Fipamezole Hydrochloride

Ipsen is in a deal-making mood. On Thursday, the company put down $28 million upfront and another $335 million in biobucks for the rights to IRLAB’s mid-stage candidate for levodopa-induced dyskinesia (LID) — a condition related to Parkinson’s disease that tripped up the French biotech about a decade ago. “This is something that fits nicely with our strategy in neuroscience, with movement disorders, and we’re also obviously looking more broadly in other therapeutic areas, in our core therapeutic areas, including rare diseases and oncology,” executive VP and head of R&D Howard Mayer told Endpoints News. IRLAB’s mesdopetam is currently in a Phase IIb study in LID that’s set for a readout in 2022. Researchers believe the drug also has potential to treat psychosis in Parkinson’s disease, and Mayer says it could enter the clinic for that indication the same year. Parkinson’s disease is commonly treated with a drug developed back in the 1960s called levodopa, which works by replenishing the brain’s supply of dopamine. But by the early 70s, scientists began looking into whether the drug was causing dyskinesias, or impairments of voluntary movement. It’s estimated that 40% to 50% of patients who use levodopa for at least five years develop LID — a side effect that causes involuntary or erratic movements, or slow and extended muscle spasms, according to Ipsen. In severe cases, the condition can be incapacitating. “It’s very, very debilitating, affecting activities of daily living, and obviously complicates their Parkinsonian symptoms,” Mayer said. Mesdopetam works by blocking a dopamine receptor called D3, which has been genetically linked to an increased risk of involuntary movements. Parkinson’s patients with LIDs have been found to have higher amounts of D3 receptors in parts of the brain essential to the control of movement. In a Phase IIa study , patients who took mesdopetam with the standard of care saw a dose-dependent increase in daily time without dyskinesias, which IRLAB calls “Good ON” time, IRLAB said. At the best-performing dose, 7.5 mg, Good ON time increased by 5.6 hours daily in the treatment group, compared to one hour in the placebo group (p<0.002). Prior to treatment with mesdopetam, these patients only had about 6.3 hours of Good ON time per day, according to IRLAB. “When mesdopetam was given in addition to standard Parkinson medication, patients experienced considerably longer periods of good daily motor function without aggravated involuntary movements,” IRL CMO Joakim Tedroff said at the time. IRLAB will be responsible for the ongoing Phase IIb trial, while Ipsen is on the hook for all other clinical development and worldwide commercialization, including Phase III preparatory work. This isn’t Ipsen’s first shot at treating LIDs. Back in 2010, Ipsen gave Santhera Pharmaceuticals about $15.3 million upfront and promised another $151 million in biobucks for the rights to its LID candidate fipamezole outside North America and Japan. But a short two years later, the company returned the rights to Santhera, which later dropped it from the pipeline.