Biopharmaceutical firm Zalicus has started a Phase Ib clinical trial of Z944, a novel oral T-type calcium channel blocker, for the treatment of neuropathic pain.
The company expects to release the results from the laser-evoked potentials (LEP) study in the fourth quarter of 2013.
The study is designed to offer both objective and subjective data on a drug’s ability to modulate pain signalling.
In addition to subject-reported pain scores, vertex-Electroencephalography (EEG) is used to quantify electrical voltage fluctuations induced by laser thermal stimulation in this LEP clinical model study.
The LEP model has been used as an effective tool in benchmarking the efficacy of Z944 against other therapies in several pain drug studies.
Zalicus MD, president and CEO Mark Corrigan said measuring LEP is an experimental clinical model that provides both subjective and objective measures to assess the potential of Z944 to modulate pain signalling.
"T-type calcium channels are known to be widely implicated in the frequency and intensity of pain signals and the results of this study will further inform Zalicus’sdevelopment plans for Z944 in a variety of potential indications as we work to optimise a modified release formulation of Z944 for future clinical trials," Corrigan said.
The T-type calcium channels have been recognised as major targets for therapeutic intervention in a range of cell functions and have been implicated in pain signalling.
And Z944, a state-dependent, selective T-type calcium channel blocker, has showed preclinical efficacy in multiple inflammatory pain models
The company has already completed Phase I single and multiple ascending dose clinical studies evaluating the safety and tolerability of Z944.