Clinical Trials
PI-0824 is Currently in Phase II
PI-0824 is currently in phase II development for the treatment of pemphigus vulgaris, a rare autoimmune disease of the skin and mucosa.
Peptimmune is developing PI-0824 along with its European-only development partner Orphan Europe, a division of Recordati (Milan, Italy). PI-0824 has received Orphan Drug designation. This treatment has the potential of being the safest and most targeted therapy available for this underserved patient population. Current therapy consists of very high daily doses of corticosteroids. A phase I/II study has been completed in fifteen pemphigus vulgaris patients and PI-0824 was found to safe and tolerable. Phase II development is being conducted at multiple sites in France.
PI-2301 is currently in phase Ib development and is a second-generation copolymer for multiple sclerosis (MS), Crohn’s disease, uveitis, and potentially neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS). A Phase Ia safety and pharmacokinetic study has been completed, and all doses of PI-2301 have been found to be safe and well tolerated, along with evidence of bioactivity. Peptimmune has initiated a twelve-week phase Ib MS patient study Q2/2008. This study will confirm repeat-dose safety and proof of pharmacologic mechanism for PI-2301. Phase Ib development is being conducted at multiple sites in France.
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