In short
A new clinical trial is underway to investigate the safety and effectiveness of BIIB091, a potential treatment for relapsing forms of multiple sclerosis (MS). This study, known as FUSION, aims to evaluate BIIB091 both as a standalone therapy and in combination with diroximel fumarate (DRF). The trial focuses on assessing the drug's impact on brain inflammation and its overall safety profile in adults with relapsing MS.
At a glance
- Drug Name
- BIIB091
- Trial Name
- FUSION
- Condition
- Relapsing Forms of Multiple Sclerosis
- Trial Design
- 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study
- Primary Objectives
- 1. Investigate safety and tolerability of BIIB091 monotherapy; 2. Evaluate effects of BIIB091 + DRF combination therapy on MRI measures of CNS inflammation
- Key Inclusion Criteria
- - Diagnosis of RMS; - MS symptom onset < 20 years; - EDSS score 0-5.0; - Recent relapses or new MRI lesions
- Key Exclusion Criteria
- - Diagnosis of PPMS; - Recent MS relapse; - Severe allergic reactions to study treatments; - Certain infections (HIV, Hepatitis B/C)
- Primary Endpoints
- 1. Number of participants with adverse events; 2. Cumulative number of new T1 GdE lesions
- Treatment Duration
- Up to 48 weeks
- Maximum Daily Dose
- 700 mg
What is BIIB091?
BIIB091 is a new medication being studied for the treatment of relapsing forms of multiple sclerosis (MS). Its full chemical name is (R)-1-(TERT-BUTYL)-N-(8-(2-((1-METHYL-1H-PYRAZOL-4-YL)AMINO)PYRIMIDIN-4-YL)-2-(OXETAN-3-YL)-2,3,4,5-TETRAHYDRO-1H-BENZO[C]AZEPIN-5-YL)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE. This long name describes its unique chemical structure. For simplicity, we'll refer to it as BIIB091 throughout this article.
How BIIB091 Works
BIIB091 is classified as a small molecule drug. Small molecule drugs are typically able to enter cells easily due to their size. In the case of BIIB091, it's designed to target a specific protein in the body called Bruton's tyrosine kinase (BTK). BTK is involved in the immune system's response, and by targeting it, BIIB091 aims to reduce the harmful immune activity that occurs in multiple sclerosis.
Target Condition: Relapsing Forms of Multiple Sclerosis
BIIB091 is being developed to treat relapsing forms of multiple sclerosis (MS). This includes: Relapsing-remitting multiple sclerosis (RRMS): The most common form of MS, characterized by periods of new symptoms or relapses, followed by periods of recovery or remission. Active secondary progressive multiple sclerosis (SPMS): A form of MS that develops in some people with RRMS, where disability progressively worsens over time, with or without relapses. These forms of MS involve inflammation in the central nervous system (brain and spinal cord) that causes damage to the protective covering of nerve fibers, leading to various neurological symptoms.
Clinical Trial: FUSION Study
BIIB091 is currently being studied in a clinical trial called FUSION. This is a Phase 2 study, which means it's designed to test the drug's effectiveness and safety in a larger group of people with MS. The study has two parts: Part 1: Testing BIIB091 alone (monotherapy) Part 2: Testing BIIB091 in combination with another MS drug called Diroximel Fumarate (DRF) This approach allows researchers to understand how BIIB091 works on its own and how it might work together with an existing MS treatment.
Eligibility Criteria
To participate in the FUSION study, patients must meet certain criteria. Some key eligibility requirements include: Diagnosis of relapsing MS (RRMS or active SPMS) according to specific diagnostic criteria MS symptoms for less than 20 years An Expanded Disability Status Scale (EDSS) score between 0 and 5.0 (This scale measures the degree of disability in MS) Evidence of recent disease activity, such as relapses or new lesions on brain MRI scans There are also several conditions that would exclude a person from participating, such as having primary progressive MS, recent MS relapse, or certain other health conditions.
Study Objectives
The FUSION study aims to answer several important questions about BIIB091: Is BIIB091 safe and well-tolerated when used alone? How does BIIB091 affect brain inflammation when used alone? How does the combination of BIIB091 and DRF compare to DRF alone in reducing brain inflammation? Is the combination of BIIB091 and DRF safe and well-tolerated? To answer these questions, researchers will use various measures, including: MRI scans: To look for new or enlarging lesions in the brain, which are signs of active inflammation Adverse event monitoring: To track any side effects or safety concerns ECG measurements: To monitor heart activity and ensure the treatment doesn't cause heart-related issues
Safety Considerations
As with any new medication, safety is a top priority in the BIIB091 study. The researchers will closely monitor participants for any side effects or adverse reactions. Some specific safety considerations include: Allergic reactions: Participants with known allergies to BIIB091, DRF, or similar drugs are not eligible for the study Infections: The study excludes people with certain infections, including HIV and hepatitis B or C Heart monitoring: Regular ECG tests will be performed to check for any effects on heart rhythm It's important to note that while BIIB091 shows promise, it is still an experimental drug. More research is needed to fully understand its effectiveness and safety profile.