Development of Auxora in AKI is supported by
both clinical and pre-clinical evidence
Topline data expected in 2025
LA
JOLLA, Calif., July 9, 2024
/PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the
"Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical
company focused on developing novel calcium release-activated
calcium (CRAC) channel inhibition therapies for acute and chronic
inflammatory and immunologic illnesses, today announced that the
first patient has been dosed in KOURAGE, the Company's Phase 2
trial evaluating Auxora™ for the treatment of severe acute kidney
injury (AKI) with associated acute hypoxemic respiratory failure
(AHRF).
"AKI is a serious condition, causing about 3.7 million
hospitalizations annually just in the
United States," said Lakhmir
Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, Chief Medical
Officer at ExThera Medical, and Chair of the KOURAGE Steering
Committee. "Disease progression for patients with AKI can occur
quickly, and those who reach Stage 2 and Stage 3 AKI face
significant risk of mortality and serious morbidities such as
respiratory failure. The current standard of care for these
patients is limited to supportive therapy. With Auxora, CalciMedica
continues to lay the foundation for a potentially revolutionary
treatment for an underserved and often fatal disease."
"Auxora has shown promising data in preclinical models and prior
human trials which highlight its potential as a therapeutic option
for AKI, where none currently exists," said Glenn Chertow, M.D., Norman S. Coplon/ Satellite Healthcare Professor
of Medicine, Professor of Epidemiology and Population Health and
Health Policy at Stanford Medicine, and Member of the KOURAGE
Steering Committee. "In KOURAGE, Auxora will be used to treat
patients with established, moderate to severe AKI, and I look
forward to reviewing the data in the coming year."
KOURAGE is a randomized, double-blind, placebo-controlled study
expected to enroll approximately 150 patients with Stage 2 and 3
AKI who have AHRF and will randomize patients to receive 5 daily
doses of Auxora or placebo. The study will assess patients up to
day 30 following the final dosing to evaluate the number of days
alive without the need for a ventilator or dialysis. The study's
secondary endpoints will include a composite measure of all-cause
mortality, decline in estimated glomerular filtration rate (eGFR)
and the occurrence of dialysis over a 90-day period, also known as
MAKE-90 (Major Adverse Kidney Events at 90 days). Topline data from
KOURAGE are expected in 2025.
"Our CARDEA trial revealed that treatment of severe and critical
COVID-19 pneumonia patients with Auxora reduced the reported
incidence of AKI and improved the survival of patients with kidney
disease," said Sudarshan Hebbar,
M.D., Chief Medical Officer of CalciMedica. "We demonstrated the
potential benefits of Auxora in an ischemia reperfusion model of
AKI that showed that the therapeutic treatment of AKI with Auxora
improved kidney function as measured by estimated glomerular
filtration rate and enhanced survival. These results were presented
at the 29th International Conference on Advances in
Critical Care Nephrology that was held in March of this year. These
data contribute to the growing body of evidence supporting Auxora
as a potential treatment for various acute and critical
illnesses."
About Auxora™
CalciMedica's lead clinical
compound, Auxora™, is a potent and selective small molecule
inhibitor of Orai1-containing CRAC channels that is being developed
for use in patients with acute inflammatory and immunologic
illnesses. CRAC channels are found on many cell types, including
immune system cells, endothelium cells and pancreatic acinar cells,
where aberrant activation of these channels may play a key role in
the pathobiology of acute and chronic inflammatory syndromes.
Auxora is currently being evaluated in: (i) a Phase 2b trial for acute pancreatitis (AP) with
accompanying systemic inflammatory response syndrome (SIRS), called
CARPO, (ii) a Phase 2 trial in acute kidney injury (AKI) with
associated acute hypoxemic respiratory failure (AHRF), called
KOURAGE, and (iii) an investigator-sponsored Phase 1/2 trial,
called CRSPA, being conducted in pediatric patients with
asparaginase-induced pancreatic toxicity (AIPT) as a side effect of
pediatric acute lymphoblastic leukemia treatment with asparaginase.
There are currently no approved therapies to treat either AP, AKI
or AIPT. In previous trials, patients responded well to Auxora
regardless of severity or cause of
disease. CalciMedica is also exploring the potential of
Auxora treatment for other acute indications including acute
respiratory distress syndrome.
