CalciMedica (CALC) said Wednesday it has reached alignment with the US Food and Drug Administration on the endpoints and patient selection criteria for a planned phase 2b trial of Auxora in acute pancreatitis.

The company said the regulator aligned on the new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints.

Alignment was also reached on a strategy to assess whether elevated lactate dehydrogenase can identify patients at greater risk of developing severe disease, CalciMedica said.

Results from the phase 2b trial are expected to help confirm patient selection criteria and inform the design and endpoint of a phase 3 program, the company said.

CalciMedica said it is engaging with a contract research organization and holding discussions with potential clinical sites for the study.

Shares of CalciMedica were up 1.4% in Wednesday trading.

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