Last week Kenta Biotech announced an important step towards a more efficient treatment of hospital infections: 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).
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. KBSA301 is developed by Kenta Biotech as a new treatment option to fight severe S. aureus infections, including those caused by antibiotic resistant strains. Founded six years ago, Swiss biotech start-up Kenta today is a leader in the field of antibody treatment in nosocomial infections.
The fully human monoclonal antibody KBSA301 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. Kenta Biotech, in this way, can accelerate the clinical development and bringing this new compound faster to patients.
Novel approach for treatment of infections
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.
Franco Merckling, CEO said: “This is a great day for patients, for doctors and for Kenta Biotech. Thanks to intensive research and the dedication of our outstanding staff, we are able to bring a human monoclonal antibody with an innovative mode of action into clinical development in record time. I am confident that this trial will deliver promising data and pave the way for change in the treatment of severe S. aureus pneumonia.”
Toni Perez, Chief Medical Officer said: “We are very excited about this clinical trial. For more than 25 years, I have been developing new anti-infective drugs, and I have never seen a drug with such tremendous potential. Patients and doctors have been eagerly waiting for a solution like the one to be expected from KBSA301.”
About the trial KBSA301-001
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“. 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. The trial is registered at Clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01589185).
About KBSA301 KBSA301 is a fully human monoclonal antibody that targets a virulence factor of S. aureus called alpha-toxin, which is a highly toxic protein secreted by both MRSA and MSSA strains during the course of the infection. Using Kenta Biotech’s proprietary MabIgX® technology, a range of human monoclonal antibodies against alpha-toxin has been generated, from which KBSA301 was selected for clinical development due to its outstanding toxin neutralisation properties. The mode of action of KBSA301 is independent from the microbiological sensitivity of S. aureus to antibiotics, and constitutes significant progress in the treatment of life-threatening S. aureus infections.
Source: Kenta Biotech