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MN-166 · 5 trials · 6 indications
The amyotrophic lateral sclerosis functional rating scale-revised, or ALSFRS-R, measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points.
Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs and Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations.
Compare the maximum plasma concentrations (Cmax) of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers.
Cmax of MN-166 (ibudilast) of ER 50 mg tablet and IR 10 mg capsule (5 capsules) formulations, in a single-dose regimen in healthy volunteers fed a high-fat meal 1 hour prior to dosing or fasted 8 hours prior to dosing.
Determine the proportion of patients with * Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and * Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).
Proportion of patients who are progression free at 6 months (PFS6) using the RANO criteria.
Compare the maximum plasma concentrations \[Cmax\] of MN-166 of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers.
| Arm | Type | Description |
|---|---|---|
| MN-166 | EXPERIMENTAL | Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months. |
| placebo | PLACEBO_COMPARATOR | Subjects will take up to 5 matching placebo capsules twice a day for 12 months. |
| Placebo (for MN-166) | PLACEBO_COMPARATOR | Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months. |
| Sequence 1 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 1 comprising 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: ER fed Day 15-22: IR fasted |
| Sequence 2 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 2 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: IR fasted; Day 15-22: ER fasted |
| Sequence 3 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 3 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fasted; Day 15-22: ER fed |
| Sequence 4 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 4 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: IR fasted; Day 8-15: ER fed; Day 15-22: ER fasted |
| Sequence 5 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 5 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fasted; Day 8-15: IR fasted; Day 15-22: ER fed |
| Sequence 6 | ACTIVE_COMPARATOR | Two participants will be randomly assigned to sequence 6 comprising 3 treatments in a crossover design, administered one week apart: Day 1-7: ER fed; Day 8-15: ER fasted; Day 15-22: IR fasted |
| MN-166 and temozolomide | EXPERIMENTAL | Part 1: Combination treatment of MN-166 60 mg/day (30 mg twice a day) for 28 days and temozolomide 150 mg/m² on Days 1-5 of 28-day cycle. Part 2: Open-label, fixed-dose MN-166 and temozolomide combination treatment for 6 cycles until disease progression, unacceptable tolerability and/or toxicity or loss of life. |
| Extended-release formulation 1 (ER1) | EXPERIMENTAL | 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
| Extended-release formulation 2 (ER2) | EXPERIMENTAL | 50mg MN-166 tablet. This formulation is intended for once-a-day dosing, hence, the label of extended-release. |
| Intermediate-release formulation (IR) | ACTIVE_COMPARATOR | 10mg MN-166 capsule. This formulation is typically given two or three times daily, hence, the label of intermediate-release. |
| Name | Type | Description |
|---|---|---|
| MN-166 | DRUG | Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase. |
| placebo | DRUG | Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase. |
| Placebo (for MN-166) | DRUG | - |
| riluzole | DRUG | Patient is given 50 mg riluzole twice daily. |
| Temozolomide | DRUG | Temozolomide is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; and a first-line treatment for glioblastoma multiforme. |
Major Inclusion Criteria: * Male or female subjects age 18 - 80 years, inclusive; * Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS \[clinically definite, clinically probable, probable-laboratory-supported\]; * ALS onset of ≤18...
MN-166 (ibudilast) is an investigational small molecule being studied for amyotrophic lateral sclerosis (ALS), glioblastoma, and healthy volunteer pharmacokinetic studies. It is in Phase 2 clinical development for ALS and has received orphan drug and fast track designations from the FDA.
MN-166 (ibudilast) is a small molecule that inhibits phosphodiesterase-4 (PDE4) and macrophage migration inhibitory factor (MIF), which are involved in neuroinflammation. This mechanism is being evaluated in conditions like ALS and glioblastoma, where inflammatory pathways contribute to disease progression.
MN-166 (ibudilast) is being developed by MediciNova, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol MNOV. The company is conducting clinical trials of MN-166 in the United States and Canada.
MN-166 (ibudilast) is in Phase 2 clinical development for amyotrophic lateral sclerosis (ALS), with an active Phase 2 trial (NCT04057898) that is not yet recruiting. It has also completed Phase 1 trials in healthy volunteers and glioblastoma patients. It is not FDA approved and remains investigational.
MN-166 (ibudilast) has four clinical trials listed on ClinicalTrials.gov. The active Phase 2 trial is NCT04057898, evaluating MN-166 for 12 months with a 6-month open-label extension in ALS patients. Completed Phase 1 trials include NCT03533387, NCT03782415, and NCT04054206, covering healthy volunteer formulations and glioblastoma combination therapy.
Yes, MN-166 is the same as ibudilast. The drug is referred to by both names in clinical trial records, with MN-166 being the development code used by MediciNova and ibudilast being the generic name. Both names refer to the same investigational small molecule.