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—Results of the APeX-S and APeX-2 trials show patients taking 150 mg of oral, once daily BCX7353 achieved a stable average attack rate of ≤ 1 attack per month at 48 weeks—
—75 percent of patients taking 150 mg BCX7353 completed 48 weeks of dosing in the Phase 3 APeX‑2 trial—
—Comprehensive market research from 100 HAE patients and 175 treating physicians shows strong demand for oral, once daily BCX7353—
RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced 48-week results from its APeX-S and APeX-2 trials and comprehensive market research which support the significant commercial opportunity for oral, once daily BCX7353 in HAE.
“The 48-week clinical trial data we now have from APeX-S and APeX-2 highlight the control patients are having over their attacks with oral, once daily BCX7353, and consequently why 75 percent of patients stayed on-study through 48 weeks when they had other choices,” said Jon Stonehouse, chief executive officer of BioCryst.
“Since receiving the 24-week data from APeX-2 in May, we have conducted detailed and comprehensive market research to update our understanding of the commercial potential and value of BCX7353 with patients, treating physicians and payors. It is clear from this work that, regardless of their current treatment, HAE patients are eager to use, physicians are expecting to prescribe and payors are willing to reimburse oral once a day BCX7353,” Stonehouse added.
Key Findings from 48-week APeX-S and APeX-2 Data:
Key Findings from Market Research
Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:00 a.m. ET today. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4891026. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4891026.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2019 operating expenses and cash usage may not be within management's expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.
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