BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that
the company has opened enrollment into a randomized, double-blind,
placebo-controlled clinical trial to assess the safety, clinical
impact and antiviral effects of galidesivir in patients with
COVID-19. The trial (NCT03891420) is being funded by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health.
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.
In the COVID-19 trial, efficacy measures include
time to clinical improvement, time to hospital discharge, time to
undetectable levels (as measured by polymerase chain reaction (PCR)
in respiratory specimens) of SARS-CoV-2, the virus that causes
COVID-19, and all-cause mortality.
The trial will be conducted in Brazil under a
U.S. investigational new drug application, and the protocol also
has been approved by the Agência Nacional de Vigilância Sanitária
(ANVISA) and the Brazilian National Ethics Committee (CONEP).
“Galidesivir has been safe and well-tolerated in
Phase 1 studies, and, as a potent broad-spectrum antiviral
medicine, we are hopeful that we will see a benefit in patients
with COVID-19. This trial is part of the scientific community’s
effort to urgently find effective treatments for patients in this
global health emergency,” said Dr. William Sheridan, chief medical
officer of BioCryst.
“We have begun to see COVID-19 cases in Brazil,
and we have a good opportunity to enroll and treat patients earlier
in their disease course to determine if galidesivir can benefit
patients with COVID-19,” said Dr. Esper Kallas, infectious diseases
specialist and professor of medicine at the School of Medicine,
University of São Paulo, and principal investigator of the COVID-19
clinical trial with galidesivir.
Galidesivir COVID-19 Trial
Design Part 1 of the trial will enroll 24 hospitalized
adults diagnosed with moderate to severe COVID-19 confirmed by PCR.
Three cohorts of eight patients will be randomized to receive
intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours
for 7 days. Upon completion of part 1 of the trial, an optimized
dosing regimen of galidesivir will be selected for part 2 of the
trial, based on part 1 results including safety, viral load
reduction in respiratory tract secretions, improvement in COVID-19
signs and symptoms and clinical manifestations, and mortality. In
part 2 of the trial, up to 42 hospitalized patients with COVID-19
will be randomized 2:1 to receive IV galidesivir or placebo. After
treatment, the patients will remain hospitalized until resolution
of COVID-19 symptoms allows release. All patients will be followed
for mortality through Day 56.
The galidesivir development program is
substantially funded with federal funds from NIAID and by the
Biomedical Advanced Research and Development Authority
(BARDA). Since September 2013, NIAID has supported BioCryst
in developing galidesivir as a therapeutic for Ebola and Marburg
viruses under contract HHSN272201300017C. 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.
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 StatementsThis 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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