Medicinova Stock Price, News & Analysis

MediciNova (NASDAQ:MNOV) has announced the enrollment of the first patient in an NIH-funded Expanded Access Program (EAP) trial evaluating MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients. The trial aims to provide access to MN-166 for ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial.

The EAP trial, funded by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), will assess the safety and efficacy of MN-166 in approximately 200 ALS patients. This initiative specifically targets individuals in advanced stages of ALS who cannot participate in the current Phase 2/3 COMBAT-ALS trial.

MediciNova (NASDAQ:MNOV) 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). Strong correlations were also observed in Bulbar (0.74), Fine motor (0.71), and Gross motor scores (0.67). 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. The company is also supporting continued treatment through FDA's Expanded Access Program.

MediciNova's CEO Yuichi Iwaki provided a corporate update highlighting the company's strategy of partnering with institutions and government agencies to conduct clinical trials while preserving capital. The company announced a collaboration for an NIH-funded Phase 2-3 ALS Expanded Access study of MN166 (ibudilast), running parallel to their COMBAT-ALS trial. The company maintains $42.3 million in cash as of September 30, 2024, and expects additional non-dilutive funding from a Sanofi/Novartis settlement. Other ongoing partnerships include a Health Canada-funded Long COVID trial and various programs with U.S. government agencies, where MediciNova primarily provides study drug and administrative support.

MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the USPTO for a new patent covering MN-001 (Tipelukast) for decreasing triglyceride synthesis in the liver. The patent application covers a method of administering MN-001 or its metabolite to subjects with insulin resistance, pre-diabetes, or diabetes. The patent, expected to expire no earlier than May 26, 2042, includes claims for various formulations and administration methods. The compound can be administered orally with flexible dosing frequencies.

MediciNova (NASDAQ: MNOV) announced it will receive monetary damages following the settlement of Sanofi-Novartis litigation. The company plans to use this non-dilutive funding to support ongoing clinical development programs, particularly focusing on their late-stage pipeline targeting inflammatory, metabolic, and neurodegenerative diseases. The settlement validates MediciNova's intellectual property value and strengthens their financial position as they advance their novel small molecule therapies towards commercialization.

MediciNova (NASDAQ:MNOV) provided an update on its ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients at the 2024 Annual NEALS Meeting. Lead Principal Investigator Dr. Björn Oskarsson presented details about the COMBAT-ALS trial, including the study design, objectives, and major inclusion criteria. The presentation also covered enrollment updates as of October 18, 2024, and discussed a new NIH-funded Expanded Access Protocol clinical trial in ALS patients.

MediciNova (NASDAQ:MNOV) has announced its support for an NIH-funded Expanded Access Protocol (EAP) trial to evaluate MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS). The NIH-NINDS has awarded $22 million for this intermediate-size trial, which will allow 200 ALS patients who are ineligible for the ongoing COMBAT-ALS trial to receive treatment with MN-166.

MediciNova will provide the investigational drug, regulatory support, and safety monitoring. The trial will evaluate neurofilament light, a biomarker for neuron damage, and clinical data. This initiative is supported by the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), signed into law by President Biden.

MediciNova, Inc. (NASDAQ:MNOV) has announced that an abstract regarding the COMBAT-ALS clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) treatment has been accepted for poster presentation at the 35th International Symposium on ALS / MND. The symposium will take place from December 6-8, 2024, in Montreal, Canada.

The presentation, titled 'COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results', will be delivered by lead Principal Investigator Dr. Björn Oskarsson, Associate Professor of Neurology and Director of ALS Center of Excellence at Jacksonville, FL. The abstract has been assigned Paper Number 302 and falls under the theme of Clinical Trial and Trial Design.

MediciNova (NASDAQ:MNOV) announced the acceptance of an abstract for presentation at the 2024 Annual NEALS Meeting regarding their COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS). The poster presentation, titled 'COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update,' will be delivered by lead Principal Investigator Dr. Björn Oskarsson on October 23rd, 2024. The NEALS Meeting, a hybrid event, will take place from October 21-24, 2024, in Clearwater, Florida, and online. This presentation represents an important milestone in MediciNova's ALS research and development efforts.