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IP-1001 for Crohn’s Disease
Crohn’s disease is an inflammatory disease of the gastrointestinal tract characterized by chronic, recurring and painful symptoms. Approved treatments include corticosteroids, immunosuppressants and biologics, all of which produce serious unwanted side-effects. Crohn’s disease affects between 700,000 and 1,000,000 Americans with an estimated yearly market of over $2 billion worldwide.
In an independent pilot study, 6 of 7 Crohn’s disease patients as well as 8 of 13 colitis patients responded to 8 weeks of treatment with 200 mg of micronized DHEA. Ulcerative colitis patients from this study also showed higher DHEAS levels which correlated with lower disease activity.
Phase 1 studies that evaluated the safety and tolerability of IP-1001, a proprietary oral DHEA formulation, and its pharmacokinetics have been completed. In these studies, IP-1001 was found to be safe, well-tolerated, and more bioavailable than micronized DHEA.
A Phase 2 dose-response study evaluating the efficacy of IP-1001 in reducing the signs and symptoms of Crohn’s disease is scheduled to begin in fourth quarter of 2004 with completion expected in fourth quarter of 2005.
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