The first-in-man study of VSN16R will enrol a total of 72 healthy volunteers in a placebo-controlled, single ascending dose and multiple ascending dose design. The study is being carried out by Quintiles, the world’s leading clinical research organisation.
Spasticity is characterized by sudden and uncontrollable movements of limb and torso musculature, and is among the most painful, damaging and debilitating symptoms of multiple sclerosis. Current drug treatments have a high level of undesirable side effects, particularly sedation and cognitive dysfunction. Many patients cannot tolerate current treatments, and so are treated with palliative measures alone, or with drug regimes that result in poor quality of life.
“We are pleased to have advanced VSN16R to first dose in man, a significant milestone in the development of this novel product candidate,” stated the Chief Executive Officer of Canbex, Dr Jesse Schulman. “After years of highly promising preclinical research, we believe that VSN16R has the potential to become an important advance in the treatment of spasticity, a condition for which there remains a substantial unmet medical need.”
Initiation of the Phase I trial follows successful preclinical studies that have demonstrated the excellent safety, efficacy and tolerability of VSN16R.
Dr Keith Powell, Chairman of Canbex, said: “Our work with leading clinicians has pointed to the pressing need for a new agent that treats spasticity in multiple sclerosis without the debilitating side effects of the current best treatments.”
Canbex closed a £2.1m ($3.2m) funding round in April 2013, led by MS Ventures, the corporate venture capital arm of Merck KGaA, Darmstadt, Germany, and won a grant of £1.25 ($1.8m) from the UK government’s Technology Strategy Board in March 2013. Other investors in Canbex include the Wellcome Trust, the US National Multiple Sclerosis Society, University College London (UCL Business Ltd) and Esperante Ventures.