CalciMedica’s stock nosedived after the biotech abandoned a phase 2 study of its calcium release-activated calcium (CRAC) channel inhibitor in patients with acute kidney injury (AKI) over a “safety concern.”
The California biotech isn’t sharing any details of the nature of the safety concern, beyond saying that it was flagged by the study’s independent data monitoring committee (IDMC) during a prescheduled interim data review. CalciMedica had been evaluating the therapy, called Auxora, in the Kourage trial of patients with stage 2 or 3 AKI with associated acute hypoxemic respiratory failure (AHRF).
While this patient population is associated with high mortality, the company stressed that no deaths in the Kourage trial had been assessed as being related to Auxora. In addition, no serious adverse events met the criteria for expedited reporting to the FDA, the biotech noted.
Still, it marks a significant setback for the company’s AKI plans. As recently as November, the biotech touted plans to read out Kourage data in the first half of this year, after enrolling an expected 150 patients.
“Based on the IDMC’s feedback, we will review the unblinded Kourage data and explore modifications to the trial design, particularly patient enrollment criteria, that may support further clinical testing of Auxora in patients with AKI,” CalciMedica CEO Rachel Leheny, Ph.D., said in a Jan. 28 release.
This will involve assessing the “baseline characteristics, disease severity, concomitant therapies, and other factors on patient outcomes,” the company explained.
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“To date, no treatment-related safety concern has been observed across more than 350 critically ill patients treated with Auxora in completed clinical trials, including the phase 2b Carpo trial in acute pancreatitis (AP) and the phase 2 Cardea trial in severe COVID-19 pneumonia,” Leheny added.
Despite the setback in the AKI study, the CEO said the company “remain[s] optimistic about Auxora’s potential in acute inflammatory illnesses.”
Investors didn’t seem reassured by CalciMedica’s optimism, sending the company’s stock plunging 84% to 82 cents in premarket trading Wednesday from a Tuesday closing price of $5.12.
The biotech is still planning to work with the FDA in the coming months on a plan for a phase 3 study of Auxora in AP. The company also has a preclinical CRAC channel inhibitor in development for pulmonary arterial hypertension and rheumatoid arthritis.