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Combioxin SA is a clinical-stage company that develops innovative treatments protecting from virulent effectors causing organ dysfunction and inflammation in patients with severe infections. The lead candidate, CAL02, is a first-in-class, Phase 2 liposomal drug that acts as a shield against pathogen's virulent effectors such as toxins, and protects against severe complications, to dramatically improve standard of care.

Despite current best-practice antibiotic therapy, vaccines and supportive health care, bacterial infections are still associated with high morbidity and mortality.

Virulent effectors such as bacterial toxins are directly responsible for acute and fatal complications, extended hospitalization and tremendous increases in cost of care. Toxins are weapons used by bacteria to colonize our body, invade our organs, and block our immune defenses. They play multifactorial and fundamental roles in initiation, dissemination, persistence, and severity of infection. Because of their almost ubiquitous presence in bacterial pathogens, they are important targets for broadly applicable therapeutics.

The safety, tolerability, and efficacy CAL02 has been successfully tested in a randomised, multicentre, double-blind, placebo-controlled, Phase I/IIa study aiming at assessing CAL02 as adjunctive therapy to standard of care in ICU patients with severe pneumococcal pneumonia.

In this fist-in-human clinical trial, CAL02 proved safe and well tolerated, and patients treated with CAL02 recovered significantly faster than patients treated with placebo in addition to best available treatments.

The drug effectively neutralizes virulence factors produced by the most clinically relevant Gram+ and Gram- pathogens such Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa and various other streptococcal or clostridium strains. It is therefore active against the most frequent bacteria - including antibiotic-resistant pathogens (e.g. MRSA) - that cause severe infections such as community- and hospital-acquired pneumonia, ventilator-associated pneumonia, other nosocomial infections and meningitis.

 

 

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