Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MIS416 · 2 trials · 2 indications
Neuromuscular function will be assessed using the following test: * MS Function Composite (MSFC), comprising the; timed 25 Foot Walk, 9 Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test (PASAT); * Jebsen Hand Function Test (JHFT); * Grip, tip and key pinch strength; * Symbol digit modalities test (SDMT); * Sloan low-contrast letter visual acuity (SLCVA); * 6-minute walk test (6MWT);
Safety assessments will be conducted at each study visit and include; characterization of the type, incidence, severity, timing, seriousness, and relationship to treatment of adverse events (AEs); effects on vital signs and clinical laboratory parameters; changes on electrocardiograms (ECGs); and at 3 months and 12 months - the number of gadolinium-enhancing lesions on cranial MRI assessments.
Dose-limiting toxicities, adverse events, safety MRI assessments
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | 500 mcg MIS416 500 at 0.2 mg/mL administered i.v. once weekly for 52 weeks |
| Saline | PLACEBO_COMPARATOR | Saline administered i.v. once weekly for 52 weeks |
| MIS416 | EXPERIMENTAL | MIS416, immunomodulating microparticle, given intravenously weekly |
| Name | Type | Description |
|---|---|---|
| MIS416 | BIOLOGICAL | Intravenous administration weekly for 52 weeks |
| Saline | DRUG | Intravenous administration weekly for 52 weeks |
Inclusion Criteria: 1. A historical or current cranial MRI scan demonstrating T2-hyperintense lesions consistent with MS. 2. Has SPMS as determined by the 2010 Update to the McDonald Criteria 3. An Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 at Screening. 4. Has SPMS which, in the judgmen...
MIS416 is an investigational immunomodulating microparticle being studied for the treatment of Secondary Progressive Multiple Sclerosis (SPMS), a form of multiple sclerosis characterized by progressive disability. It has also been evaluated in Primary Progressive Multiple Sclerosis in an early-phase trial. It is not approved and remains in clinical development.
MIS416 is being developed by Innate Pharma S.A., a biopharmaceutical company listed on the stock exchange under the ticker IPHA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for progressive forms of multiple sclerosis.
MIS416 has completed a Phase 2 clinical trial for Secondary Progressive Multiple Sclerosis, following an earlier Phase 1 safety study. Both trials are completed, and the drug is not approved. It remains an investigational agent in clinical development.
MIS416 has been studied in two completed clinical trials. NCT01191996 was a Phase 1 safety study in progressive multiple sclerosis with 34 participants in New Zealand. NCT02228213 was a Phase 2 safety and efficacy trial in Secondary Progressive Multiple Sclerosis with 93 participants in Australia and New Zealand.
MIS416 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials for progressive forms of multiple sclerosis. The trials were placebo-controlled and double-blind, but the drug has not received regulatory approval and remains in clinical development.