On the same day that some Parkinson’s disease drugs are being called into question, AbbVie has announced that its late-stage monotherapy candidate has significantly reduced the burden of the disease in patients compared to placebo
The phase 3 TEMPO-1 trial tested two daily doses (5 mg and 15 mg) of tavapadon, an oral dopamine receptor agonist. Both arms beat placebo at improving disease burden at Week 26 as measured by a combined score using parts of an industry scale dubbed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, according to a Sept. 26 release.
In addition to the primary endpoint, tavapadon also hit a secondary endpoint, improving the mobility of patients in their daily lives, AbbVie said in the release.
Most side effects were mild to moderate in severity and consistent with past clinical trials, according to AbbVie.
Tavapadon partially binds to the D1 and D5 dopamine receptors, which play a role in regulating motor activity. It’s being developed both as a monotherapy and in combination with levodopa, a biological precursor to dopamine that is often used as a first-line treatment for Parkinson’s.
AbbVie plans to share results from another phase 3 trial of tavapadon later this year, the pharma said in the release. That trial is testing the drug as a flexible-dose monotherapy.
The pharma got its hands on tavapadon last year after buying out Cerevel Therapeutics for a whopping $8.7 billion. The other shining star of that deal is emraclidine, which is currently being tested in schizophrenia and Alzheimer’s disease psychosis. The muscarinic M4 selective positive allosteric modulator is in the same class as Karuna Therapeutics’ KarXT, which awaits an FDA approval decision that's slated for today.
The AbbVie data come amid claims that prasinezumab, a Parkinson’s drug being developed by Prothena Biosciences and Roche, was built on a foundation of shaky science, according to a Science investigation published today. More than 100 research papers by Eliezer Masliah, M.D., the longtime head of the National Institute on Aging's neuroscience division, were found to contain apparently manipulated images, including four papers that were foundational to the development of prasinezumab, according to Science.