BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a US pivotal phase-III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.
Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process.
"Our receipt of fast track designation for dirucotide in the U S is a significant milestone for both BioMS Medical and the MS community," said Kevin Giese, president and CEO of BioMS Medical. "Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options."
Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). Dirucotide is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies.