1. MediciNova presented MN-166 trial data at an ALS symposium. 2. 234 participants completed the COMBAT-ALS Phase 2b/3 trial. 3. Baseline characteristics align with other ALS clinical studies. 4. Top-line results for MN-166 are expected by end of 2026. 5. MN-166 has FDA Orphan and Fast Track designations for ALS.
FAQ
Why Bullish?
The positive trial update and upcoming results may drive investor interest, following historical examples where successful trials in similar biopharma firms led to notable stock price increases.
How important is it?
The article discusses significant trial developments that are paramount for MNOV’s future performance.
Why Long Term?
Positive results in late-stage trials typically lead to sustained price increases over several months, as seen with companies like Biogen in ALS developments.
MediciNova (NASDAQ: MNOV) Presents Clinical Trial Updates at ALS/MND Symposium
On December 8, 2025, MediciNova, Inc. (NASDAQ: MNOV), a biopharmaceutical firm, shared significant updates regarding its Phase 2b/3 clinical trial of MN-166 (ibudilast) for treating Amyotrophic Lateral Sclerosis (ALS). This announcement came during the 36th International Symposium on ALS/MND, which took place from December 5-7, 2025, in San Diego, California.
Overview of the COMBAT-ALS Clinical Trial
The study, termed the COMBAT-ALS trial, focuses on the effectiveness of MN-166 in ALS treatment. Presented under the reference number CTL-21, the poster detailed critical components such as the trial’s purpose, scientific rationale, study design, and eligibility criteria.
Key Study Updates and Patient Demographics
According to the latest updates from MediciNova, a total of 234 participants have been randomized successfully, with enrollment concluding in September 2025. The study's baseline characteristics are as follows:
- Total randomized patients: 234 (Female: 86 [36.8%], Male: 148 [63.2%])
- Mean age at screening: 60.6 years
- Racial distribution: Caucasian (90.2%), Asian (5.1%), African American (1.3%), Native Hawaiian or Other Pacific Islander (0.4%), American Indian or Alaskan Native (0.4%), Other (2.6%)
- ALS onset type: Upper limb (46.2%), Lower limb (32.5%), Bulbar (20.9%), Unknown (0.4%)
- Mean ALSFRS-R score at screening: 40.6
- Mean disease duration from first symptom: 12.5 months
These demographic and clinical details align well with findings from other Phase 2 and Phase 3 trials, providing support for the broader insights these results may yield.
Expert Commentary on Trial Progress
Dr. Kazuko Matsuda, Chief Medical Officer of MediciNova, expressed gratitude towards the patients and families involved, emphasizing the challenges faced during the COVID-19 pandemic. She stated, “Achieving our randomization goal was not without challenges...but thanks to the dedication of investigators and study teams, we overcame these obstacles together. We anticipate top-line data by the end of 2026...”
Dr. Yuichi Iwaki, CEO of MediciNova, highlighted the company’s commitment to supporting patients wishing to continue treatment with MN-166 post-trial, through the FDA’s Individual Patient Expanded Access Program. He noted that MN-166 has received both Orphan Drug and Fast Track Designation from the FDA, underscoring its potential in ALS treatment.
About MN-166 (Ibudilast)
MN-166 (ibudilast) is a small molecule designed to inhibit phosphodiesterase type-4 (PDE4) and inflammatory cytokines. Presently, it is in late-stage clinical development not only for ALS but also for other neurodegenerative conditions, including progressive multiple sclerosis and degenerative cervical myelopathy. MN-166 is also undergoing evaluation for uses in glioblastoma, Long COVID, and treatment for chemotherapy-induced neuropathy.
About MediciNova
MediciNova, Inc. is actively developing a robust pipeline of small molecule therapies for treating various inflammatory and neurodegenerative diseases. With compounds like MN-166 and MN-001, the company is focusing on delivering innovative solutions for complex medical conditions.
Forward-Looking Statements
This announcement contains forward-looking statements regarding the future development and efficacy of MN-166. For a detailed examination of potential risks and uncertainties, stakeholders are advised to consult MediciNova's filings with the Securities and Exchange Commission.