Samumed Initiates Phase 1b Trial of SM04755 for Treatment of Psoriasis


- Top-line data expected by Q2 2018 -

SAN DIEGO, Oct. 31, 2017 (GLOBE NEWSWIRE) -- Samumed, LLC, today announces the enrollment of the first psoriasis patient in its Phase 1b trial of SM04755, a small molecule Wnt pathway inhibitor formulated as a topical lotion. 

This Phase 1b single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending doses of SM04755 in subjects with mild-to-moderate plaque psoriasis. Subjects will receive 28 days of daily drug administration and will be followed up for 28 days after last treatment. Primary objectives of the Phase 1b study include safety and tolerability, incidence of dose limiting toxicities and certain PK measures. As exploratory objectives, patient assessment of response in plaque severity, and itching will be assessed in addition to investigator assessment of improvement of lesions before and after treatment.  In previous in vitro studies, SM04755 inhibited inflammation, keratinocyte proliferation and fibrosis compared to controls. In addition, in an in-vivo mouse model, topically applied SM04755 inhibited inflammation, cell proliferation and decreased skin thickness compared to placebo. SM04755 also previously successfully completed a multiple ascending dose Phase 1 study in healthy subjects.

“The initiation of this Phase 1b study represents an important achievement for our SM04755 clinical development program,” said Dr. Yusuf Yazici, Chief Medical Officer of Samumed. “Based on the preclinical data generated to date, we believe SM04755 has significant potential in psoriasis. We look forward to the availability of top-line data from this Phase 1b study by Q2 2018.”

About SM04755
SM04755 is a small molecule, Wnt pathway inhibitor being developed for the treatment of psoriasis. SM04755’s mechanism-of-action has the potential of attenuating acute inflammation in multiple indications. In addition to psoriasis, SM04755 is being evaluated for chronic tendinopathy, a degenerative and fibrotic condition caused by injuries or overuse that has no FDA-approved treatments available.

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:

Corporate Contact:
Erich Horsley
Samumed, LLC

Investor Contact:
Ashley Robinson
LifeSci Advisors

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations