CalciMedica Presents Data from Preclinical Studies of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference

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Therapeutic treatment with Auxora shown to hasten the recovery of kidney function and improve survival in a rat model of acute kidney injury (AKI) Preclinical results are consistent with clinical observations made with Auxora, supporting the KOURAGE trial in patients with severe AKI that will start enrolling in 2Q 2024 LA JOLLA, Calif. , March 13, 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, last evening presented data from preclinical studies of Auxora™ in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. David Basile , Ph.D., Professor of Anatomy, Cell Biology and Physiology at Indiana University , gave an oral and poster presentation entitled "The Store-Operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-Induced Acute Kidney Injury in Rats." "At AKI & CRRT, Prof. Basile discussed the most recent preclinical study of Auxora in an acute kidney injury model that used a treatment regimen of three daily doses of drug started six hours after ischemic injury, which resembles the dosing in our clinical protocol. The positive results from this study build on prior preclinical data and indicate that inhibiting Orai1 activity in an AKI model improves kidney function," said Kenneth Stauderman , Ph.D., Founder and Chief Scientific Officer of CalciMedica . "In rats with ischemic kidney injury akin to Stage 2 AKI, Auxora was shown to provide nearly complete recovery of kidney function, as evidenced by improved glomerular filtration rate (GFR) at 72 hours after injury, while placebo-treated animals showed little improvement in GFR. In rats with kidney injury akin to Stage 3 AKI, the rats treated with placebo died while those on Auxora survived and showed modest recovery of GFR. We are excited as these studies support clinical observations of Auxora that suggest the drug may be beneficial for AKI patients." AKI is a serious acute critical illness and denotes a sudden reduction in kidney function, or the organ's ability to clean and filter the blood, that results from a complication of critical illness. These animal model studies support observations from CalciMedica's clinical trials, particularly CARDEA, the Company's Phase 2 trial in patients with severe and critical COVID-19 pneumonia, where AKI was a relatively common co-morbidity or a common sequela of the disease. Compared to placebo-treated patients, Auxora-treated patients in CARDEA had lower levels of key biomarkers associated with kidney injury, lower incidence of treatment-emergent AKI and reduced mortality in those patients with decreased kidney function at the time of treatment. Additionally, previous preclinical studies conducted by CalciMedica and others suggest that Orai1 activity contributes to the activation and infiltration of pro-inflammatory Th17 cells in the kidney, which is associated with the development of AKI. CalciMedica has also shown that the active ingredient in Auxora, zegocractin, inhibits release of IL-17, which is a key pro-inflammatory cytokine from Th17 cells. "As we initiate KOURAGE, our Phase 2 trial of Auxora in severe AKI patients with associated acute hypoxemic respiratory failure, we are encouraged to have additional supporting data showing that Auxora has beneficial activity in animal models of AKI," said Sudarshan Hebbar , M.D., Chief Medical Officer of CalciMedica . "Patients randomized in KOURAGE will have Stage 2 and Stage 3 AKI, so the results from Prof. Basile's recent preclinical study, most notably the survival benefit, are particularly meaningful. Severe AKI in the presence of respiratory failure has a mortality of approximately 50% and we are heartened to see that Auxora has the potential for a positive impact on patients with this devastating disease." Data Presented at the AKI & CRRT Conference The data presented at AKI & CRRT was from a series of studies referred to as Study 1 and Study 2. In Study 1, AKI was induced in a rat model through ischemia reperfusion injury (I/R), a transient ligation of the renal artery, while control animals underwent sham-surgery. Within 30 minutes of injury, the animals were treated with a single intravenous infusion of either 16 mg/kg of Auxora or placebo over a period of 4 hours. GFR, an important indicator of kidney function, was evaluated at 24 hours post-injury. Study 2 evaluated recovery of kidney function following I/R similar to Study 1 but varying in intensity to mimic different severity of disease. In Study 2, GFR was measured 2-4 hours after injury but before treatment, and treatment with 16 mg/kg of Auxora or placebo was administered at 6, 24 and 48 hours post-injury, with GFR again evaluated at 72 hours. Results from Study 1 showed that at 24 hours post-injury, GFR was significantly higher in rats treated with Auxora 30 minutes after injury versus placebo (61%, p

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