Approval Probability
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Also known as IMU-838 tablets, vidofludimus calcium
IMU-838 · 4 trials · 4 indications
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
Number of Participants Stratified as those With and Without the Need for INV Until End-of-study (EoS). For this outcome a worst case approach was used in which patients who were lost to follow-up or who discontinued the trial on or before Day 13 due to any other reason than death and discontinued with a last observed WHO clinical status no lower than that at Screening, and patients who died were considered as patients requiring INV.
MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of gadolinium enhancing (Gd+) lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. Mainly due to the differing number of patients with 3.0 Tesla MRI examinations in each treatment arm, the statistical adjustments (to ensure comparabiltiy) for each individual comparison differed and hence the adjusted mean cumulative number of CUA MRI lesions in each arm (e.g. placebo) differed depending on the comparison (45 mg IMU-838 vs placebo, 30 mg IMU-838 vs placebo, or 45 mg vs 30 mg IMU-838).
| Arm | Type | Description |
|---|---|---|
| IMU-838 | EXPERIMENTAL | IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, as described for the test product, identical number of tablets as given for IMU-838. |
| IMU-838 (30 mg/day) | EXPERIMENTAL | IMU-838 tablet containing 15 mg Vidofludimus calcium (IM90838). Once-daily oral dose of 30 mg consists of 2 tablets IMU-838. Duration: until the end of the main treatment period (24 weeks). In the optional extended treatment period, patients were randomized to receive either 30 mg/day or 45 mg/day IMU-838 (up to 9.5 years for the main trial). |
| IMU-838 (45 mg/day) | EXPERIMENTAL | Tablet containing 22.5 mg Vidofludimus calcium (IM90838). Once-daily oral dose of 45 mg consists of 2 tablets. Duration: until the end of the main treatment period (24 weeks). In the optional extended treatment period, patients were randomized to receive either 30 mg/day or 45 mg/day IMU-838. |
| IMU-838 (10 mg/day) - Cohort 2 | EXPERIMENTAL | Cohort 2 sub-trial: additional sub-trial with a small double-blind, placebo-controlled, randomized, parallel-group assessment of a low IMU-838 dose (i.e. 10 mg/day) to provide additional data for pharmacodynamic modelling. Tablet containing 5 mg Vidofludimus calcium (IM90838). Once-daily oral dose of 10 mg consists of 2 tablets. Duration: until the end of the main treatment period (24 weeks). In the optional extended treatment period, patients were randomized to receive either 30 mg/day or 45 mg/day IMU-838 (up to 8.5 years for the cohort 2 sub-trial). |
| Name | Type | Description |
|---|---|---|
| IMU-838 tablets | DRUG | Patients are randomized to IMU-838 or placebo in ratio 1:1 |
| Placebo matching IMU-838 tablets | DRUG | Patients are randomized to IMU-838 or placebo in ratio 1:1 |
| IMU-838 | DRUG | Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. |
| Placebo | OTHER | Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| IMU-838 (30 mg/day) | DRUG | * Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 15 mg tablet IMU-838 daily) and then start taking the full assigned dose from Day 7 onwards (two 15 mg tablets IMU-838 once daily). * Optional extended treatment period (optional): Participants who were re-randomized to a 30 mg/day dose will take the full assigned dose which consists of two 15 mg tablets IMU-838 once daily. |
| IMU-838 (45 mg/day) | DRUG | * Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 22.5 mg tablet per day) and then start taking the full assigned dose from Day 7 onwards (two 22.5 mg tablets once daily). * Optional extended treatment period (optional): Participants who were re-randomized to a 45 mg/day dose will take the full assigned dose of two 22.5 mg tablets IMU-838 once daily. |
| IMU-838 (10 mg/day) | DRUG | * Main treatment period for Cohort 2: All patients will receive half the assigned dose during the first 7 days of the main treatment period (one 5 mg tablet per day) and then start taking the full assigned dose from Day 7 onwards (two 5 mg tablets once daily). * Optional extended treatment period (not applicable to Cohort 2): IMU-838 10 mg/day not applicable. |
Inclusion Criteria: * Male or female patient (age ≥18 to ≤55 years). * Patients with an established diagnosis of MS according to 2017 McDonald Criteria. * Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 199...
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IMU-838 is an investigational oral small molecule developed by Immunic, Inc. (ticker IMUX) for immune-mediated and viral diseases. It is being studied in relapsing-remitting multiple sclerosis and was studied in COVID-19. It is not approved and remains in clinical development.
IMU-838 is being developed for relapsing-remitting multiple sclerosis, including Phase 3 trials in that indication. It was also studied in COVID-19 as an addition to investigator's choice of standard of care therapy. It is investigational and not approved for any use.
IMU-838 targets Nurr1, a nuclear receptor. By acting on this target, the small molecule is designed to modulate immune cell metabolism and function, which is the basis for its development in immune-mediated conditions such as relapsing-remitting multiple sclerosis.
IMU-838 is developed by Immunic, Inc., which trades under the ticker IMUX. Immunic is the sponsor of the clinical program evaluating the drug in relapsing-remitting multiple sclerosis and COVID-19.
IMU-838 is in Phase 3 development for relapsing-remitting multiple sclerosis, with two active Phase 3 trials. A Phase 2 trial in COVID-19 has been completed, and a Phase 2 MRI trial in relapsing-remitting multiple sclerosis is active. The drug is investigational and not approved.
IMU-838 is being studied in Phase 3 trials NCT05201638 and NCT05134441 in relapsing-remitting multiple sclerosis, both active and not recruiting. The Phase 2 EMPhASIS MRI trial NCT03846219 is also active, and the Phase 2 COVID-19 trial NCT04379271 is completed.
Yes. IMU-838 tablets and IMU-838 (30 mg/day) refer to the same investigational drug from Immunic, Inc. The 30 mg/day designation describes the dose studied in clinical trials, and the tablets are the oral formulation used in those studies.