Civitas Therapeutics Announces Positive Phase IIb Results for CVT-301, Inhaled Levodopa for the Treatment of Parkinson’s Disease

Civitas Therapeutics Inc., a privately-held pharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, has announced positive results from a Phase IIb clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa). Study results from Phase II studies were presented at the 66th Annual American Academy of Neurology Meeting on 29 April 2014 at in Philadelphia, PA. 

“We are extremely pleased that we met our primary endpoints in our Phase IIb trial with statistical significance, demonstrating that CVT-301 was safe and well tolerated and provides patients with a rapid, clinically important improvement in motor function. CVT-301 provided onset of action by 10 minutes with durable effects lasting for at least 60 minutes,” said Mark Iwicki, President and CEO of Civitas. “CVT-301 is being developed to address a significant unmet need facing Parkinson’s disease patients today, and these results, particularly the efficacy and ease-of-use seen in the outpatient setting, give us confidence that CVT-301 can have a transformative impact on the daily lives of patients.”   

CVT-301 is being developed as an adjunctive, as-needed therapy to provide rapid and reliable relief from intermittent debilitating motor fluctuations, known as OFF episodes, suffered by Parkinson’s disease patients. OFF episodes, which result from the unpredictable nature of oral baseline therapies, affect over half of all patients on an oral L-dopa treatment regimen and are considered to be one of the most important issues facing Parkinson’s disease patients today.   

“OFF episodes are debilitating events for Parkinson’s disease patients. A rapid and reliable therapy that can address these episodes would be a major advancement in treatment," said Dr Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson's Research, which provided supportive funding for the study. “These results suggest that CVT-301 could have a transformative impact on patients’ lives,” said Dr Sherer. “As supporters of this program from its early days, we are pleased with its performance thus far and look forward to continued success in Phase III trials.”  

The Phase IIb study was designed to assess the on-demand use of CVT-301 in Parkinson’s disease patients experiencing motor fluctuations over a one-month period. The trial evaluated the efficacy, safety and tolerability of two doses of CVT-301. Motor responses were evaluated during regularly-scheduled clinical visits using the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III). In addition, efficacy was also evaluated during out-patient use with commonly used diary-based outcomes measures. 

The primary endpoint was successfully met with CVT-301 achieving a clinically important and statistically significant reduction in average UPDRS III motor score versus placebo at time points ranging from 10 to 60 minutes post-administration (p < 0.001).  Furthermore, clinically important and statistically significant improvements in UPDRS III were seen at every time point including 10 minutes, the earliest time point tested, for both tested doses.