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IRLAB has completed a successful End-of-Phase 2 meeting with the FDA on the design of the Phase III program for mesdopetam
Kurs & Likviditet
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Gothenburg, Sweden, 22 February 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company's recent End-of-Phase 2 meeting with the US Food and Drug administration, FDA, was held in a constructive and engaging spirit. The discussions during the meeting indicate alignment between the FDA and IRLAB on the design of the Phase III program.
At the End-of-Phase 2 meeting with the FDA, aspects related to the Phase III program with mesdopetam were discussed. Prior to the meeting, IRLAB had provided the FDA with comprehensive information on mesdopetam generated through preclinical studies, toxicology, clinical pharmacology, and the outcomes of the clinical Phase Ib, Phase IIa and Phase IIb studies conducted in people living with Parkinson's and levodopa-induced dyskinesias. A proposal for the further development of mesdopetam was included in the information package.
Based on this information, the FDA provided clear guidance that is substantially consistent with the proposed design of the Phase III-program for mesdopetam. Alignment with the FDA was reached on the key components of the Phase III program, including the primary and secondary endpoints, key inclusion and exclusion criteria and safety monitoring during the study period.
“We had a very good meeting with the FDA where we reached alignment on the final design of the Phase III program for mesdopetam. It is gratifying to see that the extensive work with exploratory as well as mandatory regulatory studies that has been carried out meets requirements to move mesdopetam into a confirmatory clinical Phase III program," said Gunnar Olsson, CEO, IRLAB.
More information about the study program will be communicated once the FDA has provided its formal feedback in the form of the official meeting minutes. IRLAB will receive the meeting minutes no later than 30 days after the meeting.