Lundbeck Acquires Rights to Develop Foliglurax Therapy Candidate to Treat Parkinson’s

Lundbeck will acquire the biopharmaceutical Prexton Therapeutics, obtaining the development and commercialization rights to foliglurax (PTX002331), an investigational therapy currently in Phase 2 trials for Parkinson’s disease.

Foliglurax is a small molecule modulator that activates nerve cells with a set of specific glutamate receptors called mGluR4, and compensates for the lack of dopamine in the brain. Activating mGluR4 is expected to correct the impaired motor behaviors in Parkinson’s disease.

In preclinical studies with animal models of Parkinson’s disease, foliglurax showed positive effects in modulating the disease course. And in a Phase 1 clinical study (NCT02639221) with healthy volunteers, the treatment was found to be safe and well-tolerated.

In July 2017, Prexton launched a proof-of concept Phase 2 clinical trial (NCT03162874) called AMBLED to test foliglurax in Parkinson’s patients.

The AMBLED study, currently recruiting participants at 44 sites in six European countries, is a double-blind, randomized, placebo-controlled trial expecting to recruit 165 Parkinson’s patients who have previously been treated with a stable regimen of levodopa-containing therapy.

Patients will be randomized to one of two oral doses of foliglurax (10 mg or 30 mg), or a placebo, for 28 days.

The trial’s primary goal is to evaluate the effectiveness of the treatment candidate in reducing levodopa-induced motor complications, also known as levodopa-induced dyskinesia. This is a condition characterized by involuntary movements that usually occur after prolonged treatment with levodopa in Parkinson’s patients.

The study is expected to be completed in 2019.

“By acquiring Prexton, Lundbeck will obtain global rights to foliglurax, an exciting first-in-class compound, and gain full control of the asset,” Anders Götzsche, interim CEO and chief financial officer of Lundbeck, said in a press release.

“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,” he added.