FDA Approves Phase II Conclusion Meeting for IRLAB's Mesdopetam Program

IRLAB Therapeutics, a Swedish firm dedicated to advancing treatments for Parkinson's disease, has received a significant boost in its development process. The US Food and Drug Administration (FDA) has scheduled an end-of-Phase 2 meeting for the company's mesdopetam program, set to take place on February 20, 2024. This meeting is a pivotal step for the program, as it will facilitate discussions on the progression to Phase III and potentially set the stage for a New Drug Application (NDA) in the future.

The CEO of IRLAB, Gunnar Olsson, has emphasized the importance of this meeting, stating that it will be instrumental in shaping the company's business development strategy for mesdopetam. To prepare for this crucial meeting, IRLAB is collaborating with Clintrex, a clinical and regulatory strategy consultancy, and ProPharma Group (PPG), serving as IRLAB's regulatory agent in the US. Together, they have developed a comprehensive Briefing Book that outlines the clinical and non-clinical development program of mesdopetam, as well as the design of the proposed Phase III program.

The purpose of the end-of-Phase 2 meeting is to ensure that there is a clear understanding and alignment with the FDA before the commencement of Phase III trials. During this meeting, the FDA will review the plans and protocols for Phase III, along with the data from previous studies, to assess the safety and efficacy of the drug candidate. Additionally, the FDA may indicate if there is a need for any further information to support an NDA.

IRLAB will provide an update on the outcome of the meeting once they have received feedback from the FDA, which could take up to 30 days post-meeting.

Mesdopetam, the drug under development, is a dopamine D3 receptor antagonist aimed at treating levodopa-induced dyskinesias in Parkinson's disease patients. The goal is to enhance the quality of life for those suffering from severe involuntary movements that often occur following long-term levodopa treatment. It is estimated that 25-40% of Parkinson's patients treated with levodopa develop these dyskinesias, affecting approximately 1.4-2.3 million people globally in the eight major markets. Mesdopetam has also shown promise as a potential treatment for Parkinson's disease Psychosis and other neurological conditions, indicating a broader market potential. Phase Ib and IIa studies have demonstrated a favorable safety and tolerability profile, along with proof-of-concept for its anti-dyskinetic effects. A recent Phase IIb study involving 156 patients confirmed mesdopetam's dose-dependent efficacy and tolerability, comparable to placebo.

IRLAB is focused on discovering and developing innovative therapies for all stages of Parkinson's disease. Originating from the research group of Nobel Laureate Prof. Arvid Carlsson, the company leverages a connection between brain neurotransmitters and CNS disorders. In addition to mesdopetam, which is now preparing for Phase III, IRLAB is also advancing pirepemat, currently in Phase IIb, for its potential impact on balance and fall frequency in Parkinson's disease. Furthermore, the company is progressing three preclinical programs towards Phase I studies, supported by its proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is publicly traded on Nasdaq Stockholm under the ticker IRLAB A.