Date: 2015-11-02
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Canbex Therapeutics (UK)
Product: VSN16R
Action
mechanism: undisclosed. VSN16R is a non-sedating regulator of neuronal excitability. In February 2015, Canbex entered into an option agreement with Ipsen, which aims to build a leading presence in the treatment of spasticity. If it exercises its option following Phase II, Ipsen will acquire 100% of the equity in Canbex and pay Canbex shareholders up to €90m in milestones related to the development and commercialisation of VSN16R in spasticity plus royalties.
Disease: spasticity caused by multiple sclerosis
Therapeutic area: Neurodegenerative diseases
Country: UK
Trial
details: This phase II proof of concept (PoC), double-blind, randomised, placebo-controlled study is evaluate the efficacy, safety, and pharmacokinetics of VSN16R for the treatment of spasticity in subjects with multiple sclerosis. (NCT02542787)
Latest
news: * On November 2, 2015, Canbex Therapeutics announced that its novel orally active medication for the treatment of spasticity, VSN16R, has entered a Phase II trial in patients with spasticity caused by multiple sclerosis. The randomized, double-blind, placebo-controlled multi-center trial is being carried out in the UK and aims to enrol 142 subjects. Canbex expects top line results to be available in 2016. In contrast to other systemic anti-spastics, VSN16R has been found to be non-sedating in all tests to date. VSN16R was safe and well tolerated in a 72-subject Phase I trial and was notable for its lack of cognitive or other side effects.