New Clinical Trial in Patients with Critical COVID-19 Pneumonia
The trial is designed to accumulate additional patient safety data with Auxora, assess the safety and efficacy of Auxora in combination with both tocilizumab and corticosteroids, and assess the safety and efficacy of three versus six days of dosing. The Company recently reported topline data from its CARDEA Phase 2 trial that support further studies in this patient population.
CARDEA-Plus will enroll COVID-19 pneumonia patients with a PaO2/FiO2 (P/F) ratio of ≤200 who require high-flow nasal cannula (HFNC) or noninvasive ventilation (NIV). Patients will receive a 2.0 mg/kg initial dose of Auxora followed by 1.6 mg/kg at 24 hours, and 1.6 mg/kg at 48 hours. Those patients with either a P/F ratio of ≤100 or on mechanical ventilation at 48 hours will be eligible to be randomized to receive either three doses of Auxora or three doses of placebo. All patients will receive standard of care which may include the use of corticosteroids and/or tocilizumab.
“Despite increasing vaccination rates for COVID-19, the high number of hospitalizations and deaths still pose a significant problem,” said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. “While tocilizumab has become widely used in patients hospitalized with COVID-19, there continues to be a need to improve patient outcomes. We believe Auxora has a unique mechanism of action and pharmacokinetic properties that may provide clinical benefit to patients with critical COVID-19 pneumonia.”
“The initiation of this study, which also allows for administration of Auxora with tocilizumab and corticosteroids in patients with critical COVID-19 pneumonia, is a significant milestone for our Company,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Importantly, the results of this study, to be followed by discussions with the FDA, will inform the design of a potential Phase 3 clinical trial later this year. We have received broad enthusiasm and support from investigator sites for this study and anticipate rapid enrollment.”