1 may represent an effective and differentiated treatment for fibromyalgia sufferers.
After completion of the PRID-201 trial, the FDA granted IMC-1 fast track status, finding that FM is a serious disease with a large unmet need and that IMC-1 has the potential to meet that need. IMC plans to start a Phase 3 randomized, double-blinded, multi-center, factorial pivotal trial, using an improved IMC-1, later this year.
About Innovative Med Concepts
Innovative Med Concepts, LLC, is a biotech company developing novel treatments for fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), irritable bowel syndrome and other related conditions. On the Web: http://innovativemedconcepts.com.
Forward-Looking Statement
This press release contains forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as "believes," "estimates," "projects," "expects," "may," "intends," "will," "should," or "anticipates," or the negative thereof or similar terminology. These statements appear in a number of places in this press release and include statements regarding IMC's or its management's intent, belief, or current expectations with respect to, among other things: IMC's regulatory approvals, future clinical trials, financial projections regarding IMC's future financial performance and condition, trends affecting IMC's financial condition and results of operations, and IMC's business and growth strategies. Forward-looking statements are subject to risks, uncertainties, and assumptions about IMC.
In light of these risks, uncertainties, and assumptions, IMC can give no assurance that the events disclosed in the forward-looking statements in this press release will in fact transpire. IMC undertakes no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events, or otherwise. IMC expressly disclaims any representation regarding any forward-looking statements. All forward-looking statements in this press release are expressly qualified by the foregoing cautionary statements.
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This 16 week, randomized double-blinded, placebo-controlled study was conducted at 12 research centers in the United States and enrolled 143 patients with fibromyalgia, as defined by the ACR 2010 criteria. The PRID-201 study demonstrated that patients randomized to IMC-1 (celecoxib+famciclovir) experienced a significant decrease in fibromyalgia-related pain vs patients randomized to placebo. Over 50% of the IMC-1 patients had at least a 30% reduction of pain and 38% of them achieved at least a 50% reduction in pain during the study. Patient global impression of change (PGIC) and the revised disease specific fibromyalgia impact questionnaire (FIQ-R) response rates were also significantly improved. Additionally, IMC-1 significantly improved self-reported fatigue, as measured by the NIH developed PROMIS fatigue inventory. Essentially all primary endpoints and most of the secondary endpoints met statistical significance in the PRID201 Trial.
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The safety profile was very encouraging. Despite the celecoxib component of IMC-1, common gastrointestinal (29.0% vs 42.5%) and nervous system (17.4% vs 23.3%) treatment emergent adverse events were reported less frequently in the IMC-1 group than in the placebo treated group. Overall, Study completion rates favored IMC-1 (82.6% vs 60.8%), showing a positive impact on adherence to therapy.
The results of this study suggest that IMC-1 is safe and efficacious in the treatment of the symptoms of fibromyalgia. Based on a novel mechanism of action and the study results showing efficacy on a range of important outcome measures, improved retention rates, decreased adverse event rates, IMC-1 may represent an effective and differentiated treatment for fibromyalgia sufferers.
After completion of the PRID-201 trial, the FDA granted IMC-1 fast track status, finding that FM is a serious disease with a large unmet need and that IMC-1 has the potential to meet that need. IMC plans to start a Phase 3 randomized, double-blinded, multi-center, factorial pivotal trial, using an improved IMC-1, later this year.
About Innovative Med Concepts
Innovative Med Concepts, LLC, is a biotech company developing novel treatments for fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), irritable bowel syndrome and other related conditions. On the Web: http://innovativemedconcepts.com.
Forward-Looking Statement
This press release contains forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as "believes," "estimates," "projects," "expects," "may," "intends," "will," "should," or "anticipates," or the negative thereof or similar terminology. These statements appear in a number of places in this press release and include statements regarding IMC's or its management's intent, belief, or current expectations with respect to, among other things: IMC's regulatory approvals, future clinical trials, financial projections regarding IMC's future financial performance and condition, trends affecting IMC's financial condition and results of operations, and IMC's business and growth strategies. Forward-looking statements are subject to risks, uncertainties, and assumptions about IMC.
In light of these risks, uncertainties, and assumptions, IMC can give no assurance that the events disclosed in the forward-looking statements in this press release will in fact transpire. IMC undertakes no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events, or otherwise. IMC expressly disclaims any representation regarding any forward-looking statements. All forward-looking statements in this press release are expressly qualified by the foregoing cautionary statements.
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