Preclinical data show that therapeutic
treatment with Auxora in a rat model of AKI improves kidney
function as measured by glomerular filtration rate
LA
JOLLA, Calif., Feb. 28,
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 diseases, today announced that data
from its most recent preclinical study of Auxora™ (zegocractin) in
acute kidney injury (AKI) will be presented in a poster and oral
presentation at the 29th International Acute Kidney
Injury and Continuous Renal Replacement Therapy Conference (AKI
& CRRT) being held March 12-15,
2024 in San Diego, CA.
The data will highlight the promising therapeutic benefits of
Auxora in a rat model of AKI and suggest that Auxora can hasten
recovery of renal function. The study was conducted to evaluate
whether the selective CRAC channel inhibitor Auxora would improve
glomerular filtration rate (GFR), an important indicator of kidney
function, when given therapeutically in a rat model of AKI induced
by ischemia reperfusion injury, a timed ligation of the renal
artery.
Presentation Title: The Store-operated Calcium Channel
Inhibitor Auxora Improves Renal Function Following Ischemia-induced
Acute Kidney Injury in Rats
Presenter: David P.
Basile, Ph.D., Indiana
University
Session Date and Time: Tuesday,
March 12, 5:30-7:30 p.m.
Session Title: Oral Session 2: Translational
Research
About AKI
Acute kidney injury (AKI) denotes a sudden
reduction in kidney function, or the organ's ability to clean and
filter the blood, as measured by increased serum creatinine (a
cellular waste product) or decreased urine volume. 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 hospitalized
with AKI in the United States each
year. The majority have Stage 1 AKI and recover with supportive
care alone. However, approximately 1.1 million of these patients
advance to stage 2 and stage 3 AKI, over half of whom have
associated acute hypoxemic respiratory failure (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 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 pancreatic acinar
cells, 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) as a side effect of pediatric acute
lymphoblastic leukemia treatment with asparaginase, (iii) a Phase 2
dose-ranging pharmacodynamic study in critical COVID-19 patients,
and (iv) a Phase 2 trial in AKI with associated AHRF, called
KOURAGE expected to initiate in the first half of 2024. There are
currently no approved therapies to treat either AP, AIPT or AKI. 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 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 for a planned 216 patients (called CARPO
– NCT04681066) for AP with SIRS, with topline data expected in the
first half of 2024, as well as supporting the ongoing Phase 1/2
CRSPA AIPT study (called CRSPA – NCT04195347), with additional data
expected by 2H 2024. CalciMedica plans to initiate its Phase 2
KOURAGE study in AKI in 1H 2024. 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,
statements regarding CalciMedica's planned and ongoing clinical
trials and the timing, design and expected patient enrollment
thereof, including its planned Phase 2 KOURAGE trial of Auxora in
AKI with associated AHRF, its ongoing Phase 2b trial of Auxora for AP with accompanying SIRS,
its ongoing Phase 1/2 trial of Auxora in pediatric patients with
AIPT; the potential benefits of Auxora for the treatment of AKI, AP
and AIPT; the estimated patient population in the United States for AKI; the expected timing
for release of data in CalciMedica's ongoing clinical trials; and
plans to present results from CalciMedica's pre-clinical studies in
a rat model of AKI induced by ischemia reperfusion injury at the
29th International AKI & Continuous Renal Replacement Therapy
Conference. 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 September
30, 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 Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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SOURCE CalciMedica, Inc.
