BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX4161 for the Treatment of Hereditary Angioedema

Mon Mar 25, 2013 6:05am EDT

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RESEARCH TRIANGLE PARK, N.C.--(Business Wire)--
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the initiation of a
Phase 1 clinical trial to evaluate the safety, pharmacokinetics and
pharmacodynamics of orally-administered BCX4161 in healthy volunteers.
Discovered by BioCryst, BCX4161 is a novel, selective inhibitor of plasma
kallikrein in development for prevention of attacks in patients with hereditary
angioedema (HAE). 

"Daily, oral administration of a safe and efficacious prophylactic drug would
revolutionize treatment for patients suffering from this serious condition,"
said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst.
"BCX4161 has the potential to be the first oral treatment developed specifically
for the prevention of HAE attacks." 

BioCryst has successfully completed nonclinical safety studies, as well as in
vitro and in vivo studies in which BCX4161 exhibited potent and selective
inhibition of plasma kallikrein and a favorable safety profile. A poster titled
"BCX4161, A Small Molecule Orally Bioavailable Plasma Kallikrein Inhibitor, for
the Treatment of Hereditary Angioedema" was presented at the 2013 American
Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February. 

The main goals of the Phase 1 clinical trial are to assess safety, characterize
plasma drug levels, and estimate the extent of kallikrein inhibition achieved
after oral dosing of BCX4161. This clinical trial is being conducted at Quotient
Clinical in the United Kingdom utilizing an integrated Translational
PharmaceuticsTM platform and the results are expected to be announced in 2013.
If the Phase 1 program achieves its goals, BioCryst plans to initiate a Phase 2
program in HAE patients. 

About Hereditary Angioedema

HAE is a rare, severely debilitating and potentially fatal genetic condition
that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE symptoms include
recurrent episodes of edema in various locations, including the hands, feet,
face, genitalia and airway. In addition, patients often have bouts of
excruciating abdominal pain, nausea and vomiting that are caused by swelling in
the intestinal wall. Airway swelling is particularly dangerous and can lead to
death by asphyxiation. Further information regarding HAE can be found at
www.haea.org. 

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule
drugs that block key enzymes involved in infectious and inflammatory diseases,
with the goal of addressing unmet medical needs of patients and physicians.
BioCryst currently has two late-stage development programs: peramivir, a viral
neuraminidase inhibitor for the treatment of influenza, and ulodesine, a purine
nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition,
BioCryst has several early-stage programs: BCX4161 and a next generation oral
inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a broad
spectrum antiviral for hemorrhagic fevers. 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 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 BioCryst
may not be able to enroll the required number of subjects in the clinical trial
for BCX4161, that the BCX4161 trial may not have a favorable outcome or may not
be successfully completed; that the Company may not commence additional human
clinical trials for BCX4161; that the FDA or similar regulatory agency may
refuse to approve subsequent studies, may impose a clinical hold for BCX4161 or
other product candidates, or delay approval of clinical studies which may result
in a delay of planned clinical studies and increase development costs of a
product candidate; that the FDA may withhold market approval for product
candidates; that ongoing and future preclinical and clinical development may not
have positive results; that the Company or its licensees may not be able to
continue future development of current and future development programs; that
such development programs may never result in future product, license or royalty
payments being received; that the Company may not be able to retain its current
pharmaceutical and biotechnology partners for further development of its product
candidates or may not reach favorable agreements with potential pharmaceutical
and biotechnology partners for further development of 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

BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910 

Copyright Business Wire 2013