Galidesivir Stops Zika Viral Replication in Primate Model
June 10 2020 - 2:00PM
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced new
data published in Science Translational Medicine show, in a primate
model, that galidesivir was safe, provided post-exposure prevention
of Zika viral replication across a range of doses, and rapidly
reduced viral loads to undetectable levels when dosed up to 72
hours after infection with Zika virus.
“Galidesivir reduced Zika virus replication from
the first dose administered without impairing the adaptive immune
response that protects against subsequent infection. These data
provide an encouraging foundation for studying SARS-CoV-2, another
RNA-replicating virus, in this same animal species,” said James B.
Whitney, Ph.D., assistant professor of medicine at Harvard Medical
School and lead author of the study.
“The rapid reduction in Zika viral load we see
in this robust animal model further demonstrates the broad
antiviral potential of galidesivir against multiple pathogens. The
current COVID-19 pandemic has reinforced the urgent global need for
effective broad-spectrum antiviral therapies to combat these
outbreaks,” said Dr. William Sheridan, chief medical officer of
BioCryst.
Galidesivir is an investigational broad-spectrum
antiviral drug that was safe and well tolerated in previously
reported Phase 1 trials in healthy subjects. Galidesivir has
demonstrated broad-spectrum activity in vitro against more than 20
RNA viruses in nine different families, including the coronaviruses
that cause MERS and SARS. A Phase 1 trial to assess the safety,
clinical impact and antiviral effects of galidesivir in patients
with COVID-19 is currently enrolling patients across multiple sites
in Brazil.
Zika Study DetailsIn the Zika
virus study of galidesivir, 70 Rhesus macaques were studied with
different routes of infection, different doses of galidesivir, and
galidesivir treatment initiated at different time points after
infection. Endpoints included Zika virus RNA quantity in
plasma, saliva, urine, and cerebrospinal fluid (CSF), and a variety
of immunologic measurements, including antibody seroconversion to
Zika virus. Galidesivir was safe and showed robust antiviral
activity at all stages of Zika infection and at multiple different
doses. Zika-infected animals that were treated with
galidesivir developed an immune response to Zika that was
protective against subsequent Zika re-challenge.
About Galidesivir
(BCX4430)Galidesivir, a broad-spectrum antiviral drug, is
an adenosine nucleoside analog that acts to block viral RNA
polymerase. It is in advanced development for the treatment of
COVID-19, 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. In animal studies, galidesivir has
demonstrated activity 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 coronaviruses, filoviruses, togaviruses, bunyaviruses,
arenaviruses, paramyxoviruses, 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 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, performance 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 and manufacturing any
product candidate, including galidesivir, may take longer or may be
more expensive than planned; that funding for the continued
development and manufacture of galidesivir may not be available;
that ongoing and future preclinical and clinical studies with
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, including galidesivir; that BioCryst
may not advance human clinical trials with product candidates,
including galidesivir, as expected; that the FDA, EMA, PMDA,
ANVISA, CONEP or other applicable regulatory or ethics agency
decisions may be negatively impacted by the COVID-19 pandemic; that
such agencies 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
7910jbluth@biocryst.com
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