Axys Pharmaceuticals, Inc. Discontinues Early Stage Clinical Program in Psoriasis
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Nov. 18, 1999--
Additional Clinical and Preclinical Studies Ongoing
in Proprietary Class of Tryptase Inhibitors
Axys Pharmaceuticals, Inc. (Nasdaq:AXPH) today announced that it has discontinued further development of a topical cream-based formulation of APC-2059 for psoriasis based on results from a planned interim evaluation of the phase II study initiated in May 1999.
The study was a randomized double blind placebo controlled trial, with each patient serving as his own control. The protocol was designed to be conducted in two stages, with an interim analysis scheduled at the end of the first stage.
This analysis revealed that there was no difference between placebo and treated sites of skin disease in the 12 patients enrolled in the first stage. Based on the conclusive finding, the company has discontinued further work in this indication.
The company also announced that it has successfully completed Phase Ic studies of APC 2059, an injectable formulation of APC 2059 for the treatment of ulcerative colitis. This trial showed that, at the planned Phase II dose administered by subcutaneous injection, the drug is well tolerated and produces the desired blood concentrations in normal volunteers.
The company is now embarking on a Phase II study in patients with ulcerative colitis, which is designed in two stages, in order to provide an opportunity for an interim analysis of efficacy results. It is anticipated that this decision point will be reached during the first half of 2000.
APC 2059 is a proprietary Axys compound and a member of a class of synthetic small molecule compounds designed to inhibit tryptase, an enzyme found in mast cells. Mast cells have been demonstrated to be involved in inflammatory diseases.
APC 2059 is a second-generation tryptase inhibitor that does not exhibit oral bioavailability, and thus was chosen as the development candidate for topical and parenteral indications.
The company has been developing in parallel multiple generations of small molecule tryptase inhibitors as a new class of compounds to treat a variety of inflammatory disorders. The company's collaborative partner, Bayer AG of Leverkusen, Germany, is currently developing an orally bioavailable tryptase inhibitor, BAY 44-3428, for the treatment of asthma, targeted to enter human dosing in 2000.
Previous clinical trials with a first-generation peptidomimetic tryptase inhibitor in asthma had demonstrated that inhibition of this enzyme can produce measurable clinical benefit in humans.
"The psoriasis trial was designed to provide a clear decision point using a minimum amount of resources, and we accomplished that result," commented Dr. Dan Hoth, Axys' senior vice president of development and chief medical officer.
"In regard to ulcerative colitis, there is a significant amount of published data to suggest that mast cells, and tryptase in particular, could play a role in this disease, supporting the development of the injectable form of APC 2059 for this indication through a Phase II study. The phase II trial has been designed to provide an early go, no-go decision point with a minimum of patients, time, and resources."
Axys Pharmaceuticals is a drug discovery and development company with a proprietary focus in oncology. Axys is building shareholder value through (1) a broad and diversified pipeline of research and development programs partnered with world-class pharmaceutical companies; (2) expansion of a non-partnered research and development franchise in oncology; and (3) the spin out of affiliated businesses that leverage the company's technologies in order to provide capital for Axys' drug discovery and development programs.
Axys' technology-leveraging businesses are: Axys Advanced Technologies, a combinatorial chemistry oriented business; PPGx, a majority owned pharmacogenomics company; and Akkadix, an agricultural biotechnology company.
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, the 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 and marketing risk, 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 "What Factors Could Cause Our Results to Differ Significantly from Those You Might Expect?" and "Additional Risk Factors" in the company's SEC Reports, including the company's report on Form 10-K for the fiscal year ended Dec. 31, 1998.
For more information on Axys Pharmaceuticals, Inc., please visit the company's website at axyspharm.com.
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CONTACT:
Axys Pharmaceuticals Inc., South San Francisco
John Walker or Daniel Hoth, M.D., 650/829-1000
www.axyspharm.com |
