Dosing has begun in Apello Pharmaceuticals’ Phase I dose-escalation study, examining the effects of their drug candidate, AP-472, on Parkinson’s. The drug was originally developed at Vanderbilt University and was funded by the National Institutes of Health and the Michael J. Fox foundation.
Parkinson’s impacts around 1 million Americans, and is characterized by resting tremors, slowness of movement, rigidness and other non-motor symptoms including those related to cognition. The disease occurs when nerve cells of the brain die off in the area of the neurotransmitters responsible for producing dopamine.
Current treatment options therefore often focus on dopamine replacement therapy, such as the widely prescribed levodopa. Treatments like these do relieve the primary symptoms of Parkinson’s effectively, but extended use often results in debilitating side effects such as dyskinesias (uncontrollable involuntary muscle movements.)
The treatment is a very selective modulator of one of the glutamate receptors that contributes to Parkinson’s disease progression and symptoms.
The Phase I study will involve a randomized, double-blind, placebo controlled study design. At this stage, the drug is not being tested on people with Parkinson’s, but rather on healthy adults of a wide age-range in order to assess the safety and tolerability, as well as the pharmacokinetics of the drug.
Should the treatment prove safe and tolerable, this stage of the trial will inform dose selection for future phases. In Phase IB and Phase II, clinical studies will begin in those with Parkinson’s.
In pre-clinical models, AP-472 activated glutamate receptor cells and reached the brain regions in charge of movement and relieved symptoms such as immobility and rigidity. This is because the treatment mitigates the steadily decreasing dopamine levels as a result of the disease progression, a process that without intervention dysregulates the brain’s glutamate signaling involved in movement.
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