Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB091 · 6 trials · 3 indications
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
The formula used will be (Cmax-Cmin)/average concentration (Cavg) × 100.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Part 1: BIIB091 High Dose + Matching Placebo for DRF | EXPERIMENTAL | Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks. |
| Part 1: BIIB091 Low Dose + Matching Placebo for DRF | EXPERIMENTAL | Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks. |
| Part 1: DRF + Matching Placebo for BIIB091 | ACTIVE_COMPARATOR | Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks. |
| Part 2: BIIB091 + DRF Standard Dose | EXPERIMENTAL | Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks. |
| Part 2: BIIB091 + DRF Low Dose | EXPERIMENTAL | Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks. |
| Part 2: DRF + Matching Placebo for BIIB091 | ACTIVE_COMPARATOR | Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks. |
| BIIB091 IR | EXPERIMENTAL | Participants will receive BIIB091 IR tablets on Day 1 of its respective period, with food. |
| BIIB091 GR-slow | EXPERIMENTAL | Participants will receive BIIB091 GR-slow tablets on Day 1 of its respective period, with food. |
| BIIB091 GR-fast | EXPERIMENTAL | Participants will receive BIIB091 GR-fast tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-slow | EXPERIMENTAL | Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-fast | EXPERIMENTAL | Participants will receive BIIB091 ER-fast tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-slow Fasted | EXPERIMENTAL | Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, without food. |
| BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo | EXPERIMENTAL | Participants will receive BIIB091, BIIB091-matched placebo, and moxifloxacin-matched placebo orally during the inpatient period (Days -1 to 13). |
| Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo | ACTIVE_COMPARATOR | Participants will receive moxifloxacin, moxifloxacin-matched placebo, and BIIB091-matched placebo orally during the inpatient period (Days -1 to 13). |
| [14C]-BIIB091 | EXPERIMENTAL | Participants will receive a single oral dose of \[14C\]-BIIB091 on Day 1. |
| Part 1 | EXPERIMENTAL | Participants will receive single oral dose of BIIB091 on Day 1 of each study period, in fasted state, for up to 5 periods. There will be a minimum 7-day washout between Day 1 of each study period. |
| Part 1B | EXPERIMENTAL | Participants will be randomized to receive single oral or 2 oral doses for divided daily doses of BIIB091 on Day 1 of Period 1, in fasted state or single oral dose of BIIB091 on Day 1 of Period 1, in fed state. Participants will receive single oral dose of BIIB091 on Day 1 of Period 2, in fasted state. Participants will receive single or two divided oral dose(s) of BIIB091 on Day 1 of Periods 3 and 4, in fasted or fed state. There will be a minimum 7-day washout between Day 1 of each study period. |
| Part 2 | EXPERIMENTAL | Participants will receive single oral dose of BIIB091 on Day (D) 1 of Period (P) 1 in fasted/fed state; then itraconazole 100 milligram (mg) capsules (cap), orally, twice daily (BID) for 1 day (D -4) of P2, in fed state; then itraconazole 100 mg cap, orally, once daily (QD) for 2 days (D -3, -2) of P2, in fed state; then itraconazole 100 mg cap, orally, QD for 1 day (D -1) of P2, in fasted/fed state; then combination of itraconazole 100 mg cap, orally and BIIB091, orally on 5th day (D 1) of P2, in fasted/fed state; then itraconazole 100 mg cap, orally on 6th day (D 2) of P2, in fed state; then rabeprazole 20 mg tablets (tab), orally, BID for 3 days (D -3, -2, and -1) of P3 in fed state; then combination of rabeprazole 20 mg tab, orally and BIIB091, orally, on 4th day (D 1) of P3 in fasted/fed state. Minimum 7-day washout between dose of BIIB091 in P1 and 1st dose of itraconazole in P2; minimum 10-day washout between final dose of itraconazole in P2 and 1st dose of rabeprazole in P3. |
| Part 3 | EXPERIMENTAL | Participants will receive BIIB091, orally, QD or BID for at least 7 days in fasted or fed state. |
| Single Ascending Dose (SAD): Cohort 1A | EXPERIMENTAL | Participants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 2A | EXPERIMENTAL | Participants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 3A | EXPERIMENTAL | Participants will receive dose level 3 of BIIB091 or placebo, orally, while fasting on Day 1, then again following a 7 day washout and high-fat meal. |
| (SAD): Cohort 4A | EXPERIMENTAL | Participants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 5A | EXPERIMENTAL | Participants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1. |
| Multiple Ascending Dose (MAD): Cohort 1B | EXPERIMENTAL | Participants will receive dose level 1 of BIIB091 or placebo, orally, twice daily (BID) for 13 days, and a single dose on Day 14. |
| (MAD): Cohort 2B | EXPERIMENTAL | Participants will receive dose level 2 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. |
| (MAD): Cohort 3B | EXPERIMENTAL | Participants will receive dose level 3 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. |
| Name | Type | Description |
|---|---|---|
| BIIB091 | DRUG | Administered as specified in the treatment arm. |
| DRF | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
| Moxifloxacin | DRUG | Administered as specified in the treatment arm. |
| BIIB091-matched Placebo | DRUG | Administered as specified in the treatment arm. |
| Moxifloxacin-matched Placebo | DRUG | Administered as specified in the treatment arm. |
| [14C]-BIIB091 | DRUG | Administered as specified in the treatment arm. |
| Rabeprazole | DRUG | Administered as specified in the treatment arm |
| Itraconazole | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: 1. Diagnosis of RMS \[relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)\] in accordance with the 2017 Revised McDonald criteria. 2. Time since MS symptom onset is \<20 years. 3. Must have expanded disability status scale ...
BIIB091 is an investigational small molecule being studied for relapsing forms of multiple sclerosis (MS). It has also been evaluated in healthy volunteers for safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved and remains in clinical development.
BIIB091 is a Bruton's tyrosine kinase (BTK) inhibitor. BTK is an enzyme involved in B-cell and macrophage signaling, which are implicated in the inflammatory processes of multiple sclerosis. By inhibiting BTK, BIIB091 may reduce brain inflammation associated with the disease.
BIIB091 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical trials to evaluate the safety and efficacy of BIIB091 in healthy volunteers and in patients with relapsing forms of multiple sclerosis.
BIIB091 is in Phase 1 clinical development. While one trial listed under the drug is labeled Phase 2, the overall development stage is Phase 1, with all four studies completed. BIIB091 is investigational and has not been approved by regulatory authorities.
BIIB091 has completed four clinical trials. NCT03943056 and NCT06574828 evaluated safety and heart effects in healthy volunteers, while NCT06640933 studied how different forms are processed with and without food. NCT05798520, a Phase 2 study, assessed safety and brain inflammation in adults with relapsing MS when taken alone or with diroximel fumarate.
No, BIIB091 is not the same as diroximel fumarate. BIIB091 is a Bruton's tyrosine kinase inhibitor, while diroximel fumarate is a separate medication. In clinical trials, BIIB091 has been studied alone and in combination with diroximel fumarate to assess its effects on brain inflammation in multiple sclerosis.