BioCryst initiates expanded Phase II clinical trial for psoriasis with topical BCX-34.

BIRMINGHAM, Ala.--(HealthWire)--November 8, 1995--BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has initiated an expanded Phase II clinical trial with the topical formulation of its lead drug, BCX-34, for the treatment of psoriasis.

The Phase II double-blind, randomized, placebo-controlled trial will treat 90 patients with plaque psoriasis for three months with a topical cream containing a one percent drug concentration of BCX-34. The primary clinical endpoints for this trial are reductions of erythema, thickness and scaling of lesions. The trial will have two parallel patient groups of equal size, one receiving drug and the other receiving placebo, and will be administered at four clinical research centers in the United States.

"Results of a previous topical six-week Phase II clinical trial suggested that a one percent concentration of BCX-34 was the most efficacious as compared to other concentrations, and indicated the most favorable response versus placebo," said William J. Cook, M.D., Ph.D., Senior Vice President, Research and Development and Medical Director at BioCryst. "We expect that this trial's rigid controls, larger patient group and extended treatment period will give us an accurate indication of topical BCX-34's efficacy for treating psoriasis."

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 ineffective or associated with side effects.

"We are pleased to be advancing our clinical program with this major autoimmune disease," said Charles E. Bugg, Ph.D., President and CEO of BioCryst. "There is significant demand for a safe and effective psoriasis treatment. With BCX-34's novel biochemical mechanism, we are hopeful that our drug will provide the therapeutic relief desperately needed by patients."

BioCryst recently reported results of a six-month clinical trial of the topical formulation of BCX-34 which showed evidence of efficacy for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has initiated a multi-center Phase III clinical trial to treat 90 CTCL patients with topical BCX-34. In addition, BioCryst is planning to conduct a Phase I/II dose escalation trial for the treatment of CTCL and T-cell leukemia using an oral formulation of the drug. These diseases and others, such as rheumatoid arthritis and multiple sclerosis, are associated with an abnormal proliferation of T-cells. BCX-34 is a potent, small-molecule inhibitor of purine nucleoside phosphorylase (PNP), a human enzyme that plays a central role in the proliferation of T-cells. BCX-34 was granted Orphan Drug Status in October 1993 for CTCL, and qualifies for accelerated review as a new drug to treat life-threatening and severely debilitating illnesses.

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 is currently applying this approach to develop drug treatments for autoimmune and cardiovascular disorders and infectious diseases.

CONTACT: BioCryst Pharmaceuticals, Inc.

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