H. Lundbeck has agreed to acquire Prexton Therapeutics for up to €905 million ($1.1 billion), the companies said today, in a deal that adds a Phase II Parkinson’s disease candidate to the buyer’s pipeline focused on neurological as well as psychiatric disorders.

Lundbeck has agreed to pay Prexton €100 million ($122.9 million) upfront, and up to €805 million ($989.1 million) in payments tied to achieving development and sales milestones.

“We are very excited to be working with Lundbeck, a company with a strong history and focus on diseases of the central nervous system,” Prexton founder and CEO François Conquet, Ph.D., said in a statement. “Lundbeck shares our vision for the development of foliglurax to help patients living with Parkinson’s disease.”

Dr. Conquet founded Prexton in 2012 with M Ventures, the corporate venture subsidiary of Merck KGaA formed to spin out companies focused on continuing activities and compounds that originated at Merck Serono following the shutdown of its Geneva-based operations—a category that includes foliglurax. M Ventures joined Forbion, Seroba Life Sciences, Sunstone Capital, and Ysios Capital as major investors in Prexton, with Forbion and Seroba last year leading a €29 million ($35.6 million) Series B financing round.

Lundbeck would inherit global rights to foliglurax (PTX002331), now in an ongoing mid-stage study for the symptomatic treatment of OFF-time reduction in Parkinson’s disease and dyskinesia, including levodopa-induced dyskinesia. The study (NCT03162874) compares two dosages of foliglurax (10 mg and 30 mg) to placebo. The primary endpoint is change from baseline to end of the treatment period in the daily awake OFF time based on subject Hauser diary entries.

The study is being conducted in six European nations—Austria, France, Germany, Italy, Spain, and the U.K. Recruitment has begun toward the study’s estimated enrollment of 165 participants, according to the latest update Monday on ClinicalTrials.gov. The First data from the Phase II program is expected to be released in mid 2019, Lundbeck and Prexton said today.

A second Phase II study assessing foliglurax has not yet begun recruitment of participants. In that study (NCT03331848), a 20-mg dose of foliglurax will be compared to placebo in an estimated 86 participants with Parkinson’s who were treated with a stable dose of levodopa and are experiencing motor complications of levodopa therapy. That study’s primary endpoint will be change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with Parkinson’s experiencing levodopa-induced dyskinesia.

Stimulating mGluR4

Foliglurax is an oral, small-molecule, positive allosteric modulator of group III metabotropic glutamate receptor 4 (mGluR4 PAM). Foliglurax is designed to treat the motor symptoms of Parkinson’s, such as resting tremor and dyskinesia, by stimulating mGluR4, which in turn activates a compensatory neuronal system in the brain. Prexton has cited preclinical studies that have shown positive effects for foliglurax in models of Parkinson’s disease.

Foliglurax would join a Lundbeck pipeline anchored by Rexulti® (brexpiprazole), an atypical antipsychotic for which Lundbeck and the drug’s discoverer, Otsuka, are pursuing additional indications: The companies announced plans in November 2017 to launch a third Phase III study in the first half of this year assessing Rexulti for agitation in patients with Alzheimer's disease. The first two Phase III studies in that indication (NCT01862640 and NCT01922258) showed that patients treated with the drug showed improvements in symptoms of agitation relative to placebo.

Another Phase II trial (NCT03033069) now enrolling an estimated 332 participants is assessing Rexulti in adults with posttraumatic stress disorder (PTSD), both alone and in combination with Zoloft® (sertraline).

Rexulti won FDA approval in 2015 and is marketed in the U.S. for schizophrenia and as an adjunctive therapy to antidepressants for major depressive disorder. Last year, Rexulti generated DKK 1.247 billion ($205.7 million) in revenue, up 51% from DKK 826 million ($136.3 million) in 2016.

Lundbeck’s pipeline also includes Lu AF35700, the subject of the Phase II Anew study (NCT03230864) that began recruiting the first of an estimated 285 participants in July. The study is assessing the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease or late-in-disease treatment-resistant schizophrenia.

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