– Results further support therapeutic potential of Auxora in respiratory diseases and other inflammatory diseases –
LA JOLLA, Calif., April 14, 2022 – CalciMedica Inc. (CalciMedica or the Company), the CRAC (calcium release-activated calcium) channel company, today announced the publication of results from the Company’s CARDEA clinical trial, a Phase 2 trial of Auxora in severe COVID-19 pneumonia, in Critical Care, a peer-reviewed, international medical journal. The article, titled “Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial,” details the trial findings on Auxora, CalciMedica’s lead CRAC channel inhibitor product candidate.
“Auxora was noted to hasten recovery, reduce mortality, and was well-tolerated in patients hospitalized with COVID-19 pneumonia and moderate to severe hypoxemic respiratory failure,” said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. “These findings provide support for the continued development of Auxora and suggest that Auxora may potentially have therapeutic benefit for respiratory failure due to other causes in addition to COVID-19 pneumonia.”
CARDEA is a Phase 2, randomized, double-blind, placebo-controlled trial evaluating the addition of Auxora to corticosteroids and standard of care in adults with severe COVID-19 pneumonia. Eligible patients were adults with more than one symptom consistent with COVID-19 infection, a diagnosis of COVID-19 confirmed by laboratory testing using polymerase chain reaction or other assay, and pneumonia documented by chest imaging. Patients were also required to be receiving oxygen therapy using either a high flow or low flow nasal cannula at the time of enrollment and, for the 261 patients in the analysis set, to have at the time of enrollment, a baseline imputed PaO2/FiO2 ratio > 75 and ≤ 200. The PaO2/FiO2 was imputed from a SpO2/FiO2 determined by pulse oximetry using a non-linear equation. Patients could not be receiving either non-invasive or invasive mechanical ventilation at the time of enrolment. The primary endpoint was time to recovery through Day 60, with secondary endpoints of all-cause mortality at Day 30 and Day 60.
The major findings of the Phase 2 trial as reported in Critical Care are as follows:
- Time to recovery was seven vs. ten days (P = 0.0979) for patients who received Auxora vs. placebo, respectively.
- Day 30 all-cause mortality was 7.7% with Auxora vs. 17.6%, with placebo (P = 0.0165).
- Day 60 all-cause mortality was 13.8% with Auxora vs. 20.6% with placebo (P = 0.1449).
- Serious adverse events occurred in 24.1% of patients treated with Auxora vs. 35% of patients receiving Placebo (P=0.0616).
“These data demonstrate Auxora’s potential to address severe and critical COVID-19 and potentially further our ability to treat the disease using an alternative mechanism of action, while also advancing our knowledge of the use of Auxora in respiratory diseases more generally,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “We are encouraged by the findings as they support the potency and versatility of Auxora in respiratory diseases as well as in other inflammatory diseases. We look forward to sharing clinical updates on Auxora from other trials throughout this year and next.”
Auxora is being evaluated in multiple indications, including acute pancreatitis with accompanying systemic inflammatory response syndrome, and acute kidney injury. The CARDEA-Plus follow-up trial to CARDEA in COVID-19 pneumonia patients was recently halted, prior to enrolling any patients, due to declining COVID-19 cases and re-evaluation of the optimal clinical path forward for Auxora in COVID-19 pneumonia. The Company is focusing on its Auxora clinical programs in acute pancreatitis and acute kidney injury while assessing opportunities to study Auxora in respiratory failure and acute respiratory distress syndrome (ARDS) due to all viral pneumonia, including COVID-19 pneumonia, based on the CARDEA results.