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BIIB104

Phase 2

Cognitive Impairment Associated With Schizophrenia | Small molecule | Psychiatry |Biogen Inc.|Last Updated: Apr 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

Clinical trial landscape

BIIB104 · 5 trials · 3 indications

Phase 2 1Phase 1 4
NCT03745820A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)Cognitive Impairment Associated With Schizophrenia
COMPLETED195 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Cognitive Impairment Associated With Schizophrenia
NCT03745820195
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Study Endpoints

Primary Endpoints

Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12
Baseline and Week 12

The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure.

Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
Up to Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
Up to Day 6
Maximum Observed Plasma Concentration (Cmax) of BIIB104
Up to Day 6
Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
Up to Day 6
Maximum Observed Concentration (Cmax) of BIIB104
Up to Day 11
Time to Reach Maximum Observed Concentration (Tmax) of BIIB104
Up to Day 11
Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104
Up to Day 11
Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104
Up to Day 11
Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104
Up to Day 11
Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104
Up to Day 11
Apparent Total Body Clearance (CL/F) of BIIB104
Up to Day 11
Apparent Volume of Distribution (Vz/F) of BIIB104
Up to Day 11
Elimination Half-Life (t½) of BIIB104
Up to Day 11
Accumulation Ratio for Steady State of BIIB104
Up to Day 11

Accumulation ratio for steady state is defined as area under the concentration-time curve over a uniform dosing interval tau at steady state divided by area under the concentration-time curve within a dosing interval for single dose \[AUC(tau,ss)/AUC(tau,sd)\].

Trough Concentration (Ctrough) of BIIB104
Up to Day 11
Change From Baseline in Faces Versus Shapes Emotional Faces Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 4 Within a Priori Defined Regions of Interest
Baseline, Day 4
Maximum Observed Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Time to Reach Maximum Observed Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Maximum Observed Concentration at Steady State of BIIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Time to Reach Maximum Observed Concentration at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Apparent Total Body Clearance of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Apparent Volume of Distribution of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Elimination Half-Life of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Accumulation Ratio at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Trough Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

Secondary Endpoints

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From first dose of study drug through end of the study (up to Week 14)
Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA)
Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14)
Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Up to Week 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB104 0.5 mgEXPERIMENTALParticipants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks.
BIIB104 0.15 mgEXPERIMENTALParticipants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks.
Matching PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo twice a day, orally, for 12 weeks.
BIIB104 0.5 mg Reference Formulation (Fasted State)ACTIVE_COMPARATORParticipants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.
BIIB104 0.5 mg Test Formulation (Fasted State)EXPERIMENTALParticipants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state.
BIIB104 0.5 mg Test Formulation (Fed State)EXPERIMENTALParticipants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.
BIIB104: Dose 1EXPERIMENTALJapanese and non-Japanese participants will receive BIIB104, Dose 1, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.
BIIB104: Dose 2EXPERIMENTALJapanese and non-Japanese participants will receive BIIB104, Dose 2, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.
PlaceboPLACEBO_COMPARATORJapanese and non-Japanese participants will receive BIIB104-matching placebo, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.
BIIB104EXPERIMENTALParticipants will receive BIIB104 on Days 1-4 in treatment periods 1 or 2.

Interventions

NameTypeDescription
BIIB104DRUGAdministered as specified in the treatment arm
PlaceboOTHERAdministered as specified in the treatment arm
BIIB104 Reference FormulationDRUGAdministered as specified in the treatment arm
BIIB104 Test FormulationDRUGAdministered as specified in the treatment arm
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites60

Key Inclusion Criteria: * Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorder...

Countries:United StatesGermanyJapanSpainUnited Kingdom
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Frequently asked questions about BIIB104

What is BIIB104 used for?

BIIB104 is an investigational small molecule being developed by Biogen for cognitive impairment associated with schizophrenia. It is also studied in healthy volunteers for early-phase trials. The drug is currently in Phase 2 clinical development, though all listed trials are completed Phase 1 studies.

Who makes BIIB104?

BIIB104 is developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen is conducting clinical trials of BIIB104 in healthy volunteers and for cognitive impairment associated with schizophrenia.

What phase is BIIB104 in?

BIIB104 is in Phase 2 clinical development for cognitive impairment associated with schizophrenia. The completed trials listed are Phase 1 studies in healthy volunteers, which have finished. BIIB104 is investigational and not yet approved by regulatory authorities.

What clinical trials has BIIB104 been in?

BIIB104 has completed several Phase 1 trials in healthy volunteers. These include NCT04068532, a study of pharmacodynamic effects on brain circuitry in the United Kingdom; NCT04079101 and NCT05148481, safety and pharmacokinetic studies in Japanese and non-Japanese participants; and NCT05152485, a relative bioavailability and food effect study.

Is BIIB104 the same as any other drug?

BIIB104 is the sole name provided for this investigational compound. No alternative names are listed for BIIB104 in the available information. It is a distinct small molecule being studied by Biogen for cognitive impairment associated with schizophrenia.