Samumed Announces 52-week Phase 2 Osteoarthritis Data Supporting the Potential of SM04690 as a Disease Modifying Drug

San Diego, UNITED STATES


- SM04690 exhibited clinically meaningful and significant improvements in pain, function, and joint space width in unilateral symptomatic osteoarthritis patients -

- Samumed will be presenting data in three presentations at the 2017 ACR/ARHP Annual Meeting -

SAN DIEGO, Oct. 24, 2017 (GLOBE NEWSWIRE) -- Samumed, LLC, today announces highlights from its 52-week Phase 2 proof-of-concept study of SM04690 in osteoarthritis (OA) of the knee, lending support to SM04690’s potential as a disease modifying osteoarthritis drug (DMOAD). In unilateral symptomatic knee OA patients, one of the three doses (0.07mg) of a single intra-articular injection of SM04690 showed clinically meaningful and significant improvements compared to placebo in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores. In the same prespecified patient population, SM04690 potentially maintained or increased medial joint space width (mJSW) compared to placebo, where changes in mJSW were predictive of WOMAC pain and function improvement. 

Similar trends were observed in the intent to treat (ITT) group, as well as in the other two doses studied. Detailed results from the 52-week study will be presented at the 2017 ACR/ARHP Annual Meeting being held on Nov. 3-8 in San Diego:

Oral presentation
 
 Presentation Title:  Results from a 52 Week Randomized, Double-Blind, Placebo-
Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt
Pathway Inhibitor (SM04690) for the Treatment of Knee
Osteoarthritis
 Presenter: Yusuf Yazici, M.D.
 Session Title: Osteoarthritis – Clinical Aspects I:  Structural Progression & Incidence
 Date/Time: Sunday, Nov. 5, at 5:30 p.m. PST 
 Abstract Number: 935
    
Poster presentations
 
 Presentation Title: Reducing Heterogeneity in OA Clinical Trials: Data from a Phase
2 Study of SM04690, a Novel, Intra-Articular, Wnt Pathway
Inhibitor in Knee Osteoarthritis
 Session Title: Osteoarthritis – Clinical Aspects Poster I: Clinical Trials and Interventions
 Date/Time:  Monday, Nov. 6, from 9-11 a.m. PST
 Abstract Number: 1201
    
 Presentation Title: Radiographic Outcomes Were Associated with Pain and Function
Responses: Post-Hoc Analysis of Results from a Phase 2 Study of
a Small Molecule Wnt Pathway Inhibitor, SM04690, for Knee
Osteoarthritis Treatment
 Session Title:  Osteoarthritis – Clinical Aspects Poster I: Clinical Trials and Interventions
 Date/Time:  Monday, Nov. 6, from 9-11 a.m. PST
 Abstract Number: 1204
    

About SM04690 
SM04690 is a small molecule inhibitor of the Wnt pathway administered as an intra-articular injection, and is being developed as a potential disease modifying drug for osteoarthritis (DMOAD). Preclinical data suggest SM04690 has a dual mechanism of action with three specific effects on joint health – generating new articular cartilage, slowing down cartilage degradation, and reducing inflammation in the joint. Additional information on Samumed’s SM04690 Osteoarthritis program can be found here: 
https://www.samumed.com/pipeline/detail.aspx?id=20

About Samumed 
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Samumed’s clinical pipeline can be found here: https://www.samumed.com/pipeline/default.aspx

Corporate Contact:
Erich Horsley
Samumed, LLC
erich@samumed.com
858-365-0200

Investor Contact:
Ashley Robinson
LifeSci Advisors
arr@lifesciadvisors.com
617-535-7742

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
646-627-8384