IRLAB Concludes Positive FDA Meeting on Mesdopetam's Phase III Plan

IRLAB Therapeutics, a Swedish company dedicated to advancing treatments for Parkinson's disease, has reported a positive outcome from its recent discussions with the US Food and Drug Administration (FDA). These talks, which centered on the design of a Phase III program for the drug mesdopetam, were described as constructive and collaborative.

During the meeting, IRLAB shared with the FDA extensive data on mesdopetam, encompassing preclinical studies, toxicology, clinical pharmacology, and the results from Phase Ib, IIa, and IIb trials. This information was critical in shaping the proposal for the drug's continued development. The FDA's feedback was in line with IRLAB's proposed design for the Phase III program, with consensus reached on primary and secondary endpoints, patient eligibility criteria, and safety monitoring procedures.

Gunnar Olsson, CEO of IRLAB, expressed satisfaction with the alignment achieved with the FDA, noting that the work conducted thus far meets the necessary standards for advancing mesdopetam into a definitive clinical Phase III trial. Further details regarding the study will be disclosed following the FDA's formal feedback, which IRLAB expects to receive within 30 days post-meeting.

Mesdopetam, a dopamine D3 receptor antagonist, is under development to address levodopa-induced dyskinesias (PD-LIDs) in Parkinson's disease patients. PD-LIDs are involuntary movements that occur in approximately 25-40 percent of those treated with levodopa, affecting an estimated 1.4-2.3 million people globally. Mesdopetam has also shown potential in treating Parkinson's disease Psychosis (PD-P) and other neurological conditions, indicating a broader market opportunity. The drug has demonstrated a favorable safety profile and tolerability in previous studies, with Phase IIb results indicating a dose-dependent therapeutic effect with a safety profile comparable to placebo.

IRLAB, which was born out of Nobel Laureate Prof. Arvid Carlsson's research, is also progressing other Parkinson's disease therapies, including Pirepemat in Phase IIb for balance and fall frequency, and three preclinical programs supported by the Michael J. Fox Foundation. The company's pipeline is driven by its Integrative Screening Process (ISP) research platform, a systems biology-based approach.

IRLAB is headquartered in Sweden and is listed on Nasdaq Stockholm under the ticker IRLAB A. The company's commitment to developing transformative therapies for Parkinson's disease is evident through its ongoing research and development efforts and its collaborative approach with regulatory bodies such as the FDA.