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Civitas' inhaled Parkinson's drug promises novel delivery with positive PhII results

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Civitas Therapeutics heralded a successful Phase II trial result for its inhaled Parkinson's drug CVT-301, the novel delivery of which promises to make the disease more manageable for patients on an everyday basis, the company says.

Using its ARCUS delivery platform, a method that incorporates a dry powder and a dose-controlled, self-administered inhaler, the new CVT-301 introduces the tried-and-true Parkinson's drug levodopa, or L-dopa, into the lungs, where it is rapidly picked up by the bloodstream and crosses the blood-brain barrier. Parkinson's affects a person's ability to produce dopamine, which allows for controlled motor function, and L-dopa breaks down in the brain as a replacement for the neurotransmitter. The problem with the standard-of-care oral administration of L-dopa, according to Civitas CEO Glenn Batchelder, has been with the inconsistency of timing and dosing through the digestive system.

Therefore the direct transport of the chemical into the brain is a clear choice, Batchelder told FierceDrugDelivery over the phone. He said CVT-301, as a supplement for oral administration, can be used at times when the patient can feel his or her symptoms returning--an "off" episode in the Parkinson's community--for quick and dependable recovery of motor function. With the ARCUS platform, too, the amount in each dose remains consistent regardless of the patient's breathing rate.

"Through the oral route, there's an enormous variability of the time it takes and how much of it gets to the brain," Batchelder said. "L-dopa is challenging for a number of reasons, but with the inhaled dose, we can have a very measured response. It's ideal as an adjunct therapy."

Phase IIa was a randomized, placebo-controlled design in the clinic, and Civitas will move forward into Phase IIb trials, Batchelder said, in which patients will monitor their use of the drug at home over a month's time.

Civitas is a spinout of Alkermes ($ALKS), which licensed the ARCUS technology from MIT professor Robert Langer's Advanced Inhalation Research startup. The Michael J. Fox Foundation has been supportive of Civitas' work, Batchelder said, as one of the organization's lead researchers called the results "great news for a great drug."

- here's the release
- and here's FierceBiotech's take
- and more from the Michael J. Fox Foundation

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