FDA End-of-Phase 2 Meeting for IRLAB's Mesdopetam Program

Swedish pharmaceutical firm IRLAB Therapeutics, known for its work on innovative treatments for Parkinson's disease, has received a significant boost with the US Food and Drug Administration (FDA) scheduling an end-of-Phase 2 meeting for its mesdopetam program. Scheduled for February 20, 2024, this meeting is a critical juncture in the drug development process, as it will provide a platform for IRLAB to discuss the next steps for mesdopetam, including the design of Phase III trials and the eventual path towards a New Drug Application (NDA).

The CEO of IRLAB, Gunnar Olsson, has highlighted the importance of this meeting, stating that it will not only shape the future development of mesdopetam but also play a crucial role in the company's business development strategies. To prepare for this pivotal meeting, IRLAB has collaborated with Clintrex, a clinical and regulatory strategy consultant, and ProPharma Group (PPG), its regulatory representative in the US. Together, they have compiled a comprehensive Briefing Book that outlines the clinical and non-clinical development program for mesdopetam and details the planned Phase III study design.

The purpose of an end-of-Phase 2 meeting with the FDA is to ensure that all parties are aligned before proceeding to Phase III. During this meeting, the FDA will assess the Phase III plans, study protocols, and data from previous studies to evaluate the safety and efficacy of the drug candidate. They may also indicate if additional information is needed to support a future NDA.

IRLAB's mesdopetam, an investigational drug that targets the dopamine D3 receptor, is being developed to treat levodopa-induced dyskinesias in Parkinson's disease patients. The condition affects a significant number of Parkinson's patients who have been on long-term levodopa treatment, with estimates suggesting that around 25-40 percent of these individuals develop dyskinesias. This translates to a potential patient population of 1.4-2.3 million people in the major global markets. Mesdopetam has also shown promise as a treatment for Parkinson's disease psychosis and other neurological disorders, indicating a broader market potential.

Clinical trials for mesdopetam have demonstrated a positive safety and tolerability profile, with Phase Ib and IIa studies providing proof-of-concept for its potential anti-dyskinetic effects. A recent Phase IIb study involving 156 patients confirmed mesdopetam's dose-dependent efficacy in reducing dyskinesias and Parkinsonian symptoms, with a tolerability and safety profile comparable to placebo.

IRLAB, founded on the research of Nobel Laureate Prof. Arvid Carlsson, is committed to developing transformative therapies for all stages of Parkinson's disease. The company's pipeline includes mesdopetam, which is advancing towards Phase III, as well as pirepemat, currently in Phase IIb trials for its impact on balance and fall frequency in Parkinson's disease. Additionally, IRLAB is advancing three preclinical programs towards Phase I studies, supported by its proprietary Integrative Screening Process (ISP) research platform.

As IRLAB gears up for the end-of-Phase 2 meeting with the FDA, the company is poised to take a significant step forward in its mission to bring innovative treatments to patients suffering from Parkinson's disease and related neurological conditions. The outcome of the meeting will be shared once IRLAB receives feedback from the FDA, which may take up to 30 days post-meeting.