CalciMedica has terminated a Phase II study on its lead asset, Auxora (zegocractin), in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) – causing the company’s stock value to plummet.
This follows a recommendation from the independent data monitoring committee, which identified an unspecified safety concern that “warrants re-evaluation of the study design”, particularly around patient enrolment.
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While CalciMedica has provided little information on the KOURAGE trial’s (NCT06374797) termination, the biopharma did note that there were no Auxora-related deaths in the study. There were also no serious adverse events (SAEs) that met the criteria for expedited reporting to the US Food and Drug Administration (FDA).
Despite the company’s assurances on Auxora’s safety, investors seem to have lost faith in the programme, as CalciMedica’s stock value dropped over 83% from $5.12 at market close on 27 January to an opening value of $0.85 on 28 January. The biopharma’s stock later settled at a value of $1.25 at market close on 28 January, marking a 75% decrease.
Before its cessation, the KOURAGE trial was evaluating Auxora in patients with Stage 2 or 3 AKI with AHRF. There are currently no approved targeted treatment options available for this patient population.
In a bid to progress Auxora’s development in AKI, CalciMedica will review the unblinded clinical data – evaluating the impact of disease severity, baseline characteristics and concomitant therapies. This evaluation will guide the company’s next development steps for the calcium release-activated calcium (CRAC) inhibitor in AKI.
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By GlobalDataOutside of the AKI patient population, CalciMedica’s CEO, Rachel Leheny, noted that the biopharma is currently finalising the design of a pivotal trial on Auxora in acute pancreatitis (AP). Pending FDA feedback, the study design should be complete by the first half of 2026, Leheny said.
The future of treating AKI
According to a 2025 paper published in the Journal of Intensive Medicine, AKI is one of the most frequent complications associated with sepsis and cardiac surgery, with this potentially life-threatening occurrence impacting between 30-50% of patients.
It is also common worldwide, with GlobalData, parent company of Clinical Trials Arena, estimating that around 199 in 100,000 people will experience AKI.
There are currently no approved targeted therapies for the treatment of AKI, with the standard of care (SoC) revolving around addressing the underlying cause, managing fluid balance and maintaining a patient’s blood pressure levels.
There are a few drugs in development for AKI prevention in specific patient subgroups. One of these is AstraZeneca-owned Alexion Pharmaceuticals’ complement inhibitor, Ultomiris (ravulizumab), which is being evaluated as a potential treatment to reduce the risk of cardiac surgery-associated AKI in patients with chronic kidney disease (CKD) in the Phase III ARTEMIS trial (NCT05746559).
