BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that
the National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health, has awarded BioCryst a
new contract (75N93020C00055) totaling $44 million, and has added
approximately $3 million to its existing contract
(HHSN272201300017C), to support the development of
galidesivir.
The additional funds under these
performance-based contracts support:
- The completion of parts 1 and 2 of an ongoing clinical trial of
galidesivir in Brazil
- Conducting a phase 2 clinical trial of galidesivir in
non-hospitalized COVID-19 patients at high risk for developing
severe disease and complications of COVID-19
- Conducting a clinical pharmacology trial of galidesivir to
determine appropriate dosing in patients with renal impairment
- Increasing the supply of galidesivir
“With this additional investment in galidesivir
by NIAID, we are now positioned to further evaluate and advance
galidesivir through additional clinical trials in different
settings beyond hospitalized patients, and to accelerate our
manufacturing activities to increase drug supply,” said Jon
Stonehouse, chief executive officer of BioCryst.
“We appreciate the financial investment the
government continues to make in the galidesivir program. We believe
broad-spectrum antivirals, like galidesivir, are critical to combat
both the current COVID-19 pandemic and threats from future
viruses,” Stonehouse added.
Galidesivir is an investigational broad-spectrum
antiviral drug that was safe and well tolerated in previous 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.
The review of unblinded data from part 1 of an
ongoing phase 1 trial (NCT03891420) to assess the safety (primary
endpoint), clinical impact and antiviral effects of galidesivir in
patients with COVID-19, and a decision to choose a dose and advance
into part 2 of the trial, are expected to occur in the fourth
quarter of 2020.
Additionally, non-human primate studies and
supporting in vitro studies are underway to assess the activity of
galidesivir against SARS-CoV-2, the virus that causes COVID-19.
The galidesivir development program is
substantially funded with federal funds from NIAID and by
Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response in the U.S. Department of Health and Human Services. Since
September 2013, NIAID has supported BioCryst in developing
galidesivir as broad-spectrum antiviral therapeutic 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 broad-
spectrum antiviral treatment for filoviruses. In addition to the
new contract award from NIAID, there is currently approximately $27
million remaining on the existing BARDA contract.
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.
Part 1 of an ongoing phase 1 trial (NCT03891420)
to assess the safety (primary endpoint), clinical impact and
antiviral effects of galidesivir in patients with COVID-19 is
currently enrolling 24 hospitalized adults diagnosed with moderate
to severe COVID-19 confirmed by PCR. In part 1, three cohorts of
eight patients are randomized to receive intravenous (IV)
galidesivir (n=6) or placebo (n=2) every 12 hours for seven 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. 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.
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 ORLADEYO™ (berotralstat), 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
BioCryst’s plans and expectations for its galidesivir development
program. These statements involve known and unknown risks,
uncertainties and other factors which may cause actual results and
developments of such program to be materially different from any
future results or developments expressed or implied by the
forward-looking statements. These statements reflect our current
views 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: NIAID’s ability to determine not to exercise its
options under the new contract or to terminate the contract at any
time, causing BioCryst not to realize the aggregate value of the
contract; funding for galidesivir under government contracts is
dependent on the progress toward, and the achievement of,
developmental milestones; the ongoing COVID-19 pandemic could
create challenges in all aspects of BioCryst’s business, including
without limitation delays, stoppages, difficulties and increased
expenses with respect to BioCryst’s and its partners’ development,
regulatory processes and supply chains, negatively impact
BioCryst’s ability to access the capital or credit markets to
finance its operations, or have the effect of heightening many of
the risks described herein or in the documents BioCryst files
periodically with the Securities and Exchange Commission;
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; BioCryst may not be able to enroll the required
number of subjects in planned clinical trials of product
candidates, including galidesivir; BioCryst may not advance human
clinical trials with product candidates, including galidesivir, as
expected; and the FDA, or other applicable regulatory agency may
require additional studies beyond the studies planned for product
candidates, may not provide regulatory clearances which may result
in delay of planned clinical trials, may impose a clinical hold
with respect to such product candidates, or may withhold market
approval for 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
Contact:John Bluth+1 919 859
7910jbluth@biocryst.com
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