APL-130277 is a treatment that Sunovion is developing to reduce the time between a standard Parkinson’s therapy wearing off and the next dose of the therapy kicking in.
It consists of a fast-acting thin-strip film coated with apomorphine, a small molecule dopamine receptor agonist.
Parkinson’s off episodes occur when symptoms pop up again as the punch of a standard therapy wears off. APL-130277 is aimed at diminishing off episodes, particularly the morning versions that are the most difficult to treat.
The U.S. Food and Drug Administration has approved an injectable apomorphine called Apokyn to decrease off episodes in patients with advanced Parkinson’s disease. But its use is limited because it causes pain and injection-site reactions.
APL-130277 can overcome these limitations because it is administered by placing it under the tongue. And it works as rapidly as an injection.
How APL-130277 works
APL-130277 is a two-layer film. Sunovion crafted it to maximize apomorphine delivery without it disintegrating quickly.
The first layer is apomorphine. Sunovion designed it to ensure that the treatment is delivered within minutes and remains in the blood for a considerable time.
The second layer is a buffer. The company designed it so cells can absorb it easily and so it can neutralize the acid that is generated when it is absorbed.
APL-130277 in clinical trials
Sunovion conducted a Phase 2 clinical trial (NCT02228590) to assess APL-130277’s safety, effectiveness, and patients’ ability to tolerate it. A key finding was that the 19 patients were able to go from off to on states without the complications associated with under-the-skin administration of apomorphine.
The CTH-300 study involved 219 patients who were experiencing at least one off episode a day when receiving levodopa — and a total off time of at least two hours a day. APL-130277 improved the movement of 109 patients experiencing off episodes, the results showed. Patients also tolerated it well.
The CTH-301 trial will look at the therapy’s long-term safety and effectiveness in 226 people with advanced Parkinson’s. Sunovion is recruiting participants for it in the U.S., Canada, and the U.K.
Some of the patients in the Phase 3 trials will participate in a sub-study whose goal is to see if computer technology can help doctors get a quicker grasp on the progression of Parkinson’s and speed up the development of treatments for it.
Participants will use a wearable device and smartphone application to help researchers collect information on APL-130277’s effects, including its ability to improve patients’ movement. The Michael J. Fox Foundation and Intel Corporation developed the app.
Sunovion will use the trial results to support a New Drug Application for APL-130277 that it will file with the U.S. Food and Drug Administration by the spring of 2018. In August 2016, the FDA granted APL-130277 fast track designation as a treatment for Parkinson’s off episodes.
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