Dirucotide (MBP8298) is currently being evaluated in a US pivotal Phase III trial, named Maestro-03, at 68 sites with approximately 510 patients.
Kevin Giese, president and CEO of BioMS Medical, said: “Our receipt of fast track designation for dirucotide in the US is a significant milestone for both BioMS Medical and the multiple sclerosis community.
“Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive multiple sclerosis patients, a large patient population with very limited treatment options.”