Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the start of a clinical phase 3 study with its antibiotic ceftobiprole. The registration study evaluates the safety and efficacy of ceftobiprole in the treatment of patients with bacteremia (bloodstream infections) caused by Staphylococcus aureus.
David Veitch, Chief Executive Officer, said: "We are very pleased to have started the SAB study. This is the second of our two phase 3 studies that are required to potentially gain a U.S. marketing authorization. SAB and associated complications cause significant morbidity and mortality, in particular if caused by methicillin-resistant Staphylococcus aureus, MRSA. With its broad spectrum of activity, including MRSA, ceftobiprole has the potential to become an important treatment option for patients with these serious hospital bacterial infections."
The randomized, double-blind, multi-center study aims to establish the safety and efficacy of intravenously (i.v.) administered ceftobiprole versus i.v. daptomycin (plus optional aztreonam for Gram-negative infections) in the treatment of SAB. The FDA-agreed primary endpoint is to demonstrate non-inferiority of ceftobiprole to the comparator regimen at the post-treatment evaluation visit 70 days after randomization. The study is anticipated to enroll approximately 390 adult patients. Additional information on this clinical study is available at www.clinicaltrials.gov (identifier: NCT03138733).
A first phase 3 study was started in February which evaluates ceftobiprole in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The two phase 3 studies are designed to be cross-supportive for a potential U.S. registration and are conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Basilea's ceftobiprole phase 3 program is funded in part (up to USD 118 million, which is approximately 70% of the total estimated program costs) with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600002C.
Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.1 Ceftobiprole is approved in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1 Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. It is currently marketed in major European countries, Argentina, Canada and Saudi Arabia under the brand names Zevtera® and Mabelio®. The drug received Qualified Infectious Disease Product (QIDP) designation in the U.S. from the FDA for the potential treatment of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). Based on the QIDP designation ceftobiprole would be eligible for priority review of a future New Drug Application (NDA) and market exclusivity of ten years upon approval in the U.S. Ceftobiprole is currently in a phase 3 clinical program for registration in the U.S. under an SPA with the FDA. The SPA provides agreement between Basilea and the FDA that the design and planned analysis of a clinical study adequately address the objectives necessary to support a regulatory submission for the approval of a drug in the U.S.
About Staphylococcus aureus bacteremia (SAB)
Staphylococcus aureus bacteremia is a leading cause of bloodstream infections, responsible for a broad variety of complications and has been associated with significant morbidity and a mortality of 20 to 40%.2, 3 Several studies have demonstrated that MRSA bacteremia is associated with a significantly higher mortality rate compared with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.4, 5 Infections of the inner lining of the heart or heart valves (infective endocarditis) and bone infections (osteomyelitis) are common complications of SAB.
This press release can be downloaded from www.basilea.com.
1 UK Summary of Product Characteristics (SPC) Zevtera: http://www.mhra.gov.uk/ [Accessed: August 08, 2018]
2 A. G. Jensen et al. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Archives of Internal Medicine 2002 (162), 25-32
3 J. L. Wang et al. Comparison of both clinical features and mortality risk associated with bacteremia due to community-acquired methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical Infectious Diseases 2008 (46), 799-806
4 S. I. Blot et al. Outcome and attributable mortality in critically Ill patients with bacteremia involving methicillin-susceptible and methicillin-resistant Staphylococcus aureus. Archives of Internal Medicine 2002 (162), 2229-2235
5 S. E. Cosgrove et al. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59