IRLAB Receives Minutes From End-of-Phase 2 Meeting Confirming Alignment with the FDA on the Phase III Program For Mesdopetam - Seite 2

"Following the successful End-of-Phase 2 meeting for mesdopetam, we are now delighted to conclude that the FDA's formal meeting minutes confirm our plans for Phase III and validate the quality of our development activities. It is gratifying to see that the extensive work carried out by Irlab's experienced team meets the requirements of the regulatory authority to move mesdopetam into a confirmatory clinical Phase III program," said Gunnar Olsson, CEO, IRLAB.

Based on the positive feedback from the FDA, IRLAB continues the preparations for the Phase III program and will now engage with European regulatory agencies in accordance with standard practice before initiation of the Phase III program.

For more information

Gunnar Olsson, CEO
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Nicholas Waters, EVP and Head of R&D
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About mesdopetam

The investigational drug mesdopetam (IRL790), a dopamine D3 receptor antagonist, is being developed as a treatment for Parkinson's disease levodopa-induced dyskinesias (PD-LIDs). The objective is to improve the quality of life for people living with Parkinson's and having a severe form of involuntary movements commonly occurring after chronic levodopa treatment. Around 25-40 percent of all people being treated for Parkinson's develop LIDs, which equates to approximately 1.4-2.3 million people in the eight major markets globally (China, EU5, Japan and the US). Mesdopetam has also potential as a treatment for Parkinson's disease Psychosis (PD-P), and other neurological conditions such as tardive dyskinesia, representing an even larger market. The Phase Ib and Phase IIa studies showed a good safety and tolerability profile as well as proof-of-concept with potential for a better anti-dyskinetic effect compared with current treatment options. A Phase IIb study, completed in 2023, showed that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect in combination with a tolerability and safety profile on par with placebo. The mesdopetam program is now undergoing preparations for Phase III.