Pipeline

Overview
Asphelia Pharmaceuticals has a robust pipeline of immunological therapeutics and plans to initiate three Phase IIa clinical trials in 2008.

Compounds
ASP1002 is a helminth (worm) technology that is currently being developed for the treatment of Crohn's Disease, and later Ulcerative Colitis. When the human body detects helminthes, it triggers an immunological response that has a positive impact on these diseases and essentially rebalances the immune system. Already more than 100 patients in Europe and the USA have taken helminthes (worm) eggs orally without significant safety issues. We expect to begin a Phase IIa clinical trial in patients with Crohn’s Disease in the third quarter of 2008 and complete the study by the end of the year.

ASP2002 is a novel, oral compound administered once-daily that targets integrins in order to treat immunological and inflammatory disorders. In animal models of colitis, the compound has been shown to decrease colonic inflammation with the same effect as corticosteroids. This holds particular promise to patients, as corticosteroids cannot be taken for long periods of time. Phase I data show that single doses up to 180mg and repeated doses up to 40mg per dose are safe and well tolerated. We currently have an effective IND for ASP2002. We are currently consulting with our advisors regarding the protocol for a Phase IIa clinical trial in patients with mesalamine-refractory Ulcerative Colitis, and will continue to evaluate this and other indications for the development of Y803.

ASP1001 is a topical formulation of iodinated contrast media being developed for the treatment of allergic disorders. This technology is based on the observation that iodinated contrast media, when given topically at high concentration, inhibits the release of histamine. We plan to initiate a Phase IIa study in allergic rhinitis in early 2008, and initiate the preclinical activities necessary for further development and registration. Potential indications include allergic rhinitis, allergic conjunctivitis, atopic dermatitis and eosinophilic esophagitis.