Full target enrollment of 216 patients
achieved
Topline data from CARPO expected in 2Q
2024
LA JOLLA, Calif.,
April 24,
2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica")
(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 last patient has
been enrolled in its Phase 2b CARPO
trial of Auxora™ in acute pancreatitis (AP). 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.
"We are very grateful to the patients and families that have put
their trust in us throughout this enrollment process," said
Rachel Leheny, Ph.D., Chief
Executive Officer of CalciMedica. "We are a significant step closer
to delivering a potential treatment for acute pancreatitis, for
which there is currently no approved therapy. We look forward to
sharing the results of this clinical trial in the coming weeks once
the last patient has finished treatment and the data have been
analyzed."
CARPO is an international, randomized, double-blind,
placebo-controlled, dose-ranging trial intended to establish
Auxora's dose-response and efficacy in AP with accompanying
systemic inflammatory response syndrome (SIRS). The trial reached
its target enrollment of 216. These patients have been randomized
into four groups to receive either 2.0 mg/kg, 1.0 mg/kg or 0.5
mg/kg of Auxora or a dose of placebo intravenously every 24 hours
for a total of three doses. CARPO protocol requires that treatment
and observation of patients continue for 30 days, and the company
plans to report topline data later this quarter.
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, expected to initiate in the second quarter
of 2024 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 AP
AP, or inflammation of the pancreas, can be a life-threatening
condition. Moderate or severe AP sometimes leads to pancreatic cell
death or necrosis, systemic inflammation, organ failure and death.
There are an estimated 275,000 hospitalizations for AP annually in
the United States, of which
approximately 40% present with SIRS, a predictor of moderate and
severe disease which can compromise the function of other tissues
or organs, especially the lungs. Organ failure is responsible for
much of the mortality seen in AP. There is currently no approved
therapy for AP. Details of the CARPO trial are available on
clinicaltrials.gov (NCT04681066).
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™, a proprietary, intravenous-formulated CRAC channel
inhibitor, has demonstrated positive and consistent clinical
results in multiple completed efficacy clinical trials. CalciMedica
is currently conducting a Phase 2b
trial (called CARPO – NCT04681066) for AP with SIRS, with topline
data expected in the second quarter of 2024, as well as supporting
the ongoing Phase 1/2 AIPT study (called CRSPA – NCT04195347), with
data expected in 2025. CalciMedica plans to initiate its Phase 2
study (called KOURAGE – NCT06374797) in AKI with associated AHRF in
the second quarter of 2024 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
thereof and the expected timing for the release of data from those
trials, including its Phase 2b CARPO
trial of Auxora for AP with accompanying SIRS, its planned Phase 2
KOURAGE trial of Auxora in AKI with associated AHRF, and its
ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with
AIPT; the potential benefits of Auxora for the treatment of AP, AKI
and AIPT; the estimated patient populations in the United States for AP; 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 Annual Report on Form 10-K for the year
ended December 31, 2023, 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.