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Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study

Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial.

The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at bay, extending the total time of symptom control by just over one hour, compared to a placebo. This difference in “on” time was statistically significant, Cerevel said.

Tavapadon also significantly reduced the amount of “off” time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy, meaning it was added on top of levadopa.

The study’s success is a “major surprise,” according to Evercore ISI analyst Umer Raffat. “Not only has Cerevel hit in the highest risk trial they were conducting, they have also hit multiple endpoints within this trial,” Raffat wrote in a Thursday note to clients.

Parkinson’s drug development is difficult, as the disease is heterogeneous and leads to a wide range of motor and cognitive symptoms. Drugs like levadopa, which are designed to replace a neurotransmitter that’s depleted in people with the disease, can work well for a time. But their effectiveness gradually ebbs, forcing doctors to prescribe higher doses that come with increasing side effects.

Drugmakers have had some success with different formulations of levadopa and carbidopa, which works by promoting the neurotransmitter dopamine. They’ve run into challenges developing new treatment approaches, however. Just this week, Sage Therapeutics revealed a drug targeting a brain receptor called NMDA failed to improve cognition in Parkinson’s patients.

Tavapadon is aimed at the receptors dopamine hits, but only certain ones. Cerevel claims this selective activation could better balance the motor improvements brought on by dopamine signaling with the side effects that overstimulating dopamine receptors is thought to cause.

Over 500 adults between 40 years and 80 years old were enrolled in Cerevel’s study, and were randomized to receive either tavapadon or a placebo in addition to their existing levadopa treatment. Over 27 weeks, participants in the tavapadon group reported an average 1.7 hour increase in their total “on” time without involuntary movement twitches called dyskinesias. Those in the placebo group reported a 0.6 hour increase.

Most side effects were mild or moderate in severity and tavapadon was well tolerated, Cerevel said.

The company only released summary results Thursday, and plans to present full data at medical meetings in the future. Two other trials testing tavapadon on its own are ongoing, with results expected in the second half of this year.

By that time, Cerevel could be owned by AbbVie, which last fall agreed to pay $8.7 billion to acquire the biotech. The main draw wasn’t tavapadon, however, but an experimental schizophrenia treatment known as emraclidine.

Emraclidine doesn’t work like other schizophrenia drugs, and Wall Street analysts predict a multibillion-dollar market for it and a rival therapy from Karuna Therapeutics that’s similarly designed.

Analysts are mixed on how big of an opportunity tavapadon might represent. To Mizuho Securities’ Graig Suvannavejh, the Parkinson’s therapy is likely to only be a “small revenue contributor.” But Michael Yee, an analyst at Jefferies, sees potential for it to become a blockbuster, as its efficacy appears to compare favorably to recently approved Parkinson’s drugs from Amneal Pharmaceuticals and Kyowa Kirin.

For AbbVie, the drug could help round out a portfolio of Parkinson’s medicines that includes the drug Duodopa. The pharmaceutical company also recently acquired a small biotech called Mitokinin that’s working on a different kind of Parkinson’s therapy.