Drug development for neurodegenerative diseases
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MediciNova Announces 100 Patients Enrolled in SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN‑166 (ibudilast) in ALS patients
Globenewswire· 2026-01-29 23:00
Core Insights - MediciNova, Inc. has achieved significant progress in its SEANOBI study for MN-166 (ibudilast), with 100 patients enrolled, representing 50% of the target enrollment of 200 patients [1][2] - The SEANOBI Expanded-Access Program is funded by a $22 million grant from NINDS under the ACT for ALS initiative, aimed at providing treatment access to ALS patients not eligible for clinical trials while collecting valuable clinical data [2][4] - MN-166 is also being evaluated in the COMBAT-ALS Phase 2b/3 trial, with top-line results expected by the end of 2026 [3][5] SEANOBI Study - The SEANOBI study is designed to evaluate MN-166 in ALS patients and aims to enroll approximately 200 patients across 12 active sites [4] - The program focuses on generating real-world clinical outcomes and biomarker data, including neurofilament levels, to support future regulatory discussions [2][4] COMBAT-ALS Trial - The COMBAT-ALS trial is a randomized, placebo-controlled study assessing the efficacy and safety of MN-166, with 234 patients enrolled in the U.S. and Canada [3][5] - The trial includes a 12-month double-blind period followed by a 6-month open-label extension, with results anticipated by the end of 2026 [3][5] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a late-stage pipeline including MN-166 and MN-001 [8] - MN-166 has received Orphan Drug Designation from the FDA and EMA, as well as Fast Track Designation from the FDA for ALS treatment [7][8]
Alterity Therapeutics to Present at the Biotech Showcase
Globenewswire· 2025-09-02 11:25
Core Insights - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly Parkinson's disease and related disorders [2][4] - The company will present a corporate update at the Biotech Showcase on September 3, 2025, in Australia and September 2, 2025, in the United States [1][2] Company Overview - Alterity Therapeutics is a clinical-stage biotechnology firm based in Melbourne, Australia, and San Francisco, California, dedicated to creating therapies for neurodegenerative diseases [2] - The company has shown clinically meaningful efficacy for its lead asset, ATH434, in a Phase 2 clinical trial for Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder [2] - ATH434 has recently reported positive data in an open-label Phase 2 clinical trial for advanced MSA [2] - Alterity has a broad drug discovery platform that generates patentable chemical compounds aimed at treating the underlying pathology of neurological diseases [2]