MediciNova Completes Last Patient Visit in Phase 2 Trial of MN-001
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Source: NASDAQ.COM
- Clinical Trial Progress: MediciNova announced the completion of the last patient visit in its Phase 2 trial of MN-001 for treating hypertriglyceridemia and non-alcoholic fatty liver disease in type-2 diabetes patients, marking a significant milestone in the drug's development.
- Trial Design and Objectives: The trial is a multicenter, randomized, double-blind, placebo-controlled study lasting 24 weeks, primarily assessing the impact of MN-001 on liver fat content and serum triglycerides, with topline results expected in Q3 2026, potentially influencing treatment strategies for diabetes-related conditions.
- Drug Mechanism and Potential: MN-001 is a novel small molecule compound exhibiting anti-inflammatory and anti-fibrotic activity by inhibiting fibrosis pathways and down-regulating pro-inflammatory genes, showing promising results in preclinical models, which could provide new treatment options for diabetic patients if successful.
- Other R&D Updates: In addition to MN-001, MediciNova is advancing Phase 2 trials for idiopathic pulmonary fibrosis and non-alcoholic fatty liver disease, while its lead candidate MN-166 is undergoing Phase 3 studies for amyotrophic lateral sclerosis and other conditions, demonstrating the company's diversified strategy in the biopharmaceutical sector.
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About MNOV
MediciNova, Inc. is a biopharmaceutical company that is developing therapeutics with a primary focus on neurology, respiratory and liver diseases. The Company's development activities are focused on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (methamphetamine dependence, opioid dependence and alcohol dependence), prevention of acute respiratory distress syndrome, and Long COVID, and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease and hypertriglyceridemia. Its MN-166 (ibudilast) is a first-in-class, oral, anti-inflammatory and neuroprotective agent. The FDA has granted Fast Track designations to MN-166 (ibudilast) for three separate indications: progressive MS, ALS, and methamphetamine dependence.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
MediciNova Completes Last Patient Visit in Phase 2 Trial of MN-001
- Clinical Trial Progress: MediciNova announced the completion of the last patient visit in its Phase 2 trial of MN-001 for treating hypertriglyceridemia and non-alcoholic fatty liver disease in type-2 diabetes patients, marking a significant milestone in the drug's development.
- Trial Design and Objectives: The trial is a multicenter, randomized, double-blind, placebo-controlled study lasting 24 weeks, primarily assessing the impact of MN-001 on liver fat content and serum triglycerides, with topline results expected in Q3 2026, potentially influencing treatment strategies for diabetes-related conditions.
- Drug Mechanism and Potential: MN-001 is a novel small molecule compound exhibiting anti-inflammatory and anti-fibrotic activity by inhibiting fibrosis pathways and down-regulating pro-inflammatory genes, showing promising results in preclinical models, which could provide new treatment options for diabetic patients if successful.
- Other R&D Updates: In addition to MN-001, MediciNova is advancing Phase 2 trials for idiopathic pulmonary fibrosis and non-alcoholic fatty liver disease, while its lead candidate MN-166 is undergoing Phase 3 studies for amyotrophic lateral sclerosis and other conditions, demonstrating the company's diversified strategy in the biopharmaceutical sector.
See More
MediciNova Completes Last Patient Visit in MN-001 Clinical Trial
- Clinical Trial Progress: MediciNova announced the completion of the last patient visit in its Phase 2 clinical trial MN-001-NATG-202 for MN-001 (tipelukast) targeting hypertriglyceridemia and nonalcoholic fatty liver disease associated with type 2 diabetes, marking a significant milestone as the study moves into critical data analysis, with top-line results expected in Q3 2026, potentially impacting the company's future market performance positively.
- Trial Design Details: The study is a multicenter, randomized, double-blind, placebo-controlled trial where patients are randomized 1:1 to receive either 500 mg/day of MN-001 or placebo for 24 weeks, primarily assessing changes in liver fat content and fasting serum triglycerides, which will provide crucial evidence for the efficacy of MN-001.
- Drug Mechanism Exploration: MN-001 is believed to exert anti-inflammatory and antifibrotic effects through various mechanisms, including leukotriene receptor antagonism and phosphodiesterase inhibition, with research indicating its ability to down-regulate genes promoting fibrosis and inflammation; positive clinical outcomes could offer new treatment options and enhance the company's competitive edge in the biopharmaceutical sector.
