BioCryst Completes Phase 1 Clinical Trial of Galidesivir
May 09 2019 - 4:15PM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the
completion of a randomized, placebo-controlled Phase 1 clinical
trial to evaluate intravenous (IV) galidesivir in healthy
volunteers. In the trial, galidesivir was generally safe and
well tolerated.
This placebo-controlled trial evaluated the
safety, tolerability and pharmacokinetics of escalating doses of
galidesivir in four single-dose cohorts of 5mg/kg, 10 mg/kg, 15
mg/kg and 20 mg/kg, with a total of 24 volunteers receiving
galidesivir by IV infusion. Drug exposures (Cmax and AUC) at the
highest dose were 20,500 ng/mL and 44,600 hr.ng/mL, similar to
or greater than drug exposures needed in nonclinical galidesivir
treatment experiments in Marburg virus disease and Yellow
Fever.
“These results for the IV route of
administration of galidesivir, which build on a previous successful
Phase 1 trial for the IM route, support its continued development
for serious and life-threatening infections from RNA viruses. We
appreciate the government’s continued financial support for and
collaboration on the program as we advance galidesivir into a trial
in patients with Yellow Fever in Brazil during the upcoming Yellow
Fever season,” said Dr. William Sheridan, chief medical officer of
BioCryst.
Yellow Fever is a serious infectious disease,
endemic to tropical areas of Africa and Central and South America,
and responsible for up to 170,000 severe cases and up to 60,000
deaths annually, according to the World Health Organization.
There is no approved treatment for Yellow Fever and immunization
has been hampered by global Yellow Fever vaccine shortages.
In September 2018, BioCryst announced that the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health, had awarded BioCryst an
additional $3.5 million to support clinical trials of galidesivir
in patients with Yellow Fever.
The galidesivir development program is
substantially funded with federal funds from NIAID and by the
Biomedical Advanced Research and Development Authority
(BARDA).
BioCryst has global rights to galidesivir, a
broad-spectrum antiviral drug in development to treat Marburg virus
disease and Yellow Fever. In a previous Phase 1 trial of clinical
safety and pharmacokinetics in healthy subjects, intramuscularly
(IM) administered galidesivir was safe and well tolerated. In
animal studies, galidesivir also has demonstrated survival benefits
against several serious viral infections including Ebola, Marburg,
Yellow Fever and Zika.
Since September 2013, NIAID has supported
BioCryst in developing galidesivir as a therapeutic for Ebola and
Marburg viruses under Contract No. HHSN272201300017C. The NIAID
development contract totals $43.0 million.
Since March 2015, BARDA has supported the
galidesivir development program under contract HHSO100201500007C
for the continued development of galidesivir as a potential
treatment for filoviruses. The total BARDA contract
value to advance the program through toxicology studies and
manufacturing work to support a new drug application is $39.1
million if all contract options are exercised.
About Galidesivir
(BCX4430)Galidesivir is a broad-spectrum antiviral in
advanced development for the treatment Marburg virus disease and
Yellow Fever. Phase 1 clinical safety and pharmacokinetics trials
of galidesivir by both intravenous and intramuscular routes of
administration in healthy subjects have been completed and, in
animal studies, galidesivir has demonstrated survival benefits
against a variety of serious pathogens, including Ebola, Marburg,
Yellow Fever and Zika viruses. Galidesivir has also demonstrated
broad-spectrum activity in vitro against more than 20 RNA viruses
in nine different families, including filoviruses, togaviruses,
bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and
flaviviruses. BioCryst is developing galidesivir in collaboration
with U.S. government agencies and other institutions.
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 a
preclinical program to develop oral ALK-2 inhibitors 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
BioCryst or its licensees may not be able to enroll the required
number of subjects in planned clinical trials of galidesivir and
that such clinical trials may not be successfully completed; that
the Company or its licensees may not commence additional
pre-clinical studies or human clinical trials may not be commenced
as expected; that the FDA may require additional studies beyond
those planned for galidesivir, or may not provide regulatory
clearances which may result in delay of planned clinical trials, or
may impose a clinical hold on galidesivir, or withhold market
approval for product candidates; that the Company may not be able
to obtain additional funding for galidesivir; that government
funding or other contracts for galidesivir may have certain terms
and conditions, including termination provisions, that subject the
Company to additional risks; that the Company may lose current
funding for the program; that its actual financial results may not
be consistent with its expectations, including that 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
7910jbluth@biocryst.com
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