Civitas Therapeutics has secured new funding from The Michael J. Fox Foundation for Parkinson's Research, which will support clinical testing of its inhaled Parkinson's therapy through the proof of concept stage.
The Chelsea, Mass., start-up, spun out of Alkermes ($ALKS) in early 2011, plans to begin a Phase I clinical trial by the end of this year for CVT-301, its lead drug candidate and an inhaled formulation of levodopa (L-dopa). A Phase 2 proof of concept trial will launch and finish in 2012, the company has said.
Civitas CEO Glenn Batchelder declined to disclose the grant amount, though the company raised $20 million in Series A money to fuel its Parkinson's program. He told FierceDrugDelivery that Civitas' development focus dovetails with The Michael J. Fox Foundation's desire to find better drug-delivery options for L-dopa to treat Parkinson's symptoms. More than 1 million people in the U.S. suffer from the disease, a neurodegenerative disorder stemming from the body's reduced production of the neurotransmitter dopamine that leads to debilitating motor function and other symptoms.
"The Michael J. Fox Foundation has identified effective L-dopa delivery as one of the major unmet needs for symptomatic treatment of Parkinson's disease," Batchelder said in an e-mail interview.
CVT-301 uses an inhaled version of L-dopa incorporated into Civitas' ARCUS inhalation platform - a proprietary dry powder and inhaler designed for patient use, and inherited as part of the Alkermes spin-out.
Civitas believes the 40-year-old L-dopa drug will work better at maintaining peak L-dopa plasma concentration than the more common oral delivery, which is not absorbed right away and can lead to variable plasma levels, and debilitating Parkinson's symptoms. The company theorizes its inhaled version will be more effective by directly hitting the blood and then brain, bypassing the gastrointestinal system.
Batchelder says early pre-clinical animal testing has so far generated positive results as far as safety, dosing, rapid treatment onset and proof that the delivery model is effective.
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