Full Press Release Details
CalciMedica Presents AKI Data from a Post-Hoc Analysis of the
Phase 2 CARDEA trial of Auxora in Severe COVID-19 Pneumonia at the 30th International
AKI & CRRT Conference
62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated
with Auxora versus placebo in subset of patients in CARDEA with AKI
LA JOLLA, Calif., Mar. 4, 2025 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 Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered a plenary presentation at the 30th International Acute Kidney Injury and
Continuous Renal Replacement Therapy Conference (AKI & CRRT) on March 3, 2025 in San Diego, CA. The presentation outlined the role of CRAC channels in acute kidney injury (AKI) pathophysiology and included new data highlighting the
potential of CalciMedica s lead product candidate, Auxora , in AKI. CalciMedica is currently conducting a Phase 2 trial of Auxora in patients with Stage 2 or Stage 3 AKI and acute
hypoxemic respiratory failure, which is expected to read out in 2025.
The new data presented were based on a
post-hoc analysis from the previously completed Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia. The study included 38 patients who enrolled with AKI,
defined as an estimated glomerular filtration rate (eGFR) 60 ml/min/1.73 m², in addition to moderate or severe respiratory failure, which was an inclusion criterion. Within this subset:
This reduction in mortality in the patient subset with AKI exceeded that of the entire study population. In the entire population (n = 261), a 56.3% (p =
0.017) relative reduction versus placebo in mortality at day 30 was observed, with an absolute reduction of 9.9% versus placebo.
In his presentation,
Dr. Hebbar also summarized previously disclosed data supporting the role of CRAC channel inhibition as a potential therapeutic mechanism in AKI. Key data include:
As illustrated by these data, the biological rationale for CRAC channel
inhibition as a potential therapeutic mechanism for AKI is compelling, said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. The post-hoc analysis from CARDEA is especially relevant
given that the 62.7% relative reduction in mortality was observed in patients with both kidney failure and respiratory failure, which mirrors the intended patient population for our ongoing Phase 2 KOURAGE study.
The presentation is now available on the Medical Events & Presentations section of CalciMedica s IR website at
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 data for a Phase 2b trial (called CARPO NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic
inflammatory response syndrome (SIRS). The Company has also 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 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA
NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (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, results of post-hoc analyses from the previously completed Phase 2 CARDEA trial of Auxora and CalciMedica s ongoing and planned
clinical trials and the timing and design thereof, and the expected timing for the release of data from those trials, including its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its ongoing Phase 2 KOURAGE trial of
Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; 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. 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, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on November 13, 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.
Sarah Sutton/Kevin Murphy