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Biosplice Announces Upcoming Presentation of Successful OA-07 Phase 3 Long-Term Structure and Pain & Function Results for Lorecivivint for Treatment of Knee Osteoarthritis at OARSI Conference, and Completion and Preliminary Analysis of OA-21 Trial…

Final analysis of OA-07 results demonstrated statistically significant improvement in joint structure, WOMAC Pain and WOMAC Function, highlighting potential of lorecivivint to be first-in-class, structure-modifying drug for treatment of knee osteoarthritis (OA). Preliminary analysis of OA-21 short-term pain results did not achieve statistical significance

SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, recently completed two Phase 3 trials, OA-07 long-term structure, pain and function study, and OA-21 short-term pain study. Preliminary results of OA-07 study, initially reported in November 2023, had demonstrated statistically significant and clinically meaningful improvement in joint structure demonstrated by X-ray results of medial joint space width (medial JSW). Final analysis of OA-07 results confirmed this structural benefit and further demonstrated that patients also experienced statistically significant reduction in their pain (as measured by WOMAC Pain at Month 6 and Month 12) and significant improvement in function (as measured by WOMAC Function at Month 12). Biosplice will present its OA-07 results at the Osteoarthritis Research Society International (“OARSI”) World Congress, April 18-21, 2024, in Vienna, Austria.  

“Patients are desperately seeking a new and safe approach for treating knee osteoarthritis that can provide durable pain relief, improved function, and joint structure benefit,” commented Biosplice Chief Medical Officer, Dr. Yusuf Yazici. “We are very encouraged by our unique data from our OA development program, and especially the recent OA-07 trial, and look forward to sharing these results with the medical community in upcoming meetings.”

With respect to the shorter-term OA-21 study, preliminary analysis showed that the study did not meet the primary endpoint of pain reduction at Week 12. The Company observed an unusually high placebo response in this trial compared to published intra-articular OA trials and Biosplice’s prior trials. The Company is currently analyzing these preliminary OA-21 results to further discern what may have caused this result in contrast with the successful OA-07 results, as well as the successful short- and long-term pain and function results of the OA-04 Phase 2 study.

The primary goal of Biosplice OA program has been to develop a first-in-class drug that could provide the more than 30 million OA patients in the US, and many more worldwide, with an effective treatment option that would go beyond mere short term pain relief. The cumulative data from Biosplice’s OA program to date, especially in light of the final results of the OA-07 Phase 3 X-ray study, provide strong support in service of this goal. OA-07 study results show that lorecivivint (1) provided a structural benefit in a statistically significant and clinically meaningful manner in moderate and advanced OA patients, a first-in-class attribute among OA treatment options, (2) reduced patients’ pain, (3) improved their function with (4) a remarkably clean safety profile to date.

With the benefit of these clinical results, Biosplice intends to consult with the US Food and Drug Administration (FDA), as well as regulatory agencies in other countries, for further guidance on the path to marketing approval of lorecivivint.

About Biosplice
Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis and cirtuvivint for numerous cancers, with a broad pre-clinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions.

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Corporate Contact:
Erich Horsley 

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