The European Medicines Agency (EMA) has eliminated the requirement for pediatric clinical trials of mesdopetam, Irlab Therapeutics' experimental therapy for levodopa-induced dyskinesia in Parkinson's disease patients. This regulatory decision streamlines the drug's development pathway and follows a similar waiver previously granted by the U.S. Food and Drug Administration (FDA).
The EMA's Pediatric Committee recommended the waiver, removing the obligation for Irlab to submit pediatric investigation plans before seeking marketing authorization in the European Union. Such waivers are typically granted when pediatric drug development is deemed inappropriate or unfeasible.
"We are pleased that EMA has confirmed that pediatric studies evaluating mesdopetam are not needed to support a market authorization application for Parkinson's disease," said Kristina Torfgård, PhD, CEO of Irlab Therapeutics.
Mechanism of Action and Treatment Context
Mesdopetam, previously known as IRL790, targets the D3 dopamine receptor, which has been implicated in levodopa-induced dyskinesia. This condition, characterized by uncontrolled involuntary movements, frequently develops in Parkinson's patients during long-term levodopa therapy. While levodopa remains the primary treatment for Parkinson's motor symptoms by addressing dopamine deficiency, its extended use often leads to complications including dyskinesia and "off periods" between doses.
Promising Phase 2b Results
Recent Phase 2b clinical trial (NCT04435431) results demonstrated the efficacy of mesdopetam at its higher dose of 7.5 mg, administered twice daily. Compared to placebo, the treatment:
- Reduced levodopa-induced dyskinesia
- Increased "good on time" (periods with well-controlled symptoms without dyskinesia)
- Decreased "off times" (periods of poor symptom control)
- Showed potential in reducing dyskinesia severity
Moving Forward: Phase 3 Plans
Irlab is now preparing for a Phase 3 clinical trial to evaluate mesdopetam's efficacy in adult Parkinson's patients experiencing at least two daily hours of dyskinesia. The study will maintain the successful Phase 2b dosing regimen of 7.5 mg twice daily over approximately three months.
Beyond its primary anti-dyskinetic effects, preclinical research has indicated mesdopetam's potential in addressing Parkinson's-related psychosis, a common non-motor symptom characterized by hallucinations and delusions.
"Since we have previously received a corresponding decision from the FDA, the decision from EMA means we can now focus our development efforts entirely on activities in more relevant patient groups," Torfgård explained, highlighting the company's streamlined path forward in adult patient populations.
