LA JOLLA, Calif. - CalciMedica, Inc. (NASDAQ:CALC), a biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 2 trial of Auxora™, a treatment for acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). The trial, named KOURAGE, is set to start in the first half of 2024, with results expected in 2025.
Auxora is a small molecule inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels. The upcoming randomized, double-blind, placebo-controlled study will enroll 150 patients with stage 2 and 3 AKI who have AHRF. The trial's primary endpoint is to determine days alive and free from ventilators or dialysis through day 30. Secondary endpoints include a composite of mortality, a decrease in glomerular filtration rate, and the incidence of dialysis over 90 days.
AKI is a condition that signifies a sudden reduction in kidney function, often resulting from complications of serious illnesses. In the United States, there are roughly 1.1 million patients with stage 2 and 3 AKI, with more than half also suffering from AHRF. Currently, no approved therapies exist for AKI, which carries a high mortality risk.
The decision by the FDA was influenced by clinical and pre-clinical evidence supporting the potential benefits of Auxora. In a previous trial, CARDEA, treatment with Auxora showed a nearly 40% reduction in AKI among patients with severe and critical COVID-19 pneumonia compared to those treated with a placebo. Additionally, a post-hoc analysis revealed a survival benefit for Auxora-treated patients with compromised kidney function.
CalciMedica's pre-clinical studies also showed promising results. In an ischemia/reperfusion injury model of AKI, a single dose of Auxora increased glomerular filtration rate and decreased inflammatory cell infiltration. Further results from recent pre-clinical studies will be presented at the 29th International AKI & Continuous Renal Replacement Therapy Conference in March 2024.
This news is based on a press release statement from CalciMedica.
InvestingPro Insights
As CalciMedica (NASDAQ:CALC) forges ahead with its Phase 2 trial for Auxora™, investors may note some key financial metrics from InvestingPro that could provide context to the company's current market position. With a market capitalization of $61.19 million, CalciMedica is a smaller player in the biopharmaceutical industry. The company's performance over the last three months has been strong, with a price total return of 67.58%, and an even more impressive year-to-date return of 99.22%. These figures suggest increasing investor confidence in the company's prospects.
An InvestingPro Tip worth considering is that CalciMedica holds more cash than debt on its balance sheet, which could offer some financial flexibility as they advance their clinical trials. Additionally, the company does not pay a dividend to shareholders, indicating that it is likely reinvesting its earnings into research and development, which is common for biopharmaceutical companies in the growth phase.
However, it's important to note that according to InvestingPro data, the company is not profitable over the last twelve months, with a negative P/E ratio of -3.2 and an operating income of approximately -$20.66 million. This underlines the speculative nature of investing in biopharmaceutical firms, where the potential for future profits often hinges on the successful development and commercialization of their drug candidates.
For readers interested in a deeper dive into CalciMedica's financial health and future prospects, additional InvestingPro Tips are available. These include insights on cash burn rates and gross profit margins, which are crucial for understanding the sustainability of the company's current operations. To access these tips and more, visit https://www.investing.com/pro/CALC, and don't forget to use the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription. In total, there are 9 additional InvestingPro Tips available for CalciMedica, which can provide investors with a comprehensive understanding of the company's financial position and market potential.
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