Earlier today, Convergence announced the commencement of its Phase II proof of concept study using CNV1014802 for treating pain linked with lumbosacral radiculopathy (LSR).Convergence Pharmaceuticals Limited (“Convergence”) is a company focused on the development of novel and high value analgesics.
LSR causes stiffness of the nerve roots in the lumbar region of the spine and is a common neuropathic pain condition. Pain radiating from the lower back down the legs, sensory and motor impairment in the lower limbs are some of the common features associated with LSR. LSR is a very high unmet medical need, affecting 3-5% of the global population and there are no drug treatments currently approved for treating this type of neuropathic pain.
For patients with pain associated with LSR, the Phase II, randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy orally administered CNV1014802. The innovative study including a number of design features will augment confidence in the outcome of the study. The trial that will be conducted in four European countries will release its results in the second half of 2012.
“We are delighted to announce the start of this trial; the second clinical stage trial initiated since our conception as a Company in October 2011 and a testament to our innovative team. It is clear that safe, effective pain treatment is urgently required and we are focused on driving forward the development of our pipeline to meet this need,” says Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals.
Simon Tate, Chief Scientific Officer of Convergence Pharmaceuticals commented on the announcement saying, “We are very excited to be initiating this Phase II study for CNV1014802. CNV1014802’s differentiated and superior profile could have a significant impact on the treatment of patients with pain associated with lumbosacral radiculopathy (LSR), who currently have no approved treatment available to them. CNV1014802 offers the potential of a safe, effective treatment for this common neuropathic pain.”
The novel small molecule, CNV1014802, is a state-dependent sodium channel blocker that exhibits potency against the Nav1.7 sodium channel. It was recently validated as a key pain target by human genetic linkage. The latest and exciting study data generated by Convergence scientists established that CNV1014802 exhibited a highly state-dependent blockage of sodium channels that convey painful sensations, and is therefore found to have a superior and differentiated profile of activity at Nav1.7. In experimental paradigms, this profile translates into significant block of Nav1.7 channels. This is similar to the higher frequency and spontaneous neuronal firing as seen in entrapment neuropathies such as LSR.
Extensive Phase I studies using CNV1014802 have been completed in over 150 healthy volunteers with single and repeated doses thus signifying an exceptional pharmacokinetic and safety profile. CNV1014802 exhibited a perfect pharmacokinetic profile along with an outstanding tolerance at doses within the expected therapeutic range.