Biosplice Publishes Phase 2B Lorecivivint Analysis Showing Clinically Meaningful Benefits to ...
Lorecivivint post-hoc analysis reveals significantly increased likelihood of symptom improvements for knee osteoarthritis compared to placebo
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.”
The full post-hoc analysis publication can be viewed at: https://link.springer.com/article/10.1007/s40744-021-00316-w.
Biosplice is currently conducting two Phase 3 trials for lorecivivint, STRIDES-1 and STRIDES-X-ray. 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 Biosplice’s 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.
Biosplice is developing first-in-class, small-molecule therapeutics based on pioneering science of alternative pre-mRNA splicing. Stemming from foundational discoveries in Wnt pathway modulation, Biosplice has elucidated novel biology linking CLK/DYRK kinases to the therapeutic regulation of alternative splicing. Alternative splicing is an essential biological mechanism that regulates the diversification of proteins in a cell, which, in turn, determines cell type and function. Biosplice’s target class governs the selection of tissue-specific mRNA splice sites, making them attractive, druggable targets within the cellular “command and control” center.
Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis (in Phase 3), cirtuvivint for numerous cancers, and a broad pipeline that ranges from Alzheimer’s disease to other degenerative conditions. Learn more at https://www.biosplice.com.
Biosplice Therapeutics, Inc.