About KOURAGE and AKI
KOURAGE is a randomized, double-blind, placebo-controlled study
that will evaluate 150 patients with Stage 2 and 3 AKI who have
AHRF and are receiving oxygen by non-invasive mechanical
ventilation, high flow nasal cannula or intermittent mandatory
ventilation (IMV). AKI denotes a sudden reduction in kidney
function, the organ's ability to clean and filter the blood. AKI
can result as a complication of other serious illnesses such as
sepsis, respiratory infections and failure, acute pancreatitis,
trauma, surgery and burns. There are approximately 3.7 million
patients hospitalized with AKI in the
United States each year with approximately 1.1 million
advancing to Stage 2 and Stage 3 AKI, over half of whom have
associated AHRF. The risk of serious morbidities and mortality is
significant for advanced Stage 2 and Stage 3 AKI patients. There
are currently no approved therapies for AKI.
About CalciMedica
CalciMedica is a clinical-stage
biopharmaceutical company focused on developing novel CRAC channel
inhibition therapies for inflammatory and immunologic diseases.
CalciMedica's proprietary technology targets the inhibition of CRAC
channels to modulate the immune response and protect against tissue
cell injury, with the potential to provide therapeutic benefits in
life-threatening inflammatory and immunologic diseases for which
there are currently no approved therapies. CalciMedica's lead
product candidate Auxora™ has demonstrated positive and consistent
clinical results in multiple completed efficacy clinical trials.
CalciMedica has announced topline data for a Phase 2b trial (called CARPO – NCT04681066) in patients
with AP with SIRS and completed a Phase 2 trial (called CARDEA
– NCT04345614) in patients with COVID pneumonia. The
Company is currently conducting a Phase 2 trial (called KOURAGE –
NCT06374797) in patients with AKI with associated AHRF with data
expected in 2025 and continuing to support the ongoing Phase 1/2
trial (called CRSPA – NCT04195347) in patients with AIPT with data
expected in 2025. CalciMedica was founded by scientists from Torrey
Pines Therapeutics and the Harvard CBR Institute for Biomedical
Research, and is headquartered in La
Jolla, CA. For more information, please visit
www.calcimedica.com.
Forward-Looking Statements
This communication contains
forward-looking statements which include, but are not limited to,
CalciMedica's planned and ongoing clinical trials and the timing,
design, expected patient enrollment 6thereof and the expected
timing for the release of data from those trials, including its
Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF, its
Phase 2b CARPO trial of Auxora for AP
with accompanying SIRS, and its ongoing Phase 1/2 CRSPA trial
of Auxora in pediatric patients with AIPT; the potential benefits
of Auxora for the treatment of AKI, AP, and AIPT; the estimated
patient populations in the United
States for AKI; the potential of Auxora for the treatment of
other acute indications including acute respiratory distress
syndrome; and the potential of CalciMedica's proprietary technology
to provide therapeutic benefits in life-threatening inflammatory
and immunologic diseases. These forward-looking statements are
subject to the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. CalciMedica's expectations and
beliefs regarding these matters may not materialize. Actual
outcomes and results may differ materially from those contemplated
by these forward-looking statements as a result of uncertainties,
risks, and changes in circumstances, including but not limited to
risks and uncertainties related to: the impact of fluctuations in
global financial markets on CalciMedica's business and the actions
it may take in response thereto; CalciMedica's ability to execute
its plans and strategies; the ability to obtain and maintain
regulatory approval for Auxora; results from clinical trials or
preclinical studies may not be indicative of results that may be
observed in the future; potential safety and other complications
from Auxora; the scope, progress and expansion of developing and
commercializing Auxora; the size and growth of the market therefor
and the rate and degree of market acceptance thereof; economic,
business, competitive, and/or regulatory factors affecting the
business of CalciMedica generally; CalciMedica's ability to protect
its intellectual property position; and the impact of government
laws and regulations. Additional risks and uncertainties that could
cause actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption "Risk Factors" in CalciMedica's Quarterly Report on
Form 10-Q for the quarter ended March 31,
2024, and elsewhere in CalciMedica's subsequent reports
on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to
time and available at www.sec.gov. These documents can be accessed
on CalciMedica's web page at
ir.calcimedica.com/financials-filings/sec-filings. The
forward-looking statements contained herein are made as of the date
hereof, and CalciMedica undertakes no obligation to update them
after this date, except as required by law.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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SOURCE CalciMedica, Inc.