- Market Potential Analysis: Given the high prevalence of hypertriglyceridemia and NAFLD among type 2 diabetes patients, successful development of MN-001 could not only improve patient quality of life but also open new revenue streams for MediciNova, further solidifying its position in the biopharmaceutical industry.
See More
MediciNova Study Reveals New Target for Brain Metastasis
- New Target Discovery: Research from the Spanish National Cancer Research Centre identifies macrophage migration inhibitory factor (MIF)-mediated reprogramming of CD74-positive microglia and macrophages as a central vulnerability in brain metastasis, highlighting the therapeutic potential of pharmacological modulation of the MIF-CD74 signaling pathway.
- Efficacy of Ibudilast: The study demonstrates that ibudilast effectively blocks MIF-CD74 signaling, reverses pro-metastatic immune reprogramming, and suppresses brain metastasis growth in preclinical systems, potentially offering new strategies for neuro-oncology treatments.
- Biomarker Potential: The research also identifies secreted MIF as a candidate liquid biopsy biomarker detectable in cerebrospinal fluid, supporting biomarker-guided clinical strategies that could enhance treatment outcomes for patients with brain metastases.
- Future Clinical Collaboration: MediciNova plans to collaborate with Dr. Valiente and CNIO on clinical research targeting patients with brain metastases, aiming to address significant unmet medical needs, particularly for common metastatic cancers such as lung and breast cancer.
See More
MediciNova's SEANOBI Study Reaches 50% Enrollment Milestone
- Study Progress: MediciNova's SEANOBI study has enrolled 50% of its target 200 participants, indicating significant clinical research advancement in ALS, which may provide new treatment options for patients.
- Funding Support: The study is backed by a $22 million NIH grant aimed at accelerating access to therapies for ALS patients, reflecting government commitment to this research area and confidence in MediciNova.
- Clinical Trials: The ongoing COMBAT ALS trial for MN-166 has enrolled 234 patients, with top-line results expected by the end of 2026, which will provide critical efficacy data that could influence future market performance.
- Drug Development: In addition to ALS, MN-166 is being developed for glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy, and substance use disorder, showcasing its broad potential indications that could diversify the company's revenue streams.
See More
MediciNova Activates SEANOBI Study with 100 Patient Enrollments
- Patient Enrollment Progress: As of the end of January 2026, MediciNova has successfully enrolled 100 ALS patients across 12 sites in the U.S., achieving 50% of the planned 200 enrollments, marking significant progress in the clinical development of MN-166 and potentially accelerating the drug approval process.
- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
See More
Biotech Surge Post-Market: Inspira, MediciNova, and DiaMedica Therapeutics Among Top Performers
Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
See More
MediciNova Completes Last Patient Visit in Phase 2 Trial of MN-001
- Clinical Trial Progress: MediciNova announced the completion of the last patient visit in its Phase 2 trial of MN-001 for treating hypertriglyceridemia and non-alcoholic fatty liver disease in type-2 diabetes patients, marking a significant milestone in the drug's development.
- Trial Design and Objectives: The trial is a multicenter, randomized, double-blind, placebo-controlled study lasting 24 weeks, primarily assessing the impact of MN-001 on liver fat content and serum triglycerides, with topline results expected in Q3 2026, potentially influencing treatment strategies for diabetes-related conditions.
- Drug Mechanism and Potential: MN-001 is a novel small molecule compound exhibiting anti-inflammatory and anti-fibrotic activity by inhibiting fibrosis pathways and down-regulating pro-inflammatory genes, showing promising results in preclinical models, which could provide new treatment options for diabetic patients if successful.
- Other R&D Updates: In addition to MN-001, MediciNova is advancing Phase 2 trials for idiopathic pulmonary fibrosis and non-alcoholic fatty liver disease, while its lead candidate MN-166 is undergoing Phase 3 studies for amyotrophic lateral sclerosis and other conditions, demonstrating the company's diversified strategy in the biopharmaceutical sector.
See More
MediciNova Completes Last Patient Visit in MN-001 Clinical Trial
- Clinical Trial Progress: MediciNova announced the completion of the last patient visit in its Phase 2 clinical trial MN-001-NATG-202 for MN-001 (tipelukast) targeting hypertriglyceridemia and nonalcoholic fatty liver disease associated with type 2 diabetes, marking a significant milestone as the study moves into critical data analysis, with top-line results expected in Q3 2026, potentially impacting the company's future market performance positively.
