Combioxin announces milestone in the field of infectious diseases

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03.05.2019
Bacteria

By neutralizing bacterial toxins over which antibiotics are powerless, Combioxin’s CAL02 creates a new paradigm in the field of infectious diseases. Today, The Lancet Infectious Diseases published the first clinical results with CAL02, in severe pneumonia patients, showing safety and consistent superiority over placebo in all efficacy parameters.

Combioxin's CAL02 consists of liposomes engineered to catch and neutralize a large panel of bacterial toxins known to cause severe and deadly complications. It does not induce resistance, and can be administered before pathogen identification and on top of antibiotics.

The clinical trial – reported today in The Lancet Infectious Diseases – aimed at assessing the safety and efficacy of CAL02 administered in addition to standard of care. The trial was carried out in intensive-care-unit (ICU) patients with severe community-acquired pneumococcal pneumonia.

Despite best antibiotic treatments, pneumonia is still the first cause of infectious mortality in the world. The World Health Organization estimates that pneumonia affects 450 million people every year worldwide, 20% of whom require hospitalization. Besides the suffering and high mortality rates, severe community-acquired pneumonia also represents a high economic burden due to prolonged hospitalization and to the fact that more than 20% of hospitalized patients require ICU management.

This first-in-human trial was a randomized, double-blind, placebo-controlled study conducted in hospitals in Belgium and France. This study was carried out in a severe population where 58% of the 19 recruited patients were in septic shock and 42% under invasive mechanical ventilation at the time of treatment. Patients received two intravenous administrations of CAL02 or placebo, with a 24- hour interval, and were followed during 29 days. A sentinel group of patients received CAL02 at a dose of 4 mg/kg, and then the trial focused on a dose of 16 mg/kg.

The primary objective of the study was met: CAL02 was shown to be as safe as placebo. Furthermore, The Lancet Infectious Diseases reports that, as compared to patients under placebo, patients who were treated with CAL02 presented a faster clinical improvement, including a significantly faster resolution of organ dysfunctions (as per SOFA score). Efficacy was in line with the mode of action of the drug, which aims at protecting organs, including the respiratory and cardiovascular systems. Within one week the cardiovascular and hemodynamic status of treated patients were fully normalized and stable, while no improvement was observed in the placebo arm during the same period. Moreover, CAL02-treated patients remained under invasive mechanical ventilation for an average of 4.5 days, as compared to 12 days for patients receiving standard of care without CAL02. Cure of pneumonia was more rapid with CAL02. Inflammatory biomarkers, such as C-reactive protein (CRP) and procalcitonin (PCT) showed immediate decrease and full normalization within the first 48 hours after the start of treatment with CAL02, as opposed to immediate increases in the placebo arm. The Lancet Infectious Diseases also reports that CAL02-treated patients were kept in the ICU for an average of 5 days, as opposed to 12 days in the placebo arm.

Along with this publication, The Lancet Infectious Diseases issued a Comment entitled “One step closer to precision medicine for infectious diseases” ranking “this study a medical breakthrough”. The authors assert that “CAL02 represents a milestone“ and that CAL02 is “potentially suitable for adjunctive empirical treatment”.

(Press release)

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