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Civitas announces positive results from Phase II inhaled levodopa trial

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Civitas Therapeutics announced that its inhaled formulation of levodopa (L-dopa) for the treatment of "off episodes" associated with Parkinson's disease met its primary clinical endpoint in a Phase II trial.

The therapy CVT-301 improved average Unified Parkinson's Disease Rating Scale Part III scores compared to placebo at time points ranging from 10 to 60 minutes following delivery, Civitas said in a statement. During the first two weeks of the 86-patient trial, the participants received 35 mg of inhaled levodopa or placebo; during the final weeks they received 50 mg or placebo.

The inhaled medication is meant to be taken on an as-needed or "rescue" basis as a supplement to standard oral L-dopa therapy. Civitas says the standard regimen is unreliable and doesn't always prevent off episodes, which render a patient immobile and cause debilitating motor fluctuations.

"The reliability of oral L-dopa formulations is significantly compromised by delayed and unpredictable absorption and excessive variability in drug concentrations in the bloodstream inherent to the oral delivery route," the statement says.

Civitas says that its Arcustm technology, consisting of a proprietary dry powder and inhaler, delivers a precise dose to the lung for predictable L-dopa absorption.

Civitas CEO Mark Iwicki

"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," Civitas CEO Mark Iwicki said in a statement.

The company declined to be interviewed for additional information.

In the race to provide Parkinson's patients supplements to oral L-dopa, the common thread seems to be reformulations of proven compounds for new delivery methods.

This week Cynapsus announced positive early-stage clinical trial results for its reformulated, sublingually delivered apomorphine medication. The company's rescue therapy for the treatment of off episodes is meant to replace injected formulations of apomorphine. The results are detailed in a related FierceDrugDelivery story.

In addition, Israel's NeuroDerm is developing a patch to deliver L-dopa subcutaneously. The product is in Phase II.

More than 7 million people worldwide suffer from Parkinson's, including more than 1 million Americans, Civitas says.  

- read the release
- information about the trial on ClinicalTrials.gov

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