Basilea announces New England Journal of Medicine publication of
phase 3 data on ceftobiprole for the treatment of Staphylococcus
aureus bacteremia
Allschwil, Switzerland, September 28, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
announced today that data from the successful phase 3 study
ERADICATE were published in the New England Journal of Medicine
(NEJM), one of the world's leading peer-reviewed medical journals.1
In the study, Basilea’s ceftobiprole, a beta-lactam antibiotic, was
evaluated for the treatment of bacterial bloodstream infections
caused by Staphylococcus aureus in adult patients, also known as
Staphylococcus aureus bacteremia (SAB). ERADICATE is the largest
registrational study for SAB conducted to date and ceftobiprole
showed similar clinical benefit compared to daptomycin, which is a
standard of care antibiotic in the treatment of SAB.
ERADICATE was a double-blind, non-inferiority study, which
included 390 adult patients with complicated SAB, including
right-sided infective endocarditis, at 60 sites in 17 countries.2
Patients were randomized to receive infusions of ceftobiprole or
daptomycin (plus optional aztreonam) for up to 42 days.
The primary outcome of the study was overall treatment success
at 70 days after randomization defined by survival, bacteremia
clearance, symptom improvement, no new SAB-related complications,
and no receipt of other potentially effective antibiotics.
Using a pre-defined non-inferiority margin of 15%, treatment
with ceftobiprole was non-inferior to daptomycin with overall
treatment success achieved in 69.8% of patients in the ceftobiprole
group compared to 68.7% in the daptomycin group.
The results for the primary study outcome were consistent in key
subgroups, including patients with either methicillin-resistant
Staphylococcus aureus (MRSA) or methicillin-susceptible
Staphylococcus aureus (MSSA). Clearance of MRSA bacteria from the
bloodstream was achieved in 93.3% of patients in the ceftobiprole
group compared with 87.8% in the daptomycin group after a median of
5 days of treatment, and clearance of MSSA bacteria from the
bloodstream was achieved in 94.3% of patients in the ceftobiprole
group after a median of 3 days of treatment compared with 95.2% in
the daptomycin group after a median of 4 days of treatment.
Ceftobiprole was generally well tolerated and showed a safety
profile consistent with previous phase 3 studies and the
post-marketing experience. The overall percentage of patients
reporting adverse events was similar between the two treatment
groups with more patients reporting gastrointestinal adverse events
in the ceftobiprole group, typical for the beta-lactam class of
antibiotics. There were no reports of Clostridioides difficile
infections in either group.
Thomas Holland, M.D., Associate Professor in the department of
Medicine at Duke University School of Medicine and chair of the
data review committee of the study, said: “This is an area with a
high need to provide new treatments to patients and there has not
been a new antibiotic approved for the treatment of Staphylococcus
aureus bacteremia for over 15 years.”
Vance G. Fowler, Jr., M.D., Professor in the departments of
Medicine and Molecular Genetics & Microbiology at Duke
University School of Medicine and academic lead investigator,
added: “Complicated Staphylococcus aureus infections have a high
mortality rate and are associated with substantial morbidity and we
need more options for treating these infections, especially if MRSA
is involved.”
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated:
“The data from the ERADICATE study published in the NEJM support
the potent activity of ceftobiprole for treating serious bacterial
infections. Based on ERADICATE and additional randomized controlled
phase 3 studies, we have recently submitted a New Drug Application
to the US Food and Drug Administration, seeking approval of
ceftobiprole for treating patients in three indications:
Staphylococcus aureus bacteremia, including right-sided infective
endocarditis, acute bacterial skin and skin structure infections
and community-acquired bacterial pneumonia.”
Basilea’s ceftobiprole phase 3 program is funded in part with
federal funds from the US Department of Health and Human Services
(HHS); Administration for Strategic Preparedness and Response
(ASPR); Biomedical Advanced Research and Development Authority
(BARDA), under contract number HHSO100201600002C. Basilea has been
awarded approximately USD 112 million, or approximately
75 percent of the costs related to the phase 3 studies in SAB and
acute bacterial skin and skin structure infections (ABSSSI),
regulatory activities and non-clinical work.
About ceftobiprole
Ceftobiprole, the active moiety of the prodrug ceftobiprole
medocaril, is an advanced generation cephalosporin antibiotic for
intravenous administration, with rapid bactericidal activity
against a wide range of Gram-positive bacteria such as
Staphylococcus aureus, including methicillin-resistant strains
(MRSA), and Gram-negative bacteria.3 The brand is currently
approved and marketed as Zevtera® and Mabelio® in several countries
in Europe and beyond for the treatment of adult patients with
hospital-acquired bacterial pneumonia (HABP), excluding
ventilator-associated bacterial pneumonia (VABP), and for the
treatment of community-acquired bacterial pneumonia (CABP). Basilea
has entered into license and distribution agreements covering more
than 80 countries. Ceftobiprole is currently not approved or
partnered in the US. Ceftobiprole was designated a Qualified
Infectious Disease Product (QIDP) by the US Food and Drug
Administration (FDA) for SAB, ABSSSI and CABP. Therefore, if
approved, ceftobiprole would be eligible to receive ten years of
market exclusivity in the US from the date of approval.
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded
in 2000 and headquartered in Switzerland. We are committed to
discovering, developing and commercializing innovative drugs to
meet the needs of patients with severe bacterial or fungal
infections. We have successfully launched two hospital brands,
Cresemba for the treatment of invasive fungal infections and
Zevtera for the treatment of bacterial infections. In addition, we
have preclinical anti-infective assets in our portfolio. Basilea is
listed on the SIX Swiss Exchange (SIX: BSLN). Please visit
basilea.com.
Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements, such as "believe", "assume", "expect",
"forecast", "project", "may", "could", "might", "will" or similar
expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its
business, including with respect to the progress, timing and
completion of research, development and clinical studies for
product candidates. 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, Allschwil to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Basilea Pharmaceutica Ltd, Allschwil 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 RelationsBasilea Pharmaceutica
International Ltd, Allschwil Hegenheimermattweg 167b4123
AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.com investor_relations@basilea.com |
This press release can be downloaded from www.basilea.com.
References
- T. L. Holland, S. E. Cosgrove,
S. B. Doernberg et al. Ceftobiprole for treatment of
complicated Staphylococcus aureus bacteremia. New England Journal
of Medicine 2023 Sep 27; DOI: 10.1056/NEJMoa2300220. Epub ahead of
print.
- ERADICATE: ClinicalTrials.gov identifier NCT03138733
- Summary of Product Characteristics (SmPC) Zevtera:
https://www.medicines.org.uk/emc/product/9164/smpc [Accessed
September 27, 2023]
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