Convergence Pharmaceuticals has commenced phase II of a concept study of novel, small molecule, state-dependent calcium channel blocker CNV2197944 to treat pain related to diabetic peripheral neuropathy (DPN).
The randomised double-blind, placebo-controlled, two-period, two-treatment crossover study is designed to evaluate the efficacy and safety of a dose regime of CNV2197944 75mg three times a day against a placebo in patients with DPN.
The trial’s primary endpoint is to study the effect of repeat oral dosing of CNV2197944 on the pain experienced in DPN after three weeks, compared to the baseline, as measured by the Pain Intensity Numeric Rating Scale.
Convergence Pharmaceuticals chief executive officer Clive Dix said: "We have begun running a second proof of concept trial with CNV2197944 in neuropathic pain and are already excited about potential results."
Designed to selectively inhibit highly-active Cav2.2 channels, CNV2197944 has already completed safety and toxicology studies demonstrating its safety margin and tolerability.
"Based on the known pre-clinical and clinical profile of CNV2197944 and the data we have seen so far, we believe it will be a safer, more effective treatment for chronic pain, with a potentially better tolerability profile and wider therapeutic index than currently available treatments," Dix added.
Results from the study, which is being conducted by Convergence on behalf of Calchan, are expected to be presented in the second half of 2014.
Calchan is a part of Convergence Pharmaceuticals and holds the proprietary rights to CNV2197944.