Clinical Trials

Date: 2012-06-15

Type of information:

phase: 1-2

Announcement: enrolment of the first patient

Company: Kenta Biotech (Switzerland)

Product: KBSA301

Action mechanism: KBSA301 is a fully human monoclonal antibody. Irt was identified by using Kenta Biotech’s proprietary MabIgX® technology. In the field of infectious diseases, this is one of the few therapeutic monoclonal antibodies that is tested in a first-in-human trial directly in patients.
KBSA301 binds to Staphylococcal alpha-toxin, thus preventing the toxin from damaging the lungs of the patients. Its mode of action is independent from the antibiotic resistance profile of S. aureus, therefore covering both MRSA (methicillin-resistant S. aureus) and MSSA (methicillin-sensitive S. aureus). This constitutes a significant progress in the treatment of severe S. aureus infections. The therapeutic activity of KBSA301 demonstrated in preclinical animal studies resulted in a significant survival benefit for treated animals. This, along with an excellent safety profile enabled Kenta Biotech to obtain permission from health authorities in four major countries to test the antibody on intensive care unit patients with severe S. aureus pneumonia.

Disease: severe pneumonia caused by Staphylococcus aureus (S. aureus)

Therapeutic area: Infectious diseases

Country: France, Belgium, Spain, UK

Trial details: In this clinical trial, 44 patients suffering from severe pneumonia caused by S. aureus admitted in intensive care units around Europe will be administered a single dose of KBSA301, or placebo, in addition to standard antibiotic therapy.
This first-in human phase I/II clinical trial is entitled “A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamics of a Single Intravenous Administration of KBSA301 in Severe Pneumonia caused by S. aureus”.  The trial is registered at (Identifier: NCT01589185).

Latest news: Kenta Biotech has announced that the first patient was enrolled in the phase I/II clinical trial with KBSA301, a fully human antibody for the treatment of severe pneumonia caused by Staphylococcus aureus (S. aureus). With this study, Kenta Biotech accelerates the clinical development of KBSA301. The trial is already running in France, where the first patient was included in the trial. This month, patient enrolment will start in Belgium and Spain, and later this year in the UK.

Is general: Yes