IRLAB has Completed a Successful End-of-Phase 2 Meeting with the FDA on the Design of the Phase III Program for Mesdopetam - Seite 2

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 recently completed Phase IIb study 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.

Attachments

IRLAB has completed a successful End-of-Phase 2 meeting with the FDA on the design of the Phase III program for mesdopetam

SOURCE: IRLAB Therapeutics

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The IRLAB Therapeutics Stock at the time of publication of the news with a fall of -8,73 % to 1,150EUR on Frankfurt stock exchange (22. Februar 2024, 08:17 Uhr).