MediciNova Completes Patient Enrollment in OXTOX Study
MediciNova completed patient enrollment in the Phase 2 clinical trial, the OXTOX study - Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer -. This study is evaluating MN-166 - ibudilast - for the prevention of chemotherapy-induced peripheral neuropathy in patients with metastatic colorectal cancer. A total of 100 patients have been randomized across two treatment arms at 11 clinical sites in Australia. Patient recruitment is now officially closed. Study participants will continue chemotherapy along with the assigned study drug, MN-166 or placebo, until disease progression or unacceptable side effects. The study will conclude when the final patient reaches six months post-chemotherapy. While the exact study completion date is not yet determined, the company anticipates that top-line data may be available later in 2026. For the amyotrophic lateral sclerosis indication, MediciNova has Orphan Drug Designation& Fast Track Status from the FDA and Orphan Drug Designation from the EMA.
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- 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.
- 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.

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.

- Clinical Trial Progress: MediciNova has successfully enrolled 100 patients across 11 clinical sites in Australia for the OXTOX study, which evaluates MN-166's efficacy in preventing chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients, highlighting the company's ongoing commitment to neurodegenerative disease research.
- Study Design: This randomized, placebo-controlled Phase 2 trial allows participants to continue chemotherapy while receiving either MN-166 or a placebo, with the study expected to conclude six months post-chemotherapy, providing critical efficacy data for future development.
- Future Data Expectations: While the exact completion date is not yet determined, top-line data is anticipated to be available later in 2026, which will provide essential insights for MN-166's further development and could significantly impact its market prospects.
- Drug Background: MN-166 is a small molecule compound with multiple mechanisms of action, currently in late-stage clinical development for various neurodegenerative diseases, and has received Orphan Drug Designation and Fast Track Status from the FDA, indicating its potential in the market.

- Clinical Trial Progress: MediciNova has successfully completed patient enrollment of 100 individuals across 11 clinical sites in Australia for the OXTOX study, marking a significant advancement in research targeting chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients.
- Study Design: This randomized, placebo-controlled Phase 2 clinical trial aims to evaluate the efficacy of MN-166 (ibudilast) in chemotherapy patients, which is expected to provide critical data for future treatment options.
- Data Expectations: While the exact completion date of the study is not yet determined, top-line data is anticipated to be available in 2026, which will support further development and market potential for MN-166.
- Drug Background: MN-166, a small molecule compound with multiple mechanisms of action, has demonstrated a strong safety profile in clinical development for various neurodegenerative diseases, indicating its broad application prospects in the treatment landscape.
- Clinical Trial Progress: MediciNova has completed randomization of 234 participants in the COMBAT-ALS study, overcoming recruitment challenges during the COVID-19 pandemic, with top-line data expected by the end of 2026, potentially representing a significant therapeutic advance for ALS patients.
- Patient Demographics: Among participants, 36.8% were female and 63.2% male, with a mean age of 60.6 years and a racial distribution of 90.2% Caucasian, aligning with other ALS trials and enhancing the generalizability of the study findings.
- Drug Development Support: MediciNova is actively supporting patients wishing to continue MN-166 treatment through the FDA’s Individual Patient Expanded Access Program, demonstrating the company's commitment to ALS patients, with MN-166 receiving Orphan Drug and Fast Track Designation.
- Future Development Plans: The company is closely collaborating with experienced regulatory experts to prepare for the next steps in advancing MN-166, aiming to address uncertainties and risks in clinical trials to ensure smooth drug development.







