CalciMedica has reported positive clinical data from the trial of its lead clinical compound, Auxora, in patients with severe Covid-19 pneumonia.
Auxora is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels.
In the open-label, placebo-controlled trial, 17 severe Covid-19 pneumonia patients were randomised to receive Auxora plus standard of care while nine patients received standard of care (SoC)alone.
According to the data, patients receiving Auxora plus SoC had lowered levels of D-dimer, a major clotting and inflammation marker, while patients receiving SoC alone had increased levels.
Furthermore, two patients, who received SoC alone developed femoral deep vein thrombosis, with one advancing to a pulmonary embolism. No patients receiving the Auxora treatment developed thromboembolic disease.
CalciMedica chief medical officer Sudarshan Hebbar said: “We remain encouraged by the positive results that we have seen from the use of Auxora in severe Covid-19 pneumonia.
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“These new data provide further evidence of the significance of CRAC channel inhibition in preventing inflammation in a number of ways, and we look forward to sharing more data demonstrating the benefits of Auxora in Covid-19 in addition to acute pancreatitis in the coming months.”
Auxora has shown rapid recovery and reduced use of invasive mechanical ventilation and death in patients with severe Covid-19 pneumonia versus SoC alone.
In addition, a blinded, placebo-controlled trial to evaluate Auxora versus placebo, with SoC in both arms is enrolling up to 400 severe Covid-19 pneumonia patients.
In this study, patients will be given either Auxora or matched lipid nano-emulsion placebo in addition to SoC, which may include both remdesivir and dexamethasone.
Enrolment of patients is expected to take place in up to 40 sites across the US.