FAIRFAX, Va.--(BUSINESS WIRE)--Vizuri Health Sciences LLC, a pharmaceutical development company, today announced that it has been selected to make an oral presentation of findings from a randomized, double blind Phase 2 osteoarthritis (OA) knee pain study (VZU00025, NCT03528369) at the American College of Rheumatology and the Association of Rheumatology Health Professionals’ 2019 Annual Meeting, which will take place from November 8-13 in Atlanta, Georgia. Details of the presentation are shown below.
Abstract Title (#2760): A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)
Session: Osteoarthritis – Clinical II: Novel Therapies
Date, Time, and Location: Tuesday, November 12, 2019, from 3:30 PM - 3:45 PM in Room B206
Full meeting abstracts can be viewed on-line at ACR abstracts.org.
Abstract #2760 reports that CGS-200-5 was well-tolerated and was efficacious. Efficacy and safety highlights will be presented at the ACR meeting, including:
- As shown in the table below, CGS-200-5 met the primary Day 35 WOMAC pain efficacy endpoint compared to vehicle (p = 0.020) and post-hoc analysis showed statistical separation from vehicle on Days 64 (p = 0.0001) and 94 (p = 0.0111) following application to the knees on Days 1-4.
- Post-hoc analysis showed a statistical decrease in WOMAC OA total score (a composite index of knee pain, stiffness, and function) for CGS-200-5 compared to vehicle at Days 35, 64 and 94.
- The proportion of CGS-200-5 subjects with a Day 94 durable clinical response (WOMAC pain reductions > 50% on at least 4 of 5 study day visits) was 29.3% (p = 0.1004 compared to vehicle).
Summary of WOMAC OA Pain Score Change from Baseline through Day 94 - mITT Set |
||||||||
Day |
|
LSM Difference |
|
Between Group Difference |
|
95% CIa |
|
p-valuea |
35 |
|
CGS-200-5 – CGS-200-0 |
|
-61.0 |
|
(-112.3, -9.8) |
|
0.0200 |
64 |
|
|
|
-94.7 |
|
(-142.4, -47.1) |
|
0.0001 |
94 |
|
|
|
-67.0 |
|
(-120.0, -15.8) |
|
0.0111 |
Abbreviations: LSM, Least-squares means; mITT, modified intent-to-treat |
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aANCOVA model for comparison of change from baseline with treatment as a fixed effect and baseline value as a covariate |
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Marc C. Hochberg, MD, MPH, MACP, MACR, Professor of Medicine and Head of Rheumatology and Clinical Immunology at the University of Maryland School of Medicine, observed, “Given the emphasis on the use of topical agents as first choice for the local treatment of pain associated with knee osteoarthritis, as noted in both the 2019 American College of Rheumatology and 2019 Osteoarthritis Research Society International recommendations, these data suggest that CGS-200-5 will be a useful first-line treatment for patients with knee osteoarthritis.”
About OA
According to the Centers for Disease Control and Prevention, OA is the most common joint disease in the United States, currently affecting more than 30 million Americans. OA most often affects joints in the knees, hands, hips, and lower back and neck. OA is due to cartilage deterioration within the joint and causes pain, swelling and declines in flexibility and overall function. Over time, patients with knee OA tend to become inactive due to pain, joint stiffness and reduced function. Inactivity due to OA is associated with health risk conditions such as cardiovascular disease, diabetes, and obesity.
About CGS-200-5
CGS-200-5 is a patented, next-generation, high potency topical treatment for the relief of OA and is wholly owned by Vizuri. It is being developed to address the high unmet medical need for an OA pain treatment that is highly and durably effective, can be self-administered, does not require everyday use and that is safe (e.g., without the gastrointestinal, liver or addiction risk associated with other common treatments).
About Vizuri Health Sciences LLC (www.vizuriusa.com)
Privately-owned Vizuri develops new innovative healthcare products that utilize proprietary formulations to enhance the efficacy or safety of pharmaceutical ingredients that have proven health benefits.
