Press Release Details

RESEARCH TRIANGLE PARK, N.C., May 29, 2018 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced the presentation of additional analyses of the APeX-1 trial of BCX7353 for the prevention of attacks in patients with Hereditary Angioedema (“HAE”) at the annual congress of the European Academy of Allergy and Clinical Immunology (“EAACI”), being held May 26-30, 2018 in Munich, Germany. Researchers are presenting 4 abstracts in poster sessions on May 27th and May 29th:

Abstract Title:  Prophylactic Therapy with BCX7353 Reduces Anxiety and Stress in Hereditary Angioedema with C1-INH-HAE Subjects: Data from the Phase 2 APeX-1 Trial
Presenter: Dr. Markus Magerl

Abstract Title: Analysis of Gastrointestinal Symptoms in Subjects with C1-INH deficiency HAE treated with BCX7353:  Results from the Phase 2 APeX-1 Trial. 
Presenter: Dr.  Emel Aygören-Pürsün

Abstract Title: Pharmacokinetic and Pharmacodynamic effects of BCX7353 in Subjects with C1-INH-HAE:   Results from the Phase 2 APeX-1 Trial.
Presenter:  Dr. Vesna Grivcheva-Panovska

Abstract Title: BCX7353 Improves Health-Related Quality of Life in Hereditary Angioedema with C1-inhibitor deficiency (C1-INH-HAE):  Findings from the Phase 2 APeX-1 Trial
Presenter:  Dr. Markus Magerl

“These additional analyses of our Phase 2 APeX-1 trial of once-daily oral BCX7353 provide further details regarding pharmacokinetics, safety, and effects on target enzyme (plasma kallikrein) inhibition as well as measures of quality of life and symptoms of stress, anxiety and depression in patients with hereditary angioedema,” said Dr. William Sheridan, SVP and Chief Medical Officer of BioCryst Pharmaceuticals. “The APeX-1 trial results formed the basis of our ongoing double-blind randomized Phase 3 trial, APeX-2, comparing 2 dose levels of daily BCX7353 to placebo. We remain on track to report the results of APeX-2 in the first half of 2019.”

Copies of the posters are available on the company’s website: www.biocryst.com.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and a preclinical program to develop oral Alk-2 inhibitors for the treatment of fibrodysplasia ossificans progressive (“FOP”). 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.

Forward-Looking Statements

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 HAE second generation drug candidates (including ZENITH-1, APeX-2 and APeX-S) 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 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. 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.

BCRXW

CONTACT:    Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910

Source: BioCryst Pharmaceuticals, Inc.