As it waits for its acquisition by AbbVie to finalize, Cerevel reported a Phase 3 win for one of its programs in Parkinson’s disease.
Patients taking the biotech’s once-daily drug, called tavapadon, on top of the already approved Parkinson’s treatment levodopa saw a statistically significant increase of 1.1 more hours of “on” time compared to placebo, according to an early Thursday press release.
Those taking the combo had 1.7 hours of “on” time without troublesome dyskinesia, while placebo patients had only 0.6 hours of “on” time. The 1.1-hour difference resulted in a p-value of p<0.0001. Dyskinesia is the scientific vernacular for the hallmark involuntary movements associated with Parkinson’s.
The win will give AbbVie a formidable chance at launching a new Parkinson’s drug after the deal closes, depending on the results of two additional monotherapy trials expected to be read out later this year. Last December, AbbVie announced it would acquire Cerevel — a Pfizer spinout — for $8.7 billion, and the deal is expected to close in the “middle of 2024.”
While a different drug — the schizophrenia candidate emraclidine — carried “the bulk of the value” of that acquisition, tavapadon represents the most advanced program in Cerevel’s pipeline and what AbbVie execs called “complementary” to its own Parkinson’s work. Leerink Partners analysts previously pegged 2023 sales at $300 million.
Tavapadon is a selective dopamine D1/D5 receptor partial agonist, which Cerevel believes can better modulate dopamine signaling in Parkinson’s patients without overstimulating other receptors. The drug was originally developed by Pfizer, which in 2017 terminated a Phase 2 trial due to “insufficient efficacy” before spinning out its whole neuroscience portfolio to Cerevel the year after.
Thursday’s results come from Cerevel’s TEMPO-3 trial, which is examining tavapadon in the adjunctive setting for adults with late-stage Parkinson’s who are already on levodopa, a common treatment for this group.
Cerevel said a key secondary endpoint was also reached, with a statistically significant reduction in “off” time, though no specifics were provided. Information about other secondary endpoints, including the MDS-UPDRS, was not disclosed.
In addition to two monotherapy trials targeting early-stage Parkinson’s patients, known as TEMPO-1 and TEMPO-2, Cerevel is also running an open-label extension study called TEMPO-4.
Readouts from the TEMPO trials had been delayed multiple times due to Covid-related disruptions. The latest plan, as communicated by Cerevel execs in a November investor call before the AbbVie buyout, was to file for an NDA in 2025 with data from all four trials.
“We’re thinking of it as really backbone therapy, meaning that when the patient is first diagnosed, as being the best therapy to initiate patients on, and then when levodopa needs to be introduced, as the best adjunctive treatment,” chief medical officer Raymond Sanchez said at the time.