A phase II trial demonstrated reduction in enhancing magnetic resonance imaging lesions in patients with multiple sclerosis.
Firategrast is an investigational, orally administered monoclonal antibody that selectively targets α4β-integrins — a target similar to that of natalizumab therapy. For this phase II, industry-sponsored, multicenter trial, researchers randomized 343 patients with relapsing-remitting multiple sclerosis (MS) to receive twice-daily placebo or firategrast at low dose (150 mg), middle dose (600 mg), or high dose (900 mg for women,1200 mg for men).
Active treatment lasted 24 weeks. Planned follow-up lasted at least 12 weeks; follow-up for safety monitoring lasted up to 40 weeks longer. The primary endpoint was the reduction of gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) at 24 weeks. Secondary endpoints included reduction…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)