CalciMedica Announces Publication of Preclinical Data in Journal of Clinical Investigation (JCI) Insight Supporting the Development of CRAC Channel Inhibitors for Chronic Pancreatitis (CP)
June 06 2023 - 7:30AM
CalciMedica Inc. (“CalciMedica”) (OTCQB: CALC), a clinical-stage
biopharmaceutical company focused on developing therapies for
life-threatening inflammatory diseases with high unmet need, today
announced the publication of preclinical data in The Journal of
Clinical Investigation (JCI) Insight that details the potential
benefit of CRAC channel inhibitors for chronic pancreatitis (CP).
The study, titled “Orai1 calcium channel inhibition prevents
progression of chronic pancreatitis,” was conducted by József
Maléth, M.D., Ph.D., and his team at University of Szeged and the
manuscript was co-authored by CalciMedica’s co-founder and Chief
Scientific Officer, Ken Stauderman, Ph.D., and CalciMedica’s Chief
Medical Officer, Sudarshan Hebbar, M.D.
“We are encouraged by the data gathered in this
study, which illustrate the potential benefit of Orai1 inhibition
with a selective CRAC channel inhibitor for the treatment of
chronic pancreatitis,” said Dr. Stauderman. “The data show that
inhibition of Orai1 channels diminished aberrant SOCE, restored the
expression of SARAF, a protein that inhibits CRAC channels and is
decreased in pancreatitis, and prevented the progression of early
CP to end-stage disease in mice. In addition, a decrease in
fibrosis was observed in the mouse model, consistent with a
significant reduction in the severity of CP. The work that we have
done with Dr. Maléth and his team builds on previous research with
CM5480, a CRAC channel inhibitor tool compound, in acute
pancreatitis and suggests that Orai1 inhibition has implications
beyond the management of RAP and can act as a treatment for both
early and end-stage CP.”
CP is a progressive inflammatory disease
characterized by an inability of the SOCE signaling mechanism to
properly regulate Ca2+ influx, resulting in intracellular Ca2+
overload. The study authors aimed to demonstrate that Orai1
inhibition using the selective CRAC channel inhibitor, CM5480,
prevents the progression of RAP into early CP, both as simulated by
the model, and, eventually, into end-stage CP. The authors found
that the use of CM5480 to inhibit Orai1 impaired inflammatory cell
infiltration improved acinar cell enzyme activity, maintained
ductal cell secretory function and prevented activation of
pancreatic stellate cells (PSCs), in turn decreasing tissue damage
and fibrosis in CP. As a result, the progression of RAP and early
CP into established CP was prevented. These results support the
initiation of clinical studies to assess the beneficial effects of
Orai1 inhibition in patients with RAP and early CP.
"The pathogenesis of CP is complex and involves
interactions among multiple cell types. Using ex vivo and in vivo
preclinical disease models, we demonstrated that Orai1 inhibition
prevents progression of RAP and early CP,” said Dr. Maléth. “In the
current therapeutic landscape where there is no specific therapy in
RAP or in early CP that may hinder disease progression, these
findings warrant further investigation of selective CRAC channel
inhibitors as a potential novel treatment.”
Rachel Leheny, Ph.D., CalciMedica’s CEO,
commented, “CalciMedica has CRAC channel inhibitor compounds with
very similar profiles to CM5480 that are amenable to oral dosing
which we believe are well suited for application to chronic
pancreatitis. These compounds are moving through pre-IND studies
and could be ready for clinical studies in late 2024.”
About CalciMedicaCalciMedica is
a clinical-stage biopharmaceutical company focused on developing
therapies for life-threatening inflammatory diseases with high
unmet need. 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 design and
potential benefits of CalciMedica’s product candidates; and
CalciMedica’s ongoing and planned clinical trials. 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
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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