Candidate: Auxora™ (formerly CM4620-IE)
Type: Potent and selective small molecule CRAC channel inhibitor designed to prevent CRAC channel overactivation
Status: CalciMedica on May 28 announced positive topline data from an interim analysis of its open-label randomized controlled clinical study of Auxora (formerly CM4620-IE) in patients with severe COVID-19 pneumonia on low-flow oxygen therapy. The interim analysis showed Auxora plus standard of care reduced ventilator use and improved time to recovery in treated patients compared to standard of care alone.
Treated patients had a greater than 50% reduction in the proportion of patients put on ventilators in the course of therapy as compared to standard of care patients, while the length of hospital stay for Auxora treated patients was more than 50% shorter than for standard of care patients, CalciMedica reported. The open-label study consisted of 26 patients enrolled while on low-flow oxygen and randomized 2:1 to receive Auxora versus standard of care.
A week earlier, CalciMedica said, the FDA “strongly” recommended that the company transition its Phase II trial (NCT04345614) assessing Auxora in patients with severe COVID-19 pneumonia from an open-label study to a blinded placebo-controlled trial as soon as possible. CalciMedica said it was heeding the recommendation, which came after Calcimedica submitted to the agency an interim analysis it conducted after the study’s Independent Safety Review Committee (ISRC) recommended that the trial continue without modification. The ISRC weighed in a week after it was expanded to include assessing patients with critical COVID-19 pneumonia on high-flow nasal cannula oxygen therapy, citing a shift in treatment protocols to less-invasive therapies than mechanical ventilators.
The expansion has doubled the number of patients with COVID-19 pneumonia to be enrolled, to 120. Half will be in the additional study arm in critical patients on high-flow oxygen therapy, which aims to enroll 40 patients randomized to receive Auxora and 20 randomized to standard of care alone. The initial study arm of severe COVID-19 pneumonia patients on low-flow oxygen therapy has commenced; it aims to enroll 40 patients randomized to Auxora plus standard of care and 20 randomized to standard of care alone. CalciMedica began dosing in the original arm in April after receiving a “Study May Proceed” letter from the FDA.
Regions Hospital in St. Paul, MN, Henry Ford Hospital in Detroit and additional sites across the U.S have been dosing severe and critical COVID-19 pneumonia patients with Auxora.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: