LA JOLLA, Calif. - CalciMedica Inc. (NASDAQ:CALC), a biopharmaceutical company, announced positive results from its Phase 2b CARPO trial evaluating Auxora for acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS). The study, presented at the American College of Gastroenterology 2024 Annual Scientific Meeting, indicated a significant reduction in severe respiratory failure and other critical endpoints in patients treated with high doses of Auxora compared to placebo.
The CARPO trial was a double-blind, placebo-controlled study involving 216 patients who received varying doses of Auxora or a placebo. The high-dose group showed a 100% relative risk reduction in new-onset severe respiratory failure and a 64.2% reduction in persistent respiratory failure. Additionally, the high dose led to a clinically meaningful decrease in new-onset necrotizing pancreatitis and shortened the time to medically indicated discharge.
Prof. Robert Sutton of the University of Liverpool, who chaired the Steering Committee for the trial, highlighted the significance of these findings, emphasizing the potential of Auxora to reduce mortality and morbidity associated with AP. Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, noted the consistency of Auxora's positive results across different acute critical diseases and its unique immunomodulatory action.
The company plans to discuss the Phase 3 trial design for Auxora with the FDA, focusing on AP patients with accompanying SIRS. CalciMedica is also conducting a Phase 2 trial in acute kidney injury patients with respiratory failure, expecting results next year.
Auxora, CalciMedica's lead clinical compound, is a selective inhibitor of CRAC channels, which are implicated in various inflammatory syndromes. The drug has shown promise in multiple clinical trials for different acute inflammatory conditions, including COVID pneumonia. There are currently no approved therapies for AP, which affects approximately 300,000 U.S. patients annually, with a significant number experiencing SIRS.
This announcement is based on a press release statement from CalciMedica. The company will be hosting a conference call and webcast to review the full data set from the CARPO trial.
In other recent news, CalciMedica has announced several key developments. The pharmaceutical company expanded its 2023 Equity Incentive Plan by 1.5 million shares, following approval from its stockholders. The company's Annual Meeting also resulted in the election of two Class I directors, Eric Bjerkholt and Fred Middleton, and the ratification of Moss Adams LLP as the principal independent registered public accounting firm for the fiscal year ending December 31, 2024.
In addition to these corporate governance activities, CalciMedica reported positive results from its Phase 2b CARPO trial in acute pancreatitis. The company is also advancing its Phase 2 KOURAGE study, investigating the treatment of acute kidney injury with associated acute hypoxemic respiratory failure. Topline data from this study is expected to be released next year.
CalciMedica is also preparing to initiate a Phase 3 trial in 2023, further exploring the efficacy and safety of Auxora in treating acute pancreatitis. Analyst firms such as Oppenheimer and Singular Research have maintained positive ratings for CalciMedica, citing the company's recent clinical advancements and the market potential of its treatments. These are some of the recent developments in the company's operations.
InvestingPro Insights
As CalciMedica (NASDAQ:CALC) reports promising results from its Phase 2b CARPO trial for Auxora, investors might be interested in the company's financial health and market performance. According to InvestingPro data, CalciMedica's market capitalization stands at $42.25 million, reflecting its position as a small-cap biopharmaceutical company.
The company's stock has shown significant volatility, with a 67.96% price total return over the past year, despite a recent 3-month decline of 23.54%. This performance aligns with the high-risk, high-reward nature of biotech stocks, especially those in the clinical trial phase.
InvestingPro Tips highlight that CalciMedica holds more cash than debt on its balance sheet, which is crucial for a company in the resource-intensive drug development phase. However, the company is also quickly burning through cash, a common characteristic of pre-revenue biotech firms investing heavily in R&D.
It's worth noting that CalciMedica is not currently profitable, with an operating income of -$21.45 million over the last twelve months. This is typical for companies in the clinical trial stage, as they focus on developing their pipeline rather than generating immediate revenue.
For investors considering CalciMedica's potential, InvestingPro offers 7 additional tips that could provide further insights into the company's financial position and market outlook. These additional tips could be particularly valuable given the company's upcoming discussions with the FDA regarding Phase 3 trial design for Auxora.
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