Kenta Biotech announced today that the European Commission has granted ‘Orphan Drug’ status to Kenta Biotech’s product KBSA301 for the treatment of severe pneumonia caused by Staphylococcus aureus (S. aureus).
In addition to KBSA301, Kenta Biotech’s pipeline contains several additional compounds targeting nosocomial infections.
KBSA301 is the first fully human monoclonal antibody being developed for the treatment of severe S. aureus pneumonia. In spite of preventive measures and current antibiotic therapy, there is a substantial unmet medical need for additional treatment options for severe cases of pneumonia caused by S. aureus. The addition of KBSA301 to standard of care antibiotic therapy is anticipated to decrease mortality and recovery time in hospitalised patients.
S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide, both hospital- and community-acquired. Their frequencies have increased steadily and treating them has become more challenging due to the emergence of multi-drug-resistant strains. In developed countries, resistance to β-lactam antibiotics in methicillin-resistant S. aureus strains (MRSA) is a major problem. Notably, the incidence rate of all invasive MRSA infections, including those in and outside of hospitals, is high compared with other bacterial pathogens and 20% of these infections result in death.
KBSA301 is a fully human monoclonal antibody targeted against 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 represents a significant progress in the treatment of life-threatening S. aureus pneumonia.
The EU Regulation on orphan medicinal products is designed to encourage the development and marketing of treatments for rare (affecting fewer than 5 out of 10’000 people), life-threatening diseases with a lack of effective therapies.
“This European orphan drug designation represents an important milestone for our company,” said Franco Merckling, Kenta’s CEO. “It will allow us to benefit from free scientific advice from the European Medicines Agency (EMA) and will therefore significantly facilitate the direction of our clinical development and the subsequent filing of our registration dossier”.
The orphan drug designation has important advantages:
- EMA protocol assistance to optimise drug development;
- Facilitating access to the centralized authorisation procedure for marketing approval;
- Waiver of fees associated with applying for marketing approval and protocol assistance;
- Following drug approval the company is granted 10 years of marketing exclusivity in the EU;
- Access to EU research funding for rare diseases
Kenta Biotech is a biopharmaceutical company headquartered in Zurich, Switzerland, focusing on the development of innovative fully human monoclonal antibodies for the prevention and treatment of life-threatening infections. Kenta Biotech’s proprietary MabIgX® technology allows harnessing the power of the human immune system for the generation of fully human monoclonal antibodies and to transform them into highly effective therapeutic antibodies. The unique technology in combination with focused scientific and clinical expertise enables Kenta Biotech to rapidly move innovative antibody therapies from bench to high medical need patients.
Kenta Biotech‘s lead-product, KBPA101, has successfully completed a Phase IIa proof-of-concept trial addition to KBSA301, several product candidates are in preclinical development.