Combioxin Highlights Results from Successful CAL02-001 First-in-Human Trial Evaluating CAL02 in Severe Pneumonia at ESICM 2018
Geneva, Switzerland, 24 October 2018 – Combioxin SA, a clinical-stage biotechnology company focused on the development of innovative treatments for severe and resistant infections, announced an Oral Presentation highlighting successful first-in-human clinical results with CAL02 in severe pneumonia patients in ICU, at the ESICM’s annual congress, LIVES 2018, in Paris today.
CAL02 is an investigational broad-spectrum agent administered QD on 2 consecutive days, which neutralizes bacterial toxins that cause widespread damages leading long-term and fatal complications.
The randomized, multicenter, double-blind, placebo-controlled CAL02-001 trial was carried out in France and Belgium and led by Dr. Bruno François, University Hospital of Limoges, France, and Prof. Laterre, Saint Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium. Adult patients admitted to the ICU due to severe community-acquired pneumococcal pneumonia were treated with CAL02 Low Dose (4 mg/kg), CAL02 High Dose (16 mg/kg), or Placebo, in addition to standard-of-care therapy. At baseline, 56% of patients were in septic shock and 42% under invasive mechanical ventilation.
The primary objectives of the CAL02-001 trial were successfully achieved: CAL02 was shown to be safe and well tolerated, and, despite the small study population (nineteen patients randomized), consistent numerical superiority was observed in favor of the CAL02 High dose arm as compared to Placebo:
- After one week, more than 50% of patients achieved clinical cure in the CAL02 High dose arm as compared to 20% in the placebo arm
- CAL02-treated patients presented a faster clinical improvement, including faster resolution of organ dysfunctions
- ICU’s length of stay was reduced by one week, from 12 days in the Placebo arm to 5 days in CAL02 High dose arm
- Other parameters directly impacting health economics such as durations of invasive mechanical ventilation were also shorter in the CAL02 High dose arm
“Efficacy results from the CAL02-001 trial are in line with the mechanism of action of CAL02 which aims at protecting from toxin-mediated organ damages and inflammatory burst, and underscore the need for novel approaches acting in addition to antibiotics to improve treatment of severe infections” said Dr. Toni Perez, Combioxin’s Chief Medical Officer. “This trial showcases the broad utility of CAL02 as a first-line treatment for severe infection and we look forward to confirming these trends in a larger Phase 2 trial next year.”
“The results of the first-in-human CAL02-001 clinical trial provide evidence of the safe profile of CAL02 and its potential to dramatically improve the management of patients in critical situations caused by severe infections” said Prof. Laterre, Head of the medical-surgical intensive care unit at Saint Luc University Hospital at the Université Catholique de Louvain (Brussels, Belgium).
Pneumonia is still the fourth most common cause of death globally and is associated with a high economic burden mainly due to long hospital stay and the fact that more than one fifth of hospitalized patients will require intensive care unit management. Despite adequate antibiotic therapy and best available care, the length of stay in the ICU averages 13 days and mortality rates can reach up to 40%.
The CAL02-001 data will be presented by Professor Pierre-François Laterre, Principal Investigator for the trial, during the oral presentation session Management of Patients with Sepsis on Wednesday, October 24, 2018 at 10:10 a.m. EST.
CAL02 is a novel liposomal agent that acts as a toxin-trap by mimicking microdomains used as cellular docking stations by various bacterial toxins which prompt inflammatory bursts, cause organ damages, favor invasiveness, impede immune defenses, and are also involved in mechanisms of resistance. CAL02 is designed to protect against these deleterious reactions, allowing a faster resolution of organ dysfunction and protecting immune responses. CAL02 is active against toxins produced by major pathogens responsible for common and severe infections including those caused by drug-resistant pathogens.
Combioxin SA is a Swiss-based clinical-stage biotechnology company founded in 2015. The company is committed to the development of disruptive treatments for severe infections.
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