Ipsen has entered into an exclusive worldwide licensing agreement with Integrative Research Laboratories (IRLAB) to develop and commercialize mesdopetam, an experimental therapy for reducing levodopa-induced dyskinesia, or involuntary movements, in people with Parkinson’s disease.
“We are excited to enter this licensing agreement with IRLAB. By working in partnership, we aim to bring investigational mesdopetam to people living with Parkinson’s disease experiencing levodopa-induced dyskinesia,” Howard Mayer, MD, executive vice-president and head of research and development at Ipsen, said in a press release.
“We are delighted to strengthen our pipeline and deepen our commitment to the neuroscience community around the world, including to patients living
with this debilitating neurodegenerative disorder,” he said.
Parkinson’s disease is characterized by the loss of dopaminergic nerve cells (neurons), which are responsible for the release of dopamine, a neurotransmitter (chemical messenger) essential for muscle control. Levodopa is a precursor to dopamine and long has been one of the gold standards for Parkinson’s treatment.
However, with disease progression patients often need to increase their levodopa dosage, which can lead to levodopa-induced dyskinesia.
Mesdopetam, given orally, works by blocking specific dopamine receptors called D3 receptors, which are linked genetically to an increased risk of involuntary movement. Parkinson’s patients with levodopa-induced dyskinesia have higher amounts of D3 receptors in parts of the brain that are essential for controlling movements.
By blocking only D3 receptors, levodopa-induced dyskinesia can be minimized while other beneficial effects of dopamine treatment can be maintained through its action on other receptors.
In previous clinical trials — one a Phase 1b (NCT03531060) and the other a Phase 2a (NCT03368170) — mesdopetam, when given as a capsule twice daily in addition to standard Parkinson’s medication, led to significantly longer periods of daily “on time” when compared to placebo. “On time” is when dopaminergic treatment is working and dyskinesia is not experienced.
The investigational therapy now is being evaluated in a Phase 2b study (NCT04435431), underway in Europe and the U.S. It is still recruiting participants; more information is available here.
Adults, ages 30 to 79 with Parkinson’s disease and at least two daily hours of levodopa-induced dyskinesia, are eligible to enroll. About 140 patients will be assigned randomly to receive one of three doses of mesdopetam or a placebo twice daily for 84 days.
The main goal is to assess the efficacy and safety of mesdopetam. Efficacy will be evaluated using patient diaries and measured by the amount of good “on time.”
Under the terms of the agreement, IRLAB will maintain responsibility for the ongoing Phase 2b study, while Ipsen will take the lead for Phase 3 studies and all remaining clinical development and worldwide commercialization.
IRLAB will be eligible to receive $363 million, including an upfront payment of $28 million and additional payments of up to $335 million upon the achievement of certain developmental, regulatory, and commercial milestones. IRLAB also is eligible to receive “tiered, low double-digit royalties” from worldwide sales, according to the press release.
“We believe in the potential of investigational mesdopetam for people with Parkinson’s disease experiencing dyskinesia or psychosis. We have purposefully worked to find a partner to pursue the late-stage clinical development of mesdopetam to commercialization and launch on a global market,” said Nicholas Waters, PhD, CEO of IRLAB.
“Ipsen shares the broad vision for mesdopetam and the commitment to people with neurological disorders. We are very excited to enter the final steps of the journey to market in collaboration with Ipsen. Additionally, we are proud of the accomplishment this important collaboration represents. The agreement and partnership with Ipsen is a validation of our proprietary discovery platform, ISP, and our drug development efforts,” he added.
Early studies are underway to assess the potential of mesdopetam as a treatment for Parkinson’s disease-related psychosis, a debilitating disorder that can occur in up to half of all Parkinson’s patients. In preclinical studies, mesdopetam was shown to have antipsychotic properties, according to Ipsen.
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