Axys Pharmaceuticals Advances Clinical Development of APC 2059 in Both Psoriasis and Acute Inflammatory Bowel Disease
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Feb. 11, 1999--Axys Pharmaceuticals, Inc. (Nasdaq:AXPH) today announced it has initiated Phase Ib studies of APC-2059 in two indications: as a topical cream formulation for the treatment of psoriasis, and as an injectable formulation for the treatment of acute inflammatory bowel disease (IBD). The company has successfully completed Phase Ia studies of APC 2059 for both psoriasis and IBD. APC 2059 is a proprietary Axys compound and a member of a class of compounds designed to inhibit tryptase, an enzyme found in mast cells which has been demonstrated to be involved in inflammatory diseases.
John Walker, chairman and CEO of Axys, stated, "Normally we would not report on the progression of a clinical program from Phase Ia to Phase Ib status. However, the clear safety profile of our synthetic drug candidate, APC 2059, observed in the Phase Ia trials reaffirmed our confidence that APC 2059 warrants further clinical development. Our results with APC 2059 indicate that the compound has a very favorable physicochemical and pharmacokinetic profile that will allow us to freely examine its therapeutic potential. We also continue to strongly believe that tryptase is a validated target in inflammation, and that tryptase inhibitors as a class, represent a significant opportunity for the company. In addition to these two tryptase inhibitor programs, Axys remains enthusiastic about the progress of our oral tryptase inhibitor program for the treatment of asthma. Our partner in that program, Bayer AG, recently nominated BAY 44-3428 for clinical development, which was created using Axys' proprietary Delta technology."
The Phase Ia studies of topical APC 2059 for psoriasis and an injectable form for IBD were double-blind, placebo-controlled clinical trials designed to evaluate the safety, tolerability and delivery characteristics of ascending single doses of APC 2059 in healthy subjects.
The Phase Ib clinical trial of APC 2059 for psoriasis has been designed as a double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability and transcutaneous absorption of multiple doses of a topically administered cream formulation of APC 2059 in 20 healthy subjects.
Psoriasis is an autoimmune skin disorder resulting in excessive skin cell reproduction. The disease has several different clinical presentations that are most often characterized by raised, inflamed lesions covered with a scaly white buildup of dead skin cells. Nearly seven million people in the U.S. suffer from various forms of psoriasis, however, none of the current treatments, including topical steroids and immunosuppressants offer consistent relief.
The Phase Ib clinical trial of APC 2059 for the treatment of IBD has been designed as a multiple dose study of the tolerability, safety and pharmacokinetics of an injectable formulation of APC 2059 in 18 healthy subjects.
Inflammatory bowel disease generally refers to two diseases, Crohn's disease and ulcerative colitis. Over 500,000 people in the U.S. suffer from IBD, however, current therapies, which include the use of corticosteroids and immunosuppressants such as cyclosporine and methotrexate, expose patients to significant long-term side effects.
Axys Pharmaceuticals is a leader in the integration of life science technologies with a focus on transforming gene discoveries to drugs. The company has research collaborations with world-class pharmaceutical companies, covering a broad range of therapeutic areas, including respiratory, cardiovascular, metabolic, and infectious disease, as well as oncology and central nervous system disorders.
Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties which could cause Axys' actual results to differ materially from those discussed here, including Axys' reliance on the efforts of its collaborative partners, the risk that Axys' collaborations will not be successful, risk that clinical trials will not proceed as anticipated or may not be successful, the risk of Axys' early stage of development, the risk that Axys will not be successful in entering into new collaborations, competition, the risk of unexpected difficulties and delays in the development of new technologies and in expanding its manufacturing capabilities, and general economic conditions that may affect Axys' actual results and developments. Additional factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections entitled "Business" and "Additional Risk Factors" in the company's SEC Reports, including the company's report on Form 10-K for the fiscal year ended December 31, 1997.
For more information on Axys Pharmaceuticals, Inc., please visit the company's website at axyspharm.com.
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