Lundbeck has agreed to acquire Prexton Therapeutics for up to €905 million ($1.1 billion), in a deal that adds a Phase II Parkinson’s disease candidate to the Lundbeck’s pipeline focused on neurological as well as psychiatric disorders. Prexton has drug candidate foliglurax in phase II testing for treatment of Parkinson’s disease, with first data expected to be available in the first half of 2019.
“By acquiring Prexton, Lundbeck will obtain global rights to foliglurax, an exciting first-in-class compound, and gain full control of the asset,” said Anders Götzsche, interim CEO and CFO at Lundbeck. “Foliglurax addresses high unmet needs with its potential indication in Parkinson’s fitting perfectly within Lundbeck’s core areas and this treatment option also appears to be highly interesting for patients, physicians and payors.”
Foliglurax works by stimulating a specific glutamatergic target (mGluR4) which activates a compensatory neuronal system in the brain which is largely unaffected in Parkinson’s disease. Animal models have convincingly demonstrated positive effects in models of Parkinson’s disease. The aim is to treat the motor symptoms of Parkinson’s disease, such as resting tremor, muscle rigidity and uncontrolled movements (dyskinesia).
Lundbeck will pay EUR 100 million upfront to the current investors of Prexton Therapeutics BV. Furthermore, Lundbeck is required to pay up to EUR 805 million in development, regulatory and sales milestones depending on successful outcome of certain undisclosed milestones. More than half of the EUR 805 million is connected to sales milestones.
Foliglurax (PTX002331) is a small-molecule positive allosteric modulator of group III metabotropic glutamate receptor 4 (mGluR4 PAM), for the potential oral treatment of Parkinson’s disease.
A single- and multiple-ascending oral dose phase I trial (NCT02639221) in healthy volunteers with foliglurax was successfully completed in 2016. The results showed that foliglurax appears well-tolerated with a satisfactory pharmacokinetic (how the drug is processed in the body) profile.
In July 2017, Prexton initiated a phase II clinical trial (NCT03162874) with foliglurax. The trial will enroll around 165 Parkinson’s patients in sites across six European countries (U.K., Germany, France, Austria, Spain, and Italy). The double-blinded, randomized, placebo-controlled, parallel-arm study will assess the effectiveness, safety, and tolerability of foliglurax in reducing motor complications of levodopa therapy in patients experiencing end-of-dose wearing-off and levodopa-induced dyskinesia.
Two groups will receive oral doses (10 mg and 30 mg) of the treatment over 28 days, in addition to their standard medication, incl. levodopa. A third group will receive placebo. The primary outcome measure will be the change in the daily awake “OFF“-time (i.e. time where the treatment does not work) based on patient diary entries between the start and end of treatment. The study is expected to be completed in 2019.