BioCryst initiates clinical trials for topical and oral formulations of BCX-34 for Psoriasis.

BIRMINGHAM, Ala.--(Health Wire)--November 6, 1996--BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the initiation of two clinical trials using topical and oral formulations of its lead immunosuppressive drug candidate, BCX-34. The Company has initiated a Phase III clinical trial with a topical formulation of BCX-34, and a Phase I/II dose escalation trial with an oral formulation of BCX-34, each for the treatment of psoriasis. BCX-34 is a small-molecule inhibitor of purine nucleoside phosphorylase (PNP), a human enzyme that is believed to be involved in the proliferation of T-cells.

"There is a clear demand for a safe and effective psoriasis treatment. We feel that BCX-34's ability to inhibit abnormal T-cell proliferation associated with psoriasis holds promise to offer therapeutic relief to people affected by this disorder," said Charles E. Bugg, Ph.D., President and CEO of BioCryst. "By developing both topical and oral formulations of BCX-34, our goal is to provide a variety of formulations to treat different stages of psoriatic disease progression."

The Phase III double-blind, randomized, placebo-controlled trial using the topical formulation will treat 350 patients with plaque psoriasis for 16 weeks with a topical cream containing a one percent drug concentration of BCX-34. The trial will have two parallel patient groups of equal size, one receiving drug and the other receiving placebo, and will be administered at 15 clinical research centers throughout the United States. This trial is being managed by Quintiles.

In the Phase I/II trial, cohorts of three to five patients with moderate to severe stable plaque psoriasis will be dosed with oral BCX-34. Patients in the initial cohort will receive a daily dose totaling 40mg (20mg per dose twice daily) for 56 consecutive days. Over the course of the trial, subsequent cohorts of three to five patients will receive a higher dose level, until the maximum tolerated dose is obtained. This is BioCryst's first human trial using oral BCX-34 for the treatment of psoriasis. The study, which is being conducted at Emory University in Atlanta, GA, is designed to obtain safety, pharmacology and biological data.

Psoriasis is a chronic and recurrent disease characterized by itchy, thick scaling or welt-covered portions of the skin. An estimated five million people in the United States are affected by psoriasis. Current therapies for psoriasis are generally of limited benefit or associated with side effects.

The Company is currently conducting a multi-center Phase III clinical trial with topical BCX-34 for the treatment of cutaneous T-cell lymphoma (CTCL), a Phase I/II clinical trial with an oral formulation of BCX-34 to treat T-cell cancers and a Phase I/II trial with topical BCX-34 for the treatment of atopic dermatitis. These diseases and others, including rheumatoid arthritis, are associated with the proliferation of T-cells.

Founded in 1986, BioCryst Pharmaceuticals, Inc. designs and develops novel, small-molecule pharmaceuticals using structure-based drug design, an approach to drug discovery that integrates advanced biology, biophysics and medicinal chemistry. BioCryst's lead drug, BCX-34, is in clinical trials with both topical and oral formulations. The Company is developing drug treatments for immunological and viral diseases.

This press release contains projections or other forward-looking statements regarding future events or the future financial performance of the Company. These statements are only predictions and the actual events or results may differ materially. Please refer to the documents BioCryst files from time to time with the Securities and Exchange Commission, specifically BioCryst's most recent Form 10-K and Form 10-Q. These documents contain and identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.

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