MultiCell has scheduled a meeting with the Medicines and Healthcare Products Regulatory Agency to present its clinical development plan for MCT-125. Additionally, the company will request permission to initiate its phase IIb trial of MCT-125.
“The purpose of the proposed phase IIb dose-ranging trial is to determine the minimum efficacious dose for MCT-125 prior to commencing a pivotal phase III trial. The initial phase II trial conducted by Amarin only determined a single efficacious dose, and we need to know a range over which MCT-125 will remain effective,” said Dr Stephen Chang, CEO of MultiCell.
According to MultiCell, about two million people worldwide are afflicted with MS, and approximately 70% of them report fatigue as the worst symptom of their disease.
MCT-125 has already completed a phase II clinical trial and demonstrated significant efficacy in reducing chronic fatigue in multiple sclerosis patients. There is no drug specifically approved for the treatment of chronic fatigue in multiple sclerosis patients.