CalciMedica Announces First Patient Enrolled in International Expansion of CARPO Trial of Auxora™ in Acute Pancreatitis (AP)
09 Agosto 2023 - 8:30AM
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 its ongoing CARPO trial, a Phase 2b trial evaluating
Auxora™ for the treatment of acute pancreatitis (AP) with
accompanying systemic inflammatory response syndrome (SIRS), was
expanded to clinical research sites in India and that the first
patient has been enrolled there.
Overseeing the trial in India as a member of the steering
committee is Dr. Pramod Garg, Professor of Gastroenterology and
Associate Dean of Research at the All India Institute of Medical
Sciences in New Delhi, India.
“We are thrilled to have Dr. Garg overseeing the continuation of
our Phase 2b CARPO study in acute pancreatitis in India,” said
Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica.
“Further, we are excited that the study sites in India have
significant experience in conducting clinical trials for AP and
other critical illnesses. As we move forward with CARPO
internationally, we hope to build upon the promising data from our
Phase 2a trial of Auxora in patients with AP and accompanying SIRS
and the trials in patients with severe or critical COVID-19
pneumonia.”
CARPO is expected to enroll approximately 216 patients at more
than 30 sites in the United States and India. The randomized,
double-blind, placebo-controlled, dose-ranging trial is intended to
demonstrate the tolerability and potential efficacy of Auxora in
patients who have AP with accompanying SIRS, a condition that can
be life-threatening and for which there is currently no approved
therapy. Data from the CARPO trial are expected in the first half
of 2024.
“The expansion of CARPO to include international sites is a
meaningful achievement in our mission to help patient populations
globally whose needs are currently unmet,” said Rachel Leheny,
Ph.D., Chief Executive Officer of CalciMedica. “Auxora is a
promising therapeutic candidate that has demonstrated in previous
clinical trials its strong potential to address the underlying
pathobiology of AP and provide a much-needed therapy for these
severely ill patients. We look forward to seeing the results from
CARPO in the first half of next year.”
About Auxora™CalciMedica’s lead
clinical compound, Auxora™, is a potent and selective small
molecule inhibitor of Orai1-containing calcium release-activated
calcium (CRAC) channels that is being developed for use in patients
with inflammatory illnesses. CRAC channels are found on many cell
types, including pancreatic acinar cells, lung endothelium cells
and immune system 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) an investigator-sponsored Phase 1/2 trial called CRSPA
being conducted in pediatric patients with asparaginase-induced
pancreatic toxicity (“AIPT”) (also known as asparaginase-associated
pancreatitis) as a side effect of pediatric acute lymphoblastic
leukemia treatment with asparaginase, and (iii) a Phase 2 dose
ranging pharmacodynamic study in critical COVID-19 patients. There
are currently no approved therapies to treat either AP or AIPT. In
previous trials for both AP and COVID-19 pneumonia, patients
responded well to Auxora regardless of the severity of disease at
baseline. CalciMedica is also exploring potential Auxora treatment
for other acute indications including acute kidney injury and acute
respiratory distress syndrome.
About CARPOCARPO is an
international, randomized, double-blind, placebo-controlled,
dose-ranging trial intended to establish efficacy in acute
pancreatitis (AP). It is expected to enroll 216 patients. AP can be
a life-threatening condition where the pancreas becomes inflamed,
sometimes leading 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, 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 CalciMedicaCalciMedica 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 designed to modulate the immune
response and protect against tissue cell injury, with the potential
to provide therapeutic benefits in life-threatening inflammatory
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 four completed efficacy
clinical trials. Auxora is in development for acute pancreatitis
with systemic inflammatory response syndrome and
asparaginase-associated pancreatitis. 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 StatementsThis
communication contains forward-looking statements which include,
but are not limited to, statements regarding the potential benefits
of Auxora; and timing, design and enrollment plans of CARPO. 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 successfully execute its plans
and strategies which include conducting a significant portion of
the CARPO trial in India; risks associated with development of
novel therapeutics, including potential delays in clinical trials
and enrollment; the ability to obtain and maintain regulatory
approval for CalciMedica’s product candidates; results from
clinical trials may not be indicative of results that may be
observed in the future; potential safety and other complications
from CalciMedica’s product candidates; 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, 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.
CalciMedica Contact:
Investors and MediaArgot
Partners Sarah Sutton/Kevin
Murphycalcimedica@argotpartners.com(212) 600-1902
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