Biosplice Publishes Phase 2B Lorecivivint Analysis Showing Clinically Meaningful Benefits to Knee Osteoarthritis Patients
SAN DIEGO, July 22, 2021 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering therapeutics based on alternative pre-mRNA splicing for major diseases, announced today the publication of a post-hoc analysis of its successful Phase 2b knee osteoarthritis clinical trial in Rheumatology and Therapy. Biosplice showed that study subjects dosed with 0.07 mg lorecivivint were over two times more likely to meet the criteria for OMERACT-OARSI Strict Response, a measure that includes 50% improvement in pain or function, than those on placebo at 12 weeks. Further, this response was maintained until the end of the study at 24 weeks.
- The importance of this analysis is that we are able to highlight the magnitude of the superiority of lorecivivint treatment for knee OA pain and function over placebo, said Biosplice Chief Medical Officer, Yusuf Yazici, MD.
- While our successful Phase 2b study already demonstrated that lorecivivint significantly outperformed placebo in daily pain measurements out to six months, this further analysis sheds new light on the high potential of lorecivivint to relieve osteoarthritic patient suffering.
- These confirmatory Phase 3 clinical trials ( NCT04385303 and NCT03928184 ) are further evaluating the impact of lorecivivint on knee osteoarthritis pain, function, and structure and have been modeled after Biosplices successful Phase 2b trial.
- As reported earlier in the primary analysis of the Phase 2b study results, safety findings were similar between lorecivivint and placebo.