London, 2 November 2015 – Canbex Therapeutics Ltd today 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.
"The Canbex team is very pleased that VSN16R has reached this important milestone," said Dr Jesse Schulman, Canbex's CEO. "This brings us a step closer to potentially bringing patients a much needed new treatment for this debilitating and disabling condition," Schulman added.
Spasticity consists of involuntary spasms and stiffness of limbs and torso. It affects some 84% of the estimated two million people with multiple sclerosis worldwide, and is also common following spinal cord injury and stroke. Spasticity disrupts walking and other activities of daily life, is painful and damaging to joints, and in severe cases can be completely disabling. Current systemic treatments for spasticity are limited in their usefulness by sedation and other cognitive side effects.
In February 2015, Canbex entered into an option agreement with Ipsen, the Paris-based global specialty pharmaceutical group, 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 EUR90m in milestones related to the development and commercialisation of VSN16R in spasticity plus royalties.
VSN16R is the most advanced compound in Canbex's platform of non-sedating regulators of neuronal excitability. Under the option agreement with Ipsen, Canbex shareholders retain rights to additional VSN compounds for indications outside of spasticity.
Canbex is a spin-out of University College London (UCL) that was established to develop its proprietary VSN compound series. In addition to its pioneering scientific founders and clinical advisors, Canbex has assembled a skilled and focused management team. Development activities are carried out through leading CROs and CMOs. The company's capital efficiency and lean management strategy ensure that funds are deployed directly to compound development. Investors include the Wellcome Trust, MS Ventures, Fast Forward LLC, UCL Business Plc and Esperante.
For more information, visit www.canbex.co.uk.