SAN DIEGO, April 4, 2016 /PRNewswire/ -- At the 2016 World Congress on Osteoarthritis, held March 31-April 3, 2016 in Amsterdam, Netherlands, Samumed presented clinical (See #1 below) and preclinical (See #2 below) results from its osteoarthritis program using SM04690—a novel small molecule inhibitor of the Wnt pathway administered via intra-articular injection. The background, methodologies, and results presented for the preclinical and clinical studies are detailed in the respective presentations.
- "OMERACT-OARSI 'Strict Responders' Analysis from Results of a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of a Novel, Intra-Articular, Injectable Wnt Inhibitor (SM04690) in the Treatment of Osteoarthritis of the Knee." (Click here), and
- "Discovery of a Small Molecule Inhibitor of the Wnt Pathway (SM04690) as a Potential Disease Modifying Treatment of Osteoarthritis." (Click here)
In a Phase 1 clinical trial, a pre-specified analysis of exploratory efficacy results suggested that, 12 weeks after treatment, subjects treated with SM04690 (0.07mg) were more likely to achieve an OMERACT-OARSI strict therapeutic response than placebo. Outcome Measures in Rheumatology Clinical Trials (OMERACT)- Osteoarthritis Research Society International (OARSI) Strict Responder criterion is a composite of multiple osteoarthritis pain or function evaluations of the subject resulting in a binary assessment of whether a clinically-relevant improvement is achieved as a result of the treatment.
OMERACT-OARSI Strict Responder at Week 12 [mITT]
12 weeks after the injection, 76% of the patients who received 0.07 mg of SM04690 (N=17) achieved strict OMERACT-OARSI response compared to 36% of the patients who received placebo (N=11) (Odds Ratio = 5.7, P = 0.04) (mITT refers to modified Intent-to-Treat, as defined in presentation #1).
Structural improvements were observed in preclinical models of osteoarthritis of the knee, such as an increase in cartilage thickness, a decrease in fissures, and remodeling of subchondral bone, after a single intra-articular injection of SM04690. (Click here and see slide 11 for details)
A Phase 2 clinical study of SM04690 with 445 patients (NCT02536833) is currently ongoing, investigating additional safety, dose response, efficacy, and potential disease modification in patients with osteoarthritis of the knee.
About SAMUMED, LLC
Based in San Diego, CA, Samumed (www.samumed.com) is a pharmaceutical platform company focused on advancing regenerative medicine and oncology applications through research and innovation. Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the team to develop small molecule drugs that potentially address numerous degenerative conditions as well as many forms of cancer.
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