Unexpected but positive results from a late-stage clinical trial were announced by Cerevel Therapeutics and reported in BioPharma Dive last week much to the surprise of AbbVie, the company that is in the process of acquiring Cerevel.
The investigational drug being tested to treat Parkinson’s is called tavapadon. Comparing against a placebo, symptom control was extended by one hour.
About the Treatment
When dopamine and levodopa which are common Parkinson’s medications take effect, the patient will experience symptom control called “on” time meaning that the patient is functioning well and is able to move about.
The unexpected bonus in the Phase 3 study occurred due to the reduced length of “off” time experienced by study participants enabling them to meet one of the secondary goals of the trial.
Parkinson’s causes people to cycle between “on” and “off” periods as the effect of drugs like levodopa and carbidopa begins to fade. Tavapadon was administered over levodopa as adjunctive therapy.
According to one analyst in a statement to his clients, the therapy successful in a high-risk trial, and hit several endpoints within the trial.
Admittedly developing Parkinson’s drugs is difficult because the disease has dissimilar elements (heterogeneous). Parkinson’s is associated with a range of cognitive and motor symptoms.
Although drugmakers have enjoyed minor success working with certain carbidopa and levodopa formulations, following through with new approaches has not been successful.
Parkinson’s patients exhibit a lack of the neurotransmitter, dopamine, in the brain. Levodopa and similar drugs that have been developed as replacements to a neurotransmitter will only work properly for a short period. This puts doctors in the position of having to prescribe stronger doses of other drugs that may be accompanied by increased side effects.
The new drug, tavapadon, targets specific receptors. Over stimulation of dopamine receptors causes side effects. Cerevel believes that tavapadon’s selective activation of receptors brings a better balance to motor improvements caused by the signaling of dopamine.
About the Study
Five hundred adults between 40 and 80 years old enrolled in the study conducted by Cerevel. The participants received tavapadon or were administered a placebo along with their continuing levodopa treatment.
In a period of 27 weeks, the tavapadon cohort averaged a 1.7 hour increase in “on” time minus involuntary twitches (dyskinesias). This increase contrasts to the placebo cohort that reported an increase of 0.6 hours.
Side effects reportedly were moderate, and the drug appeared to be well tolerated.
Cerevel has only released summary results to date but announced that it plans to provide full data at future medical meetings. Two additional trials for tavapadon are ongoing. The results are expected in the second half of 2024.
