BioCryst Lead Compound Demonstrates Efficacy in the Treatment of Psoriasis and Severe Form of Skin Cancer in Phase II Clinical Trials.

BIRMINGHAM, AL--(HealthWire)--February 6, 1995--BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that a topical formulation of its lead compound, BCX-34, showed evidence of efficacy and safety in two separate Phase II clinical studies for the treatment of two serious skin diseases, psoriasis and cutaneous T-cell lymphoma (CTCL).

Psoriasis is a chronic disease, affecting approximately 5 million people in the U.S., and is characterized by development of thick, scaly, itchy patches or welt-covered areas of skin. CTCL is a form of cancer in which thick, scaly lesions on the skin progress to ulcers and tumors of the lymph nodes and internal organs. There are approximately 5,000 patients in the U.S. affected by CTCL. Therapies currently available for both of these diseases are ineffective or have undesirable side effects.

The Phase II clinical trials, involving 40 patients with psoriasis and 30 patients with CTCL, evaluated the effectiveness of topical formulations containing concentrations of BCX-34 ranging from 5 percent to 0.1 percent. A severity scoring system of relevant symptoms ("global score") resulted in a greater than 50 percent improvement of lesions after a six-week treatment course, even at the lowest doses of drug. The global score is a summary evaluation of thickness, inflammation, scaling and patient response. The global scores for both trials were statistically significant compared to the effects associated with application of the base cream alone to comparable lesions in the same patients. These Phase II trial outcomes are not necessarily predictive of the results of future trials for these indications.

"Both of these trials provided encouraging results for BCX-34," said William J. Cook, M.D., Ph.D., vice president of Medical Affairs at BioCryst. "Responses were observed in both studies after only one week of treatment. We are particularly excited about the marked clearing of CTCL lesions within six weeks of treatment: three test lesions cleared completely and there was an overall average reduction of 55 percent in lesion area. We look forward to our next stage of clinical trials, which are designed to establish optimal dosing and treatment regimens."

"In addition to the positive efficacy data, these studies showed no significant irritative or other side effects associated with continuous use of BCX-34 Dermal Cream. We believe that this compound's strong safety profile will prove beneficial when testing the drug in extended usage trials," said Charles E. Bugg, Ph.D. chairman and CEO of BioCryst. "We are also in the process of gathering preliminary safety and efficacy data with oral and intravenous formulations of BCX-34 for CTCL and psoriasis, as well as our other targeted indications."

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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205/444-4600

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