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Samumed Presents Clinical and Preclinical Data at European League Against Rheumatism (EULAR) 2018 Annual Congress

Phase 2 data in osteoarthritis and preclinical data in tendinopathy and psoriasis demonstrated the emerging breadth of the Samumed pipeline in arthritis related diseases and in dermatology

SAN DIEGO, June 20, 2018 (GLOBE NEWSWIRE) -- Samumed, LLC presented one oral presentation and five posters highlighting recent clinical and preclinical data for two of the company’s investigational drugs, SM04690 for the treatment of knee osteoarthritis (OA), and SM04755 for the treatments of psoriasis and tendinopathy, at the European League Against Rheumatism (EULAR) 2018 Annual European Congress of Rheumatology, held in Amsterdam from June 13-16, 2018. Additionally, two analyses of randomized-controlled trials (RCTs) in knee OA examining the effects of intra-articular (IA) saline injections on patient responses were shown in separate posters.

“The data we presented at the EULAR conference highlighted the variety of Samumed pipeline compounds being developed for arthritic diseases,” said Yusuf Yazici, M.D., Chief Medical Officer of Samumed.

Key clinical data presented in one oral presentation entitled, “Treatment of Knee Osteoarthritis with SM04690 Improved WOMAC A1 “Pain on Walking” – Results From a 52 Week, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel Intra-Articular, Wnt Pathway Inhibitor,” included:

  • In a Phase 2 study of 455 subjects with knee OA, those from a subgroup with predominantly single knee pain, treated with 0.07 mg SM04690 showed statistically significant improvements in a post-hoc analysis of the response to the question WOMAC A1 “How much pain have you had when walking on a flat surface?’ compared to placebo (PBO) at Weeks 39 (P=0.043) and 52 (P=0.027).
  • In those from a subgroup with predominantly single knee pain and without pain from other conditions, subjects treated with 0.07 mg SM04690 demonstrated statistically significant improvements in WOMAC A1 compared to PBO at Week 26 (P=0.015), Week 39 (P=0.004), and Week 52 (P=0.010).

Preclinical and clinical data on SM04690 as a potential knee OA treatment were presented in three posters entitled, “Results from a 52-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Wnt Pathway Inhibitor (SM04690) for Knee Osteoarthritis Treatment,” “Radiographic outcomes were associated with pain and function responses: Post-hoc analysis from a phase 2 study of a Wnt pathway inhibitor, SM04690, for knee osteoarthritis treatment,” and  “SM04690, a Wnt Pathway Inhibitor: Anti-Inflammatory and Cartilage Protective Effects in Preclinical OA Models.” Key points included:

  • Clinical and radiographic outcomes suggested that SM04690 is a potential disease modifying osteoarthritis drug (DMOAD), especially in a post-hoc defined subgroup of subjects with predominantly single knee pain and without pain from other conditions treated with the 0.07 mg dose.
  • In a post-hoc study, subjects from a subgroup with predominantly single knee pain, and without pain from other conditions treated with 0.07 mg SM04690 were analyzed. Increases in X-ray measured joint space width were associated with an improved pain and function response.
  • In a rat model of knee OA, SM04690 injection reduced inflammation, improved pain, and protected cartilage, compared with vehicle.

Key preclinical data on SM04755 for the treatments of tendinopathy and psoriasis presented in two posters entitled, “Small molecule inhibitor of the Wnt pathway (SM04755) as a potential topical treatment for psoriasis” and “Experimental tendinopathy treatment with SM04755, a topical small molecule inhibitor of the Wnt pathway” included:

  • In a mouse model of psoriasis, SM04755 applied to the skin reduced inflammation, decreased skin and ear thicknesses, and improved skin appearance and mouse weight compared with untreated mice.
  • In an acute dose-response rat model of tendinopathy and a repeat injury/delayed treatment rat model of tendinopathy, SM04755 demonstrated accelerated improvement of microscopic tendon appearance compared with untreated mice.

Data from two analyses of RCTs were presented in two posters entitled, “Potential Nociceptive Pain Relief of Intra-Articular Saline Control in Clinical Trials of Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Trials” and “Adjusting for the Intra-Articular Placebo Effect in Knee Osteoarthritis Therapies.” The data presented included the following point:

  • The findings from both analyses highlight that using IA saline as a PBO in RCTs testing drugs for knee OA pain can potentially lead to an underestimation of the true effects of these drugs.

A copy of the presentation materials can be found in the Publications section of the Samumed website.

About the European League Against Rheumatism (EULAR)

The European League Against Rheumatism (EULAR) is the organization which represents the patient, health professional and scientific societies of rheumatology of all the European nations. EULAR endeavors to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic diseases. In line with UEMS, EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems.

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 suggested SM04690 has a dual mechanism of action with three specific effects on joint health – generation of 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 SM04755

SM04755 is a small-molecule Wnt pathway inhibitor and is being developed as a potential topical therapeutic for tendinopathy. Preclinical data suggested that SM04755 may inhibit inflammation, reduce fibrosis, and increase tenocyte differentiation (tendon repair). Additional information on Samumed’s SM04755 tendinopathy program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=13

SM04755 is also being developed as a potential topical treatment for psoriasis. Preclinical data suggested SM04755 has the potential to attenuate inflammation, epidermal thickening, and fibrosis. Additional information on Samumed’s SM04755 psoriasis program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=11

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. Learn more about Samumed’s potential regenerative drug candidates and broad clinical pipeline at 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

Wednesday, June 20, 2018 - 08:00