By Debbie Strickland
Seven months after a Phase III setback, BioCryst Pharmaceuticals Inc. got a second dose of bad trial news in Phase II trial data for its lead product, a topical cream formulation of BCX-34.
In the Phase II plaque psoriasis study, the cream failed to beat placebo in primary study endpoints. Last year, the drug failed at Phase III to achieve statistical significance in treating cutaneous T-cell lymphoma and psoriasis. (See BioWorld Today, Sept. 29, 1997, p. 1.)
BCX-34 inhibits purine nucleoside phosphorylase (PNP), a human enzyme believed to be involved in the proliferation of T cells.
"We are disappointed, but the ointment results, for most of our analysts and stockholders, were not a surprise, given the results from the Phase III last fall," said John Uhrin, vice president for corporate development at the Birmingham, Ala.-based company.
Development of the small molecule-based product has been suspended, although an oral version of the compound is progressing through Phase I and Phase I/II trials.
The 24-patient Phase II cream trial's primary endpoints consisted of quantitative scores comparing target skin lesions on the right and left sides of the body, which were treated respectively with either BCX-34 or placebo ointment. In addition, a global assessment of overall response during the eight-week course of treatment was done. The product did not achieve statistically significant improvement versus placebo by either measure.
Results from trials of the oral formulation, which is undergoing testing for HIV, along with psoriasis and cutaneous T-cell lymphoma, are expected this summer.
PNP Inhibitor Program No Longer Centerpiece
The PNP-inhibitor program from which BCX-34 emerged is still active but is no longer BioCryst's centerpiece, according to Uhrin. Instead, the company is focusing more on complement inhibitors and neuraminidase inhibitors.
The complement-inhibitor program has generated a clinical stage product for cardio-bypass surgery, BCX-1470, a serine protease inhibitor now in a Phase I study expected to conclude this summer.
At the earlier end of the pipeline, a preclinical-stage flu program centered on inhibitors of the neuraminidase enzyme is attracting attention from potential big pharma partners, with a deal likely by the end of the year.
"We've had the good fortune to bring up three projects," said Uhrin, "and for a company our size that's quite an accomplishment."
To fund this slate of research and development, BioCryst had, as of March 31, $22.4 million in cash, cash equivalents and investments, following a first-quarter net loss of $3.0 million.
The company's shares (NASDAQ:BCRX) closed Wednesday at $7.75, down $0.813. *