Biosplice’s osteoarthritis drug has failed a Phase 3 clinical trial, according to the drugmaker, significantly clouding the drug’s chances of approval and the future of a company that was once valued at $12 billion.
Presentation of OA-07 Phase 3 Long-Term Results for Lorecivivint and Preliminary Analysis of OA-21 Trial 12-Week Pain Results
Biosplice Therapeutics Announces Department of Defense (DoD) Award
Biosplice Therapeutics, Inc. (Biosplice), a clinical-stage biotechnology company, announced potential structure-modifying highlights from an ongoing long-term extension study, OA-07, for its knee OA drug candidate, lorecivivint (LOR).
Biosplice Announces Interim Data from Phase 3 Long-Term Extension Clinical Trial in Knee Osteoarthritis and the Initiation of a New Phase 3 Trial
SAN DIEGO, Nov. 11, 2022 (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, announced today highlights from three Phase 3 clinical trials, OA-07, OA-10 and OA-11 for its knee OA drug candidate, lorecivivint. Recent Biosplice data, particularly in the OA-07 long-term efficacy trial, demonstrate both symptomatic and structural benefit in treating knee osteoarthritis in patients with early joint damage, defined as KL2 and early-stage KL3 patients, which represent an estimated 70% of the knee OA population.
SAN DIEGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering therapeutics based on CLK/DYRK kinase modulation for major diseases, announced today the presentation of new clinical data for cirtuvivint (SM08502), its first-in-class small-molecule CLK/DYRK inhibitor. The oral presentation was delivered in Paris, France at the 2022 European Society for Clinical Oncology (ESMO) meeting. With evidence of clinical benefit, cirtuvivint is currently progressing through two Phase 1 trials as a drug candidate for the treatment of advanced solid tumors. In addition, Biosplice is developing next-generation, highly-selective drug candidates within its CLK/DYRK target class for a broader array of cancers, including liquid tumors.
After reaching a $12 billion valuation in 2018, Biosplice appears to be falling back down to Earth, and its workforce is taking the brunt. The company is laying off 41 workers, according to a Tuesday announcement. The San Diego biotech also culled a male pattern baldness drug from its pipeline.
SAN DIEGO, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, nInc. (“Biosplice”), a clinical-stage biotechnology company pioneering ntherapeutics based on CLK/DYRK kinase modulation for major diseases, nannounced the dosing of the first subject in a Phase 1b, open-label, nmulti-center, dose-escalation, dose expansion clinical trial of ncirtuvivint in subjects with advanced solid tumors. Several nstandard-of-care agents are being tested in combination with cirtuvivintnin diseases including castration resistant prostate cancer (CRPC), nnon-small cell lung cancer (NSCLC), and colorectal cancer (CRC). Many npatients with these types of cancers progress on earlier line ntreatments, and these patients critically need new combination agents nthat improve response rates or extend the duration of response for nlate-stage cancer patients.
Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering therapeutics based on CLK/DYRK kinase modulation for major diseases, and Haisco Pharmaceutical Group Co., Ltd. (“Haisco”), a pharmaceutical company based in the People’s Republic of China (“China”), announced the execution of a licensing agreement that grants Haisco the right to develop and exclusively commercialize lorecivivint (SM04690) for the treatment of knee osteoarthritis (“OA”) and other musculoskeletal conditions in China.