Peptimmune Completes Phase Ib Study Of PI-2301

Peptimmune has completed phase Ib study of PI-2301. The trial was conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301, in subjects with Secondary Progressive Multiple Sclerosis (SP-MS).

PI-2301 is a novel peptide copolymer meant for the treatment of multiple sclerosis and other autoimmune diseases.

The phase Ib multiple-ascending dose, double-blind, placebo-controlled, randomized study enrolled 50 subjects with SP-MS.

Reportedly, a total of 36 subjects has received PI-2301 once weekly for eight weeks, followed by an open label extension of an additional four weeks.

The company plans to continue developing the compound by initiating a phase II study in multiple sclerosis patients later this year.

Moreover, the data from the phase Ib study will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on September 10, 2009.

Thomas Mathers, president and CEO of Peptimmune, said: PI-2301 has now shown safety and pharmacologic activity in two clinical studies, the first in healthy volunteers, and this second in patients with multiple sclerosis. As we look forward to the Phase II, we are excited about the observed pharmacologic effects of PI-2301 in patients suffering from secondary progressive MS.