BIIB-100 is under clinical development by Biogen and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect BIIB-100’s likelihood of approval (LoA) and phase transition for Amyotrophic Lateral Sclerosis took place on 29 Jun 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their BIIB-100 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

BIIB-100 overview

BIIB-100 (KPT-350) is under development for the treatment of traumatic brain injury, amyotrophic lateral sclerosis, autoimmune-inflammatory diseases such as multiple sclerosis, rheumatoid arthritis, Duchenne muscular dystrophy and systemic lupus erythematosus. It is administered by the oral route. The drug candidate acts by targeting Exportin-1 (XPO1, also called CRM1).

Biogen overview

Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, CNS and neuromuscular disorders, Alzheimer’s disease, and idiopathic pulmonary fibrosis and stroke. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.

Quick View BIIB-100 LOA Data

Report Segments
  • Innovator
Drug Name
  • BIIB-100
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Immunology
Key Developers
  • Sponsor Company: Biogen
  • Originator: Rega Institute for Medical Research and Karyopharm Therapeutics
Highest Development Stage
  • Phase I

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.