Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutics that have the
potential to transform radiotherapy in cancer, today announced the
first patient has been dosed in a pilot Phase 2 clinical trial of
lead product candidate avasopasem manganese (GC4419) to evaluate
its ability to improve 28-day mortality in hospitalized patients
who are critically ill with COVID-19. GC4419 is an investigational,
highly selective small molecule superoxide dismutase (SOD) mimetic
designed to rapidly and selectively convert superoxide to hydrogen
peroxide and oxygen.
“The unprecedented medical need of this pandemic has prompted
many companies in our industry to test the potential utility of
their technology to help fight this infection,” said Mel Sorensen,
M.D., President and CEO of Galera. “Our corporate mission continues
to be that of transforming radiotherapy, and we remain focused on
progressing our ongoing trials, most notably, our Phase 3 ROMAN
trial for the reduction of radiation-induced severe oral mucositis
in patients with head and neck cancer, as well as our Phase 2
anti-cancer trial in locally advanced pancreatic cancer in
combination with stereotactic body radiation therapy. We look
forward to exploring the potential of GC4419 in patients who are
critically ill with COVID-19 while maintaining a disciplined
approach to our resource allocation in support of this trial.”
The randomized, double-blind, placebo-controlled Phase 2 trial
is designed to assess the safety and efficacy of GC4419 in
improving 28-day mortality, compared to placebo. The trial will
enroll up to 50 hospitalized adult patients critically ill with
COVID-19 at several sites across the U.S. Patients in the trial
will receive 90 mg of GC4419 or placebo by infusion twice daily for
seven days. The trial will also collect additional data related to
the requirement for intensive care, mechanical ventilation, and
organ function.
“Superoxide is reported in internal and published data to play a
causative role in the progression of the hyperinflammatory phase of
this infection, sometimes referred to as cytokine storm. Galera’s
dismutase mimetics have shown the ability in preclinical models to
protect the lungs and other organs from damage caused by excessive
and prolonged superoxide production,” said Dennis Riley, Ph.D.,
Chief Scientific Officer of Galera. “Based upon the guidance of
experts in pulmonary disease and viral infections, we have worked
with the FDA to initiate this trial having recognized the
importance of potentially contributing to the care of those
affected by COVID-19.”
Multiple preclinical models suggest that by removing superoxide,
GC4419 can potentially break the hyperinflammatory cycle, and
reduce acute inflammatory lung injury and acute respiratory
distress syndrome (ARDS). In preclinical models, GC4419 has shown
it can prevent superoxide damage to the lungs by radiation therapy
and other injuries. Other preclinical models also suggest that
removing superoxide to inhibit the hyperinflammatory cycle might
reduce COVID-19 damage to other organs and the related
hypotension.
For additional information about the trial, visit
www.galeratx.com.
About GC4419 (Avasopasem Manganese)
Galera’s lead product candidate, avasopasem manganese, is an
investigational, highly selective small molecule superoxide
dismutase (SOD) mimetic that is initially being developed for the
reduction of radiation-induced severe oral mucositis (SOM), which
is not yet approved. Avasopasem is designed to rapidly and
selectively convert superoxide to hydrogen peroxide and oxygen,
protecting normal tissue from damage associated with radiation
therapy. Left untreated, elevated superoxide can damage
noncancerous tissues and lead to debilitating side effects,
including oral mucositis (OM), which can limit the anti-tumor
efficacy of radiation therapy.
Avasopasem is currently being studied in the ROMAN trial, a
randomized, double blind, placebo-controlled Phase 3 trial of
approximately 450 patients (NCT03689712, available
at clinicaltrials.gov) to investigate the effects of
avasopasem on radiation-induced OM in patients with locally
advanced head and neck cancer. In Galera’s 223-patient,
double-blind, randomized, placebo-controlled Phase 2b trial in
patients with locally advanced head and neck cancer receiving
concurrent radiation therapy, avasopasem produced a statistically
significant reduction in duration of severe oral mucositis (SOM)
from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm.
Avasopasem also demonstrated clinically meaningful reductions in
SOM incidence through completion of radiation by 34 percent and in
the severity of OM (incidence of Grade 4 OM) by 47 percent in the
90 mg treatment arm. The overall adverse event profile of
avasopasem in the Phase 2b trial was similar to that of placebo and
consistent with the known adverse effects of chemoradiation, with
reductions of blood cell counts, particularly low lymphocyte
counts, the most prominent adverse effects. Adverse events
considered attributable to avasopasem were limited to mild,
transient postural light-headedness or decreased blood pressure.
