MediciNova

MediciNova presented interim analysis results from its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS at the 35th International Symposium on ALS/MND. The study has enrolled 217 participants, with 183 assigned to treatment or placebo groups as of November 15, 2024. The interim analysis revealed positive correlations between 6-month and 12-month data for various metrics: CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). The Data Safety Monitoring Board recommended continuing the trial as planned. Patient assignments are expected to complete by June 2025, with trial results anticipated in 2026.

MediciNova announces COMBAT-ALS Phase 2b/3 trial update and interim analysis results of MN-166 (ibudilast) in ALS, showing positive correlations between 6-month and 12-month data, and recommends trial continuation. Over 200 patients enrolled, with trial completion expected in 2026.

DelveInsight's 'Clostridium Difficile Infections Pipeline Insight, 2024' report details 20+ companies developing 22+ therapies, including Vedanta Biosciences' VE303 in Phase 3 and Ferring Pharmaceuticals' REBYOTA® approved by FDA in 2022. The report covers clinical trials, mechanisms of action, and route of administration for emerging treatments.

Widetrial supports an expanded access program (EAP) funded by a $22 million federal grant to Mayo Clinic, providing MN-166 (ibudilast) to ALS patients not eligible for clinical trials. The program aims to enroll 200 patients across Mayo Clinic sites and other U.S. institutions, focusing on measuring treatment effects on disease progression and neurofilament light chain (NfL) levels over six months. Patients can monitor their own NfL levels and contribute to an ALS biobank. MediciNova is also sponsoring a Phase 2b/3 trial, COMBAT-ALS, testing MN-166 against a placebo.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

Biopharma updates: deals, partnerships, grants, preclinical data, and other news involving 23andme, Centessa, Egenesis, Enveric, Formation, Kancera, Medicinova, Mycomedica, Organox, Sanofi.

MediciNova announced Dr. Björn Oskarsson's update on the Phase 2/3 trial of MN-166 (ibudilast) in ALS patients at the 2024 NEALS Meeting. The trial, funded by NIH, includes new clinical trial protocols for ALS patients.

MediciNova announced Dr. Björn Oskarsson's presentation on the Phase 2/3 trial of MN-166 (ibudilast) in ALS at the 2024 NEALS Meeting, discussing study design, objectives, and enrollment updates, along with new NIH funding for an ALS clinical trial.

MediciNova receives $22 million from NIH-NINDS for an Expanded Access Protocol to evaluate MN-166 (ibudilast) in ALS, supported by the ACT for ALS Act.