BioCryst to Present New Berotralstat Data at European Academy of Allergy and Clinical Immunology Digital Congress

Rhea-AI Summary

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced it will present new data on berotralstat (BCX7353), an oral therapy for hereditary angioedema (HAE), at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) digital congress from June 6-8. Key data include findings from the APeX-S and APeX-2 studies, showcasing berotralstat's long-term safety and significant reduction in HAE attacks. As regulatory approvals approach in the U.S., Japan, and EU, Dr. William Sheridan emphasized berotralstat's potential impact on HAE patients.

RESEARCH TRIANGLE PARK, N.C., May 26, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company will present new data on berotralstat (BCX7353), an oral, once-daily therapy under regulatory review in the United States, Japan and the European Union for the prevention of hereditary angioedema (HAE) attacks, at the upcoming digital congress of the European Academy of Allergy and Clinical Immunology (EAACI) June 6-8.  EAACI plans to make content from the congress available at 9:00a CET on June 6.

• Long-Term Safety and Tolerability of Berotralstat (BCX7353) for Hereditary Angioedema (HAE) Prophylaxis: APeX-S Study Results; oral abstract session 21 (#484)
   
• Berotralstat (BCX7353) Treatment Demonstrates Robust and Durable Reduction in the Rate of Hereditary Angioedema (HAE) Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; poster discussion session 06 (#1406)
   
• Berotralstat (BCX7353) Treatment Following 24-Weeks of Placebo Results in Rapid and Sustained Reduction in the Rate of Hereditary Angioedema (HAE) Attacks: APeX-2 Study Results; thematic poster session 07 (#1219)
   
• Berotralstat (BCX7353) Treatment Demonstrates Robust and Durable Reduction in the Rate of Hereditary Angioedema (HAE) Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; thematic poster session 07 (#1241)
   
• Hereditary Angioedema Patients in the United States Report Expanded Use of Prophylaxis, but Continue to Experience Attacks; thematic poster session 07 (#196)

“As berotralstat gets closer to potential approval in Japan and the U.S. later this year, and the EU early next year, it is exciting to share additional data highlighting the meaningful impact an oral, once-daily medicine is having for HAE patients in our clinical program,” said Dr. William Sheridan, chief medical officer of BioCryst.  

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 berotralstat (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 COVID-19, 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.

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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners’ development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; 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 galidesivir 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 BioCryst 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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.

BCRXW

Contact:
John Bluth
+1 919 859 7910
jbluth@biocryst.com

FAQ

What new data will BioCryst present at the EAACI congress regarding BCRX?

BioCryst will present data on berotralstat (BCX7353), focusing on its long-term safety, efficacy, and impact on HAE attacks.

When will BioCryst present its findings at the EAACI congress?

The findings will be presented during the EAACI digital congress from June 6-8, 2020.

What is berotralstat's significance for hereditary angioedema patients?

Berotralstat is an oral therapy that shows a robust reduction in HAE attacks, offering a new treatment option for patients.

What are the upcoming regulatory timelines for BCRX's berotralstat?

Berotralstat is under regulatory review in the U.S. and Japan for potential approval later this year and in the EU early next year.

Which studies will be highlighted in the presentation about berotralstat?

Key studies include the APeX-S study and results from the APeX-2 study, demonstrating the drug's effectiveness in reducing HAE attacks.