Mesdopetam (IRL790)

Mesdopetam (IRL790) is a dopamine D3-receptor antagonist being developed for the treatment of levodopa-induced dyskinesias (LIDs), a severe form of troublesome involuntary movements commonly occurring in Parkinson’s disease. Mesdopetam also has potential in treating Parkinson’s disease Psychosis (PD-P).

Mesdopetam has a wide clinical potential for unmet medical needs in neurology. Firstly, the drug candidate is intended to treat people with Parkinson’s who develop LIDs, which is more than 30 percent of all people living with Parkinson’s. In the eight major markets worldwide, this equates to one million affected individuals.

Mesdopetam also has potential in treating Parkinson’s disease Psychosis (PD-P), which affects about 1.5 million people with Parkinson’s across the eight major markets worldwide.

Following a successful Phase Ib study, a completed Phase IIa study with 75 patients demonstrated compelling proof-of-concept with potential for superior efficacy, improving daily hours of ON-time without troublesome dyskinesias, versus current treatment options.

A Phase IIb study with 125 patients was completed with top-line results reported in January 2023. Mesdopetam demonstrated significant anti-dyskinetic effects as measured by UDysRS, a comprehensive scale measuring ON-phase dyskinesia with objective physician ratings and patient ratings. Additionally, mesdopetam displayed an adverse event and tolerability profile similar to placebo.

About the recommended INN, mesdopetam

Since early 2020, IRL790 goes by the International Nonproprietary Name (INN), mesdopetam. The World Health Organization (WHO) concluded that IRL790 is unique in its mechanism of action and assigned a new INN, mesdopetam, that can become a new substance class in the existing classification system for pharmaceutical substances. The INN will serve to identify the active pharmaceutical substance of mesdopetam during its lifetime worldwide.

Solid intellectual property rights

Exclusivity based on patents

Mesdopetam has an approved substance patent in all major markets worldwide. The patent application was submitted in 2012 and provides protection for at least 20 years. Provided the regulatory requirements are met, the patent protection can be extended at most until 2037 in the US, Europe and Japan. A new composition of matter patent application was published by World Intellectual Property Organization (WIPO) in 2020. If this new patent application is granted, the patent will expire in 2040.

Potential grants of supplementary protection certificate (SPC) or patent term extension (PTE), exclusivity can potentially be prolonged into the 2040s for mesdopetam.*

Exclusivity based on regulatory data protection

Independent of the patent-based exclusivity periods mesdopetam will also enjoy customary market exclusivity, for ten years from market approval in Europe and five years from market approval in the US, based on regulatory data exclusivity as a new chemical entity (NCE).

* A medicinal product can only be granted an SPC/PTE extension for one patent.

Phase IIb trial

Read the top-line results of the Phase IIb trial in people with Parkinson’s experiencing troublesome dyskinesia caused by their levodopa treatment (PD-LIDs).

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