Civitas was spun out of Alkermes (NASDAQ: ALKS) two years ago based on technology that can deliver a precise, high dose of a drug through an inhaler. With a new round of cash from the Michael J. Fox Foundation and some promising data from a small clinical trial in hand, the startup based in Chelsea, MA, is closer to proving that technology can help improve a decades-old, yet flawed, drug for Parkinson’s Disease.
Civitas is announcing today that it has won a $1 million grant from the Michael J. Fox Foundation to support second mid-stage study for CVT-301, an inhalable version of levodopa, or L-dopa pills, that is administered via a device “about the size of a large felt-tipped pen,” according to CEO Glenn Batchelder.
The grant is the second Civitas has received from the foundation, adding to a previous grant of just over $300,000 awarded in November 2011, Batchelder says.
While the grant will help Civitas support the study, the CEO says it will still need more cash to run it, and Civitas plans to raise a Series B round to help. Civitas raised $25 million in 2011 from Canaan Partners, Longitude Capital, and Foundation Healthcare Partners.
Civitas is developing CVT-301 as an adjunct therapy to L-dopa pills, so patients can take a puff and gain quick relief from what’s known as “off episodes,” when their medications stop working and symptoms—such as tremors and stiffness—start to reappear.
This would be a lucrative niche for Civitas to grab if it is successful. A majority of Parkinson’s patients—more than 70 percent, according to Batchelder—take L-dopa pills to manage their symptoms. But the drug’s concentration levels in the bloodstream are erratic because large protein molecules from food can block L-dopa before it is absorbed in the intestines. Several other companies have tried, and failed, to deliver L-dopa to patients in other ways—skin patches, for example—without much success.
Still, the potential market is attractive. Roughly one million Americans and six million people worldwide are living with Parkinson’s, according to the Michael J. Fox Foundation.
Civitas believes it has the answer with its spray. By delivering the drug through an inhalable device, the idea is that CVT-301 will act faster than the pill form of L-dopa because it doesn’t work its way through the gut.
Civitas isn’t trying to replace cheap, generic L-dopa pills. Rather, it wants patients to use CVT-301 as a supplemental security blanket. When patients feel an episode coming on despite taking their pills, they’d use the spray, as needed, to rapidly quell the symptoms until their next scheduled dose of oral medication.
“It’s for those moments where their meds fail them,” Batchelder says.
Civitas has a long way to go to earn that position in a chronic regimen, but the results so far have at least given it a shot. Civitas already has run a 24-patient mid-stage clinical trial, which it used to figure out the right dose of the drug, if CVT-301 is safe to use in Parkinson’s patients, how long the drug lasts, and to measure its effect on motor function. In that study, patients would take their morning medications, come into a testing site, and then randomly get either an inhalable placebo, a low (25 milligram) or high (50 milligram) dose of CVT-301, after one of their off episodes occurred. Investigators then monitored their safety, the plasma levels of L-dopa in their system, and their motor function over the next 180 minutes, according to Batchelder.
Civitas hasn’t revealed all the results of the study as of yet—it vaguely said in a statement today that it will unveil them at a “future scientific meeting”—but apparently they were good enough to move forward. Civitas said the data were positive, all the doses tested were generally safe and well tolerated, and that it has picked its dose level for the Phase 2b clinical trial.
Batchelder says that during the next study, patients will take CVT-301 home with them—or a placebo inhaler—and use it, as needed, during their off episodes. They’ll also be monitored in the clinic, like in the earlier mid-stage study, he says.
Civitas’ plan going forward, according to Batchelder, is to secure the Series B round to take it through the next clinical trial. At that point, the company would have the foundation to make a strategic move: potentially filing for an IPO or otherwise. Optimally, Civitas hopes to sign a partnership after the trial to get help selling the drug overseas while keeping its U.S. rights. Its ultimate goal is to show that the drug delivery technology can be applied to a number of other therapies.
“We see CVT-301 as the first of many products to follow,” Batchelder says.