Peptimmune Initiates Phase Ib Multiple Sclerosis Study
Peptimmune has treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with secondary progressive multiple sclerosis.
The Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study will involve up to 53 subjects with secondary progressive multiple sclerosis who will receive the drug once weekly in four escalating-dose cohorts.
Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the company plans to initiate its Phase II study in multiple sclerosis patients in early 2009.
PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
Thomas Mathers, president and CEO of Peptimmune, said: “While the primary goal of this study is to demonstrate safety of PI-2301 in multiple sclerosis patients, we believe that this clinical trial is one of the most comprehensive looks at the pharmacologic effects of any immunomodulator in patients suffering from autoimmune diseases.”