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MediciNova Announces Health Canada Grants Authorization to Commence Multi-arm Phase 2/3 Clinical Trial to Evaluate MN-166 (ibudilast) in Long COVID
LA JOLLA, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the
About this update from Medicinova, Inc.
[{"type":"text","content":"LA JOLLA, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that Health Canada has completed its review of the clinical trial application and has granted authorization to commence a grant-funded, multi-center, randomized, clinical trial to evaluate MN-166 (ibudilast) and other therapies for the treatment of Long COVID, the lingering symptoms of COVID-19. The trial, entitled REcovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine, or “RECLAIM,” is a collaboration between MediciNova and the University Health Network, the largest hospital-based research program in Canada. MediciNova will supply the study drug and will provide regulatory and safety follow-up support. Kazuko Matsuda, M.D. Ph. D, M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “Since COVID-19 became a global health threat, multiple vaccines and treatment options became available, yet not many treatment options have been evaluated in COVID-19 sequelae, so-called Long COVID. There is a large unmet medical need for patients with this disorder, which can have serious ramifications on quality of life, health care utilization and ability to return to work. We are very excited about the initiation of this multi-arm Phase 2/3 trial to evaluate MN-166 as a drug candidate for Long COVID.” About the RECLAIM Trial This is a Canada-wide Phase 2/3, prospective, adaptive, randomized, placebo-controlled platform trial to evaluate various interventions for patients with lingering symptoms of COVID-19 (“Long COVID”). Participants will be randomly assigned to 1 of 4 arms, MN-166 (ibudilast), pentoxifylline, or their respective matching placebo, including standard of care for 2 months, and will be followed for an additional 4 months. Approximately 800-1000 patients with Long COVID will be recruited at Canadian sites. The primary outcome measure is the mean change in the SF-36 (v.1) physical component score (PCS) from baseline to 2 months. As this is an adaptive design study, Intervention arms may be discontinued based on interim analysis results, and new interventions may be selected and included as part of the platform as the trial progresses. About Long COVID While most patients with C...