Basilea starts clinical phase 3 study with antibiotic ceftobiprole in Staphylococcus aureus bacteremia (SAB)|
Basilea Pharmaceutica AG /
Basilea starts clinical phase 3 study with antibiotic ceftobiprole in
Staphylococcus aureus bacteremia (SAB)
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Basel, Switzerland, August 09, 2018 - 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.
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company
developing products that address the medical challenge of increasing resistance
and non-response to current treatment options in the therapeutic areas of
bacterial infections, fungal infections and cancer. With two commercialized
drugs, the company is committed to discovering, developing and commercializing
innovative pharmaceutical products to meet the medical needs of patients with
serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is
headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX:
BSLN). Additional information can be found at Basilea's website www.basilea.com.
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
any future results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any forward-
looking statements contained herein as a result of new information, future
events or otherwise.
For further information, please contact:
| Peer Nils Schröder, PhD |
| Head of Corporate Communications & Investor Relations |
| +41 61 606 1102 |
| firstname.lastname@example.org |
| email@example.com |
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),
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
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Source: Basilea Pharmaceutica AG via GlobeNewswire
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