AbbVie once again reported positive Phase 3 data for a Parkinson’s disease drug that was acquired from its Cerevel buyout, this time as a monotherapy.
Topline data show that both doses of tavapadon achieved the primary endpoint in the TEMPO-1 study, improving on parts II and III of a Parkinson’s measurement scale called the MDS-UPDRS after 26 weeks. The improvements from baseline were statistically significant when compared to placebo, and both doses hit a p-value of p<0.0001, AbbVie said.
In the study, a 5 mg dose induced an average -9.7-point improvement and the 15 mg dose improved scores by an average -10.2 points. Patients in the placebo group saw an average 1.8-point increase in their scores.
Tavapadon is a selective dopamine D1/D5 receptor partial agonist originally developed by Pfizer, but whose development was terminated in 2017 before being spun out into Cerevel a year later. AbbVie’s acquisition of Cerevel closed last month.
Thursday’s data follow a win in the Phase 3 TEMPO-3 study in April in the adjunctive setting for adults with late-stage Parkinson’s who are already on levodopa, a common treatment for this group. The Phase 3 TEMPO-2 trial, testing tavapadon as a flexible-dose monotherapy, is expected to read out by the end of the year.
While AbbVie executives said a schizophrenia drug called emraclidine carried “the bulk of the value” of the acquisition, tavapadon is the most advanced program in the company’s pipeline. AbbVie isn’t sharing when it plans to file for an approval with the FDA, a company spokesperson said.