Date: 2013-12-17
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: to-BBB (The Netherlands)
Product: 2B3-201
Action mechanism:
Disease:
Therapeutic area: CNS diseases - Neurodegenerative diseases - Cancer - Oncology - Neuroinflammatory diseases
Country:
Trial details:
Latest
news: * On December 17, 2013, to-BBB has announced that the First-in-Human study with 2B3-201,was initiated at the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. This Phase I trial is designed to determine the safety profile, and will also give a first glance at the pharmacological profile. In this double-blind crossover study, 18 healthy volunteers are assigned to three cohorts in which they will receive an ascending single dose of 2B3-201, as well as placebo and standard of care methylprednisolone. 2B3-201 is being developed for treatment of diseases with neuroinflammation, such as acute relapses of multiple sclerosis (MS). The current standard of care methylprednisolone is effective, yet it requires high dose infusions for several days. This often results in side effects and inconvenience for the patient.
Following an extensive nonclinical development program, to-BBB initiated the Phase I clinical trial. The aim of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 2B3-201 in healthy volunteers, in comparison to placebo and methylprednisolone. Using a double-blind crossover design, each healthy volunteer receives an infusion of 2B3-201, placebo and methylprednisolone with 1-week intervals, thereby acting as his own control.
2B3-201 is expected to follow a relatively short route towards marketing authorization. In addition to acute MS relapses, there is significant therapeutic potential in related inflammatory diseases, such as optic neuritis, neuromyelitis optica (NMO), uveitis, Behçet’s disease, sarcoidosis, and neuropathic pain.
