Civitas starts Phase 2a trial of Parkinson’s treatment

Glenn Batchelder, CEO, Civitas Therapeutics

Civitas Therapeutics, Inc., an inhaled therapeutics company in Chelsea, has announced that it began a Phase 2a clinical trial of its lead product, an inhaled form of an existing medicine used to treat the symptoms of Parkinsons disease.

The drug candidate, CVT-301, combines the drug levodopa (or L-dopa) with Civitas Arcus dry powder pulmonary delivery product. The company intends the combination to give immediate relief for motor fluctuations, or so-called off-episodes - the emergence of symptoms like muscle stiffness and slow movements despite taking medication.

The company announced preliminary results of Phase 1 trials in January, which indicated that the drug was being immediately absorbed in patients, and was safe and well-tolerated.

The Phase 2a study is being funded in part by a grant from The Michael J. Fox Foundation for Parkinsons Research. Twenty-four patients will be enrolled in a randomized, placebo-controlled, single dose, cross-over study that will look at the safety and tolerability of CVT-301. The study is designed to establish the dose for future clinical trials with CVT-301.

We demonstrated pharmacokinetic proof-of-concept for CVT-301 in less than 12 months from launching Civitas and are now initiating this Phase 2a study in Parkinsons patients, said Martin Freed, chief medical officer and co-founder of Civitas in a statement. Leveraging the ARCUS platform along with the 40 years of existing L-dopa clinical experience we hope to provide Parkinsons patients with a new therapy enabling improved management of their motor fluctuations.

More than 1 million people in the US suffer from Parkinsons disease, a neurodegenerative disorder caused by the diminished production of dopamine, which results in progressive impairment of motor function including tremors, rigidity and difficulty in moving, according to the company. Even when treated with the current standard of care, most of Parkinsons patients continue to experience motor fluctuations.

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Civitas starts Phase 2a trial of Parkinson’s treatment