FDA Endorses IRLAB's Phase III Plan for Mesdopetam

IRLAB Therapeutics, a company focused on the development of innovative treatments for Parkinson's disease, has received encouraging feedback from the US Food and Drug Administration (FDA) regarding its drug candidate, mesdopetam. The company has been given the green light to proceed with preparations for a Phase III clinical trial program based on the positive written minutes from a recent End-of-Phase 2 meeting.

The FDA's feedback has validated the quality of IRLAB's development activities and confirmed the alignment with the agency on several key components of the Phase III program. The patient population will continue to reflect those included in previous clinical studies, with the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS) parts 1+3+4. Secondary endpoints will be derived from subsections of the UDysRS and MDS-UPDRS, along with 24-hour motor diaries. The estimated sample size for the Phase III trial is projected to be between 200 and 250 patients, with a treatment duration of three months. The dosage to be evaluated is 7.5 mg twice daily, and safety documentation will require a minimum of 100 patients treated with the relevant dose for one year in the safety extension of the Phase III program.

Significantly, the Phase IIb study of mesdopetam had already demonstrated a significant anti-dyskinetic effect at the dosage of 7.5 mg twice daily, as compared to a placebo, using the specific UDysRS assessment scale.

Gunnar Olsson, the CEO of IRLAB, expressed his satisfaction with the FDA's formal minutes, which confirm the plans for the Phase III program and validate the quality of IRLAB's development efforts. He noted that the extensive work by IRLAB's team has met the regulatory requirements to advance mesdopetam into a confirmatory clinical Phase III program.

Following the positive feedback, IRLAB is continuing preparations for the Phase III program and will engage with European regulatory agencies as part of the standard procedure before initiating the trial.

Mesdopetam, an investigational drug and a dopamine D3 receptor antagonist, is being developed to treat levodopa-induced dyskinesias in Parkinson's disease. The drug aims to enhance the quality of life for those suffering from involuntary movements, a common side effect of long-term levodopa treatment. It also holds potential for treating Parkinson's disease psychosis and other neurological conditions, indicating a broader market potential. Previous studies have shown mesdopetam to have a good safety profile and a promising anti-dyskinetic effect.

IRLAB is committed to discovering and developing a range of transformative therapies for Parkinson's disease at all stages. The company's pipeline is driven by its proprietary Integrative Screening Process (ISP) research platform. With its origins in Nobel Laureate Prof. Arvid Carlsson's research group, IRLAB is dedicated to advancing the understanding of the brain's neurotransmitters and their connection to CNS disorders. The company's headquarters are in Sweden, and it is listed on Nasdaq Stockholm.