APL-130277 is a formulation of apomorphine being developed by Sunovion for sublingual (under the tongue) administration. The treatment is designed to reduce the off episodes of Parkinson’s disease patients, particularly morning episodes that can be difficult to treat. Off episodes occur when symptoms reappear as a therapy wears off and before the next dose takes effect.
The U.S. Food and Drug Administration (FDA) approved an injectable apomorphine called Apokyn to decrease off episodes in patients with advanced Parkinson’s disease. However, Apokyn can cause pain and injection-site reactions.
Sunovion submitted a new drug application to the FDA in April 2018 for APL-130277. The FDA’s response in 2019 stated that the treatment could not be approved at the time and requested additional information. However, Sunovian is continuing to develop APL-130277.
How APL-130277 works
Parkinson’s disease is caused by a loss of nerve cells in the brain, which, in turn, causes a decrease in dopamine, an important signaling molecule. Many treatments for Parkinson’s disease aim to increase dopamine levels in the brain either by reducing dopamine clearance or increasing dopamine secretion.
However, in between medication doses, patients often experience off periods when their dopamine levels dip low, causing an increase in symptoms.
APL-130277 is a fast-acting, thin-strip film coated with apomorphine, a small molecule that binds to the dopamine receptor and activates it, mimicking the effect of dopamine in the brain.
APL-130277 in clinical trials
Sunovion conducted a Phase 2 clinical trial (NCT02228590) to assess APL-130277’s safety, effectiveness, and tolerability. A key finding from this trial was that its 19 patients were able to go from off to on states without the complications associated with injecting apomorphine.
A Phase 3 clinical trial (NCT02469090) recruited 219 Parkinson’s disease patients who were taking levodopa and experiencing at least one off episode — with a total off time of at least two hours — a day. Patients received either APL-130277 or a placebo, and were analyzed using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part 3 score — from pre-dose to 30 minutes after dosing at week 12. Preliminary results from 109 patients indicated a significant improvement in MDS-UPDRS scores in treated patients compared with those given the placebo. The treatment was also well-tolerated, with the most common side effects being nausea, sleepiness, and dizziness.
A second Phase 3 clinical trial (NCT02542696) is currently recruiting 226 patients with Parkinson’s disease in the U.S., Canada, and the U.K. to determine the long-term safety and effectiveness of APL-130277.
Some of the patients in the Phase 3 trials will also participate in a sub-study to determine whether computer technology can quickly measure disease progression and speed up the development of new treatments. Participants will use a wearable device and smartphone application to help researchers collect information about the effects of APL-130277, including its ability to improve patients’ movement. The Michael J. Fox Foundation and Intel Corporation developed the application.
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