Cerevel Therapeutics announced positive topline results from a pivotal phase 3 trial for its D1/D5 receptor, tavapadon, in Parkinson’s disease, as the company awaits the closing of its $8.7 billion buyout by AbbVie.
The TEMPO-3 trial, which evaluated tavapadon as an adjunctive therapy to levodopa (LD), met its primary endpoint: Patients treated with tavapadon adjunctive to LD experienced a clinically meaningful increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo. Dyskinesia — involuntary, erratic movements of the face, trunk or limbs — frequently occurs during long-term treatment with levodopa in patients with Parkinson's, impacting safety and quality of life
A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm.
Tavapadon, the first and only D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease, has a novel mechanism of action, selectively activating D1/D5 dopamine receptors. Despite its recent success, it was not the standout asset in AbbVie's $8.7 billion acquisition announced back in December. AbbVie, at the time, had highlighted emraclidine, Cerevel's positive allosteric modulator currently in phase 2 trials for schizophrenia
Despite receiving a FTC "second request" for additional information and documentary materials back in February, AbbVie says the deal is still slated to conclude by mid-2024.
