Medicinova Stock Price, News & Analysis

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.

MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering MN-166 (ibudilast) for post-COVID conditions. The Method of Use patent covers administering ibudilast to alleviate various post-COVID symptoms, including anxiety, fatigue, depression, and shortness of breath. The patent allows for multiple administration methods and dosing regimens, either alone or in combination with other active agents.

The patent is expected to expire no earlier than November 2042, providing extended exclusivity for MediciNova. The company is currently conducting a Phase 2/3 clinical trial in Long COVID in collaboration with University Health Network in Canada. MediciNova plans to initiate discussions with Health Canada for a New Drug Application if the RECLAIM study shows positive results.

MediciNova, a biopharmaceutical company listed on NASDAQ (MNOV) and Tokyo Stock Exchange, announces that David H. Crean, Ph.D., its Chief Business Officer, will now oversee investor engagement and public relations. Dr. Crean aims to enhance communication channels, providing stakeholders with clearer insights into the company’s vision and strategy. MediciNova plans to increase transparency through regular updates on milestones and achievements, hoping to attract new investors. CEO Yuichi Iwaki highlighted the company's active programs in neurodegeneration and other independently run projects that are expected to generate additional cash flow upon regulatory approvals. The company acknowledges a previous disconnect in market communication and is committed to improving clarity under Dr. Crean's leadership.

MediciNova has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering MN-166 (ibudilast) for preventing metastasis in cancers like pancreatic, lung, breast, colorectal, melanoma, and ovarian cancers.

The patent, expected to expire by July 2042, includes claims for using MN-166 in combination with therapies such as chemotherapy and immunotherapy.

It covers various administration methods, doses, and treatment durations, enhancing the intellectual property and value of MN-166.

Dr. Kazuko Matsuda, Chief Medical Officer, emphasized the significance of this patent in addressing metastasis, a major cause of cancer-related deaths.

MediciNova announced data from their Phase 1b/2a clinical trial of MN-166 (ibudilast) combined with Temozolomide (TMZ) in glioblastoma patients at the ASCO Annual Meeting 2024. The study included 62 patients, split between newly diagnosed (36) and recurrent (26) GBM cases. Primary endpoints were safety, tolerability, and efficacy. The combination treatment was safe and well-tolerated, with no unexpected adverse effects. Progression-Free Survival at 6 months (PFS6) was 44% for new and 31% for recurrent GBM, higher than historical controls in recurrent cases. Median PFS was 8.7 months for new and 2.4 months for recurrent GBM. Median Overall Survival was 21 months for new and 8.6 months for recurrent GBM. Preclinical data suggests improved survival with MN-166 and PD-1/PD-L1 antibody therapy combination. Future trials will evaluate this combination further.

MediciNova announced two poster presentations at the 92nd European Atherosclerosis Society (EAS) 2024 Congress. The presentations highlighted the efficacy, safety, and tolerability of MN-001 (Tipelukast) for non-alcoholic fatty liver disease (NAFLD) and its metabolite MN-002's effects on cholesterol efflux. The Phase 2 clinical trial for MN-001 has enrolled 33 patients, with 14 completing the study. Three serious adverse events were reported but deemed unrelated to the drug. MN-002 was shown to significantly enhance cholesterol efflux and protein expression in a dose-dependent manner, with notable increases in ABCA1 and ABCG1 mRNA levels.