Patients were followed for two years after enrollment and showed no
difference in tumor outcomes between active and control, consistent
with expectations for combinations with intensity-modulated
radiation therapy (IMRT)/cisplatin, suggesting that the efficacy of
the chemoradiation therapy was not compromised.
Avasopasem is also currently being studied in a Phase 2a trial
for its potential to reduce the incidence of radiation-induced
esophagitis in patients with lung cancer (NCT04225026, available
at clinicaltrials.gov) and in a Phase 2 trial in hospitalized
patients who are critically ill with COVID-19; and avasopasem
completed enrollment in a pilot Phase 1/2 trial (NCT03340974,
available at clinicaltrials.gov) in combination with
stereotactic body radiation therapy (SBRT) in patients with locally
advanced pancreatic cancer.
The U.S. Food and Drug Administration granted Fast
Track and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing a pipeline of
novel, proprietary therapeutics that have the potential to
transform radiotherapy in cancer. Galera’s lead product candidate
is avasopasem manganese (GC4419), a highly selective small molecule
superoxide dismutase (SOD) mimetic initially being developed for
the reduction of radiation-induced severe oral mucositis (SOM).
Avasopasem is being studied in the Phase 3 ROMAN trial for its
ability to reduce the incidence and severity of SOM induced by
radiotherapy in patients with locally advanced head and neck cancer
(HNC), its lead indication. It is also being studied in a Phase 2a
multi-center trial in Europe assessing the safety of avasopasem in
patients with HNC undergoing standard-of-care radiotherapy, a Phase
2a trial for its ability to reduce the incidence of esophagitis
induced by radiotherapy in patients with lung cancer, and a Phase 2
trial in hospitalized patients who are critically ill with
COVID-19; and avasopasem completed enrollment in a pilot Phase 1/2
trial in combination with stereotactic body radiation therapy
(SBRT) in patients with locally advanced pancreatic cancer. The FDA
granted Fast Track and Breakthrough Therapy designations to
avasopasem for the reduction of SOM induced by radiotherapy. Galera
is headquartered in Malvern, PA. For more information, please
visit www.galeratx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding the potential,
efficacy, and regulatory and clinical development of Galera’s
product candidates, including with respect to the Phase 2 clinical
trial of avasopasem manganese (GC4419) for COVID-19. These
forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause Galera’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, including, but not limited to, the
following: Galera’s limited operating history; anticipating
continued losses for the foreseeable future; needing substantial
funding and the ability to raise capital; Galera’s dependence on
avasopasem manganese (GC4419); uncertainties inherent in the
conduct of clinical trials; difficulties or delays enrolling
patients in clinical trials; the FDA’s acceptance of data from
clinical trials outside the United States; undesirable side effects
from Galera’s product candidates; risks relating to the regulatory
approval process; failure to capitalize on more profitable product
candidates or indications; ability to receive Breakthrough Therapy
Designation or Fast Track Designation for product candidates;
failure to obtain regulatory approval of product candidates in the
United States or other jurisdictions; ongoing regulatory
obligations and continued regulatory review; risks related to
commercialization; risks related to competition; ability to retain
key employees and manage growth; risks related to intellectual
property; inability to maintain collaborations or the failure of
these collaborations; Galera’s reliance on third parties; the
possibility of system failures or security breaches; liability
related to the privacy of health information obtained from clinical
trials and product liability lawsuits; unfavorable pricing
regulations, third-party reimbursement practices or healthcare
reform initiatives; environmental, health and safety laws and
regulations; the impact of the COVID-19 pandemic on Galera’s
business and operations, including preclinical studies and clinical
trials, and general economic conditions; risks related to ownership
of Galera’s common stock; and significant costs as a result of
operating as a public company. These and other important factors
discussed under the caption “Risk Factors” in Galera’s Quarterly
Report on Form 10-Q for the quarterly period ended June 30, 2020
filed with the U.S. Securities and Exchange Commission (SEC),
Annual Report on Form 10-K for the year ended December 31, 2019 and
Galera’s other filings with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to Galera as of the date of this
release, and Galera assumes no obligation to, and does not intend
to, update any forward-looking statements, whether as a result of
new information, future events or otherwise.
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Heather Anderson6
Degrees919-827-5539handerson@6degreespr.com
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