For decades, people with Parkinson’s disease have been taking L-dopa pills to keep symptoms of the neurodegenerative disease under control. But now the Michael J. Fox Foundation is betting that a new form of the drug can be inhaled into the lungs to provide fast relief when the old standby isn’t getting the job done.
The New York-based Michael J. Fox Foundation for Parkinson’s Research is announcing today it is providing an undisclosed grant award to help Chelsea, MA-based Civitas Therapeutics develop an inhaled form of levodopa (L-dopa) for Parkinson’s disease. Civitas plans to use the Fox Foundation support, along with its $20 million Series A investment from earlier this year, to run a pair of clinical trials over the next year that will seek to prove that an inhalable L-dopa can be a viable alternative to the pill form. The first clinical trial of the drug, CVT-301, is set to begin before year’s end, says Civitas CEO Glenn Batchelder.
Patients with Parkinson’s tend to take L-dopa pill about three times a day, to try to keep a steady amount of the drug in the bloodstream. Take too much, and it won’t do much good, and it can cause side effects. Too little means that the telltale symptoms like tremors and stiffness start to appear. Various companies have tried other ways to deliver steady doses of the drug, through skin patches or infusion-based medicines, with little to show for it. If Civitas, a spinoff from Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]), can create an inhalable form, it could end up providing a quick and steady dose for those instances when the pills don’t work. The demand for such a treatment could be big, since about 1 million people in the U.S. suffer from Parkinson’s.
“People have been trying to deliver L-dopa, the gold standard treatment, for 40 years,” says Batchelder. “We believe this is the technology that will really make a difference.” Todd Sherer, the CEO of the Michael J. Fox Foundation, added in a statement that L-dopa delivery challenges “represent a critical unmet need in Parkinson’s disease.”
Civitas has a lot more resources than the typical venture-backed startup might have to pursue this kind of challenge. The company is housed in a Chelsea, MA, facility that represents more than $100 million of investment, which Alkermes built up years ago to make inhalable insulin for diabetics through a partnership with Eli Lilly (NYSE: [[ticker:LLY]]). Lilly scrapped that program in 2008, which got people thinking about what other inhalable drugs could be made there. By January, the assets were spun out into a new company, Civitas Therapeutics, which secured $20 million in a financing co-led by Canaan Partners and Longitude Capital.
The key challenge that Civitas is facing is with what you could call drug transportation. The existing L-dopa pills are swallowed and make their way into the intestines, where they get absorbed into the bloodstream. Sometimes the amount of drug concentration that actually gets into the blood can be erratic, however, because L-dopa can get blocked in the digestive tract when there are large protein molecules from food that get in the way, Batchelder says.
“Orally, it goes in, and it may get into your blood in 30 or 60 or 90 minutes, or maybe not much will get in at all,” Batchelder says. “Through the lungs, you can get precise dose.”
Civitas will have to prove
