US-based biopharmaceutical firm Civitas Therapeutics has commenced Phase IIb clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa), being developed for the treatment of intermittent debilitating motor fluctuations (OFF episodes) associated with Parkinson's disease (PD).
The Phase IIb study (CVT-301-003) is a randomised, double blind, placebo controlled, parallel group trial currently being carried out in the US and Europe.
As part of the Phase IIb study, CVT-301 will be used in patients for one month continuously to see the efficacy and safety in treating emergent OFF episodes.
Additionally, efficacy of the study will also be evaluated during outpatient use with diary-based outcomes measures.
In the Phase IIa study for CVT-301, patients treated with CVT-301 in the OFF state produced a rapid and durable improvement in motor function.
According to the company, the pharmacokinetic data recapitulated the Phase I study results of CVT-301, which offered immediate L-dopa absorption and consistent increases in plasma concentrations in marked contrast to the delayed and variable L-dopa levels seen with Sinemet (oral L-dopa/carbidopa).
The company claims that in the Phase I, all doses of CVT-301 were safe and well-tolerated and there was no rise in the frequency or severity of dyskinesias relative to oral.
Civitas chief medical officer Martin Freed said in the next stage of development, patients will self-administer CVT-301 upon the emergence of their OFF symptoms as they go about their normal daily activities, exactly aligned with the intended treatment paradigm.
"The ease of use of the simple ARCUS inhaler allows patients to use CVT-301 wherever and whenever their oral Parkinson's medications begin to fail them in between their regularly scheduled doses," Freed said.
Part of the funding for the Phase IIb study of CVT-301 is being provided by a grant from The Michael J Fox Foundation for Parkinson's Research.
Preliminary data from the study, which will be carried out on 80 patients, will be released in the first half of 2014.
CVT-301 is being developed as an addition to the physical rehabilitation network (PRN) therapy that will provide rapid and reliable relief from OFF episodes that affect many patients with PD.
Caption: Structure of the PARK2 protein. Photo: courtesy of Emw.