Phase I study for topical chronic tendinopathy therapy successfully completed, no adverse effects
Samumed’s topical gel was found to lead to no serious adverse events and aims to treat chronic tendinopathy, a degenerative condition that had no FDA-approved drug treatment options.
In results presented at European League Against Rheumatism 2017 Annual Meeting (Madrid, Spain, 14-17 June 2017), the Phase I clinical trial of Samumed’s (CA, USA) small molecule SM04755 found it to be associated with no adverse effects with the maximum tolerated dose not reached in any of the three treatment groups. Samumed hopes that SM04755 will eventually be able to treat chronic tendinopathy, a condition involving pain, swelling and impaired performance of the tendon. Tendinopathy can cause both inflammation and degeneration of the tendon and is estimated to affect 1-3% of the population.
In the study, SM04755, novel small molecule inhibitor of the Wnt pathway, was administered in a topical gel to daily for 14 days to 23 healthy subjects aged between 18 and 50. The subjects were split into three treatment groups, treated with ascending doses of SM04755, each with a placebo control. In previous studies, SM04755 has been shown to reduce inflammation, increase tendon regeneration markers and improve microscopic and macroscopic tendon structure. In rats, SM04755 has also been found to improve in vivo tendon healing in single and repeat collagenase-induced models of tendinopathy.
Further preclinical data was presented in a poster at the same meeting. The poster can be viewed here.
In a press release, Samumed commented: “The study results supported the continuation of the program into future studies in tendinopathy patients…[and] a detailed analysis, including safety and pK results, will be presented at a future medical conference”.