- Trial Design Details: The study is a multicenter, randomized, double-blind, placebo-controlled trial where patients are randomized 1:1 to receive either 500 mg/day of MN-001 or placebo for 24 weeks, primarily assessing changes in liver fat content and fasting serum triglycerides, which will provide crucial evidence for the efficacy of MN-001.
- Drug Mechanism Exploration: MN-001 is believed to exert anti-inflammatory and antifibrotic effects through various mechanisms, including leukotriene receptor antagonism and phosphodiesterase inhibition, with research indicating its ability to down-regulate genes promoting fibrosis and inflammation; positive clinical outcomes could offer new treatment options and enhance the company's competitive edge in the biopharmaceutical sector.
- Market Potential Analysis: Given the high prevalence of hypertriglyceridemia and NAFLD among type 2 diabetes patients, successful development of MN-001 could not only improve patient quality of life but also open new revenue streams for MediciNova, further solidifying its position in the biopharmaceutical industry.
See More
MediciNova Study Reveals New Target for Brain Metastasis
- New Target Discovery: Research from the Spanish National Cancer Research Centre identifies macrophage migration inhibitory factor (MIF)-mediated reprogramming of CD74-positive microglia and macrophages as a central vulnerability in brain metastasis, highlighting the therapeutic potential of pharmacological modulation of the MIF-CD74 signaling pathway.
- Efficacy of Ibudilast: The study demonstrates that ibudilast effectively blocks MIF-CD74 signaling, reverses pro-metastatic immune reprogramming, and suppresses brain metastasis growth in preclinical systems, potentially offering new strategies for neuro-oncology treatments.
- Biomarker Potential: The research also identifies secreted MIF as a candidate liquid biopsy biomarker detectable in cerebrospinal fluid, supporting biomarker-guided clinical strategies that could enhance treatment outcomes for patients with brain metastases.
- Future Clinical Collaboration: MediciNova plans to collaborate with Dr. Valiente and CNIO on clinical research targeting patients with brain metastases, aiming to address significant unmet medical needs, particularly for common metastatic cancers such as lung and breast cancer.
See More
MediciNova's SEANOBI Study Reaches 50% Enrollment Milestone
- Study Progress: MediciNova's SEANOBI study has enrolled 50% of its target 200 participants, indicating significant clinical research advancement in ALS, which may provide new treatment options for patients.
- Funding Support: The study is backed by a $22 million NIH grant aimed at accelerating access to therapies for ALS patients, reflecting government commitment to this research area and confidence in MediciNova.
- Clinical Trials: The ongoing COMBAT ALS trial for MN-166 has enrolled 234 patients, with top-line results expected by the end of 2026, which will provide critical efficacy data that could influence future market performance.
- Drug Development: In addition to ALS, MN-166 is being developed for glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy, and substance use disorder, showcasing its broad potential indications that could diversify the company's revenue streams.
See More
MediciNova Activates SEANOBI Study with 100 Patient Enrollments
- Patient Enrollment Progress: As of the end of January 2026, MediciNova has successfully enrolled 100 ALS patients across 12 sites in the U.S., achieving 50% of the planned 200 enrollments, marking significant progress in the clinical development of MN-166 and potentially accelerating the drug approval process.
- Funding Support: The SEANOBI Expanded Access Program is backed by a $22 million NINDS grant, designed to provide MN-166 treatment access to ALS patients not eligible for ongoing randomized trials while collecting crucial clinical and biomarker data, enhancing the drug's market competitiveness.
- Clinical Trial Design: MN-166 is also undergoing the COMBAT-ALS Phase 2b/3 randomized controlled trial, with 234 patients enrolled in the U.S. and Canada, and top-line results expected by the end of 2026, which will provide essential evidence for the drug's future approval.
- Strategic Implications: MediciNova's MN-166 has received Orphan Drug Designation from the FDA and EMA, along with Fast Track Designation from the FDA, and the combined clinical data from SEANOBI and COMBAT-ALS will offer more treatment options for ALS patients, addressing the urgent market demand for new therapies.
See More
Biotech Surge Post-Market: Inspira, MediciNova, and DiaMedica Therapeutics Among Top Performers
Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.
Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.
MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.
DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.
See More
