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Combioxin SA is a clinical-stage company that develops innovative anti-virulence treatments for serious bacterial infections, including those caused by antibiotic-resistant strains. The lead candidate, CAL02, is a first-in-class, clinical-stage non-antibiotic liposomal drug that neutralizes bacterial toxins, protects against infection severity and complications, and improves antibiotic efficacy.

Despite current best-practice antibiotic therapy, vaccines and supportive health care, bacterial infections are still associated with high morbidity and mortality. Innovative anti-infective agents targeting bacterial toxins and steering clear from the emergence of drug resistance, have become a critical medical need and a focus of R&D investment both by the medical community and the pharmaceutical industry. They defy the most alarming infections which affect critically ill patients and they offer a chance for a wiser use of antibiotics.

Bacterial toxins are directly responsible for serious and fatal infection-related 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 antimicrobial prophylaxis and therapeutics.

CAL02 is currently being tested in a randomised, multicentre, double-blind, placebo-controlled, Phase I/IIa study aiming at assessing the safety, tolerability, and efficacy of CAL02 as adjunctive therapy to standard of care in ICU patients with severe pneumonia caused by Streptococcus pneumoniae.

The drug effectively neutralizes virulence factors produced by 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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