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CAL02 is an investigational, first-in-class anti-infective agent designed to neutralize bacterial virulence factors rather than directly killing bacteria. It consists of proprietary engineered liposomes composed primarily of cholesterol and sphingomyelin (egg), which act as decoys to capture and sequester a broad range of toxins produced by both Gram-positive and Gram-negative bacteria, including ESKAPE pathogens. By binding these virulence effectors, CAL02 prevents them from damaging host tissues, disrupting immune defenses, or triggering pro-inflammatory cascades that can lead to organ failure and septic shock. Unlike antibiotics, CAL02 does not exert selective pressure on bacteria or disrupt beneficial flora and is active regardless of the resistance profile of the pathogen. Its mechanism is complementary to antibiotics; it can be administered empirically alongside standard care for severe community-acquired bacterial pneumonia (SCABP) to reduce complications and improve outcomes[1][2][4][5][6][7].
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