XBiotech Announces Top-Line Results for 514G3 Antibody Therapy in Serious Staphylococcus aureus Infections
(Thomson Reuters ONE) -
Patients Receiving 514G3 Therapy Had Reduced Hospitalization and Fewer
Infection-Related Serious Adverse Events
AUSTIN, Texas, April 03, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT)
announced top-line results today from its double-blind, placebo-controlled,
phase I-II study evaluating the safety and efficacy of its FDA Fast Tracked true
human antibody (514G3) for the treatment of Staphylococcus aureus bloodstream
infections.
The study involved use of the Company's proprietary 514G3 antibody derived from
a natural human immune response against a key virulence determinant of S.
aureus that is present on all strains of the bacteria, including MRSA. In the
study, hospitalized adult patients with confirmed blood infections were
randomized 3:1 (514G3 vs placebo) during a dose escalation phase to establish a
Phase II dose. The Phase II portion was randomized 2:1 at the established Phase
II dose of 40 mg/kg. A total of 52 patients were enrolled: 36 received 514G3 and
16 received placebo. Thirty of the 36 patients that were given 514G3 received
the established Phase II dose (40 mg/kg).
The study was the first in-human use for 514G3 using exploratory endpoints in a
small population. Thus, the study was not powered to demonstrate statistically
significant outcomes. Nevertheless, several key topline results from the
clinical study were observed.
No drug-related adverse events were observed at any of the dose escalation
levels and the 40 mg/kg Phase II dose was established without any dose-limiting
toxicities (DLTs). The duration of hospitalization and incidence of serious
adverse events (SAEs) were key clinical endpoints which the Company is exploring
as a basis for evaluating effectiveness of the therapy. SAEs thus served as both
a measure of safety and of efficacy for the 514G3 therapy. Blinded analyses for
SAEs were independently performed by the study chair, treating investigators,
and an independent expert. A total of 28 SAEs in 15 patients were reported
during the study period including 4 deaths. There was a 49% relative risk
reduction for the overall incidence of SAEs in subjects receiving 514G3 compared
to those receiving placebo [(8 of 36 (22%) vs 7 of 16 (44%), respectively,
(p=0.11)]. There was an even greater risk reduction in the incidence of S.
aureus related SAEs in those that received 514G3 treatment compared to placebo,
with a 56% relative risk reduction in the 514G3 group [4 of 36 (11%) vs 4 of 16
(25%), respectively, (p=0.23)]. The trend seen with overall and disease specific
reduction in SAEs was a key outcome in the study and an important potential
indication of 514G3 efficacy.
Another clinically important secondary endpoint was the average length of
hospitalization for patients from the time they entered study. The duration of
hospitalization was reduced by about 33% in the 514G3 treatment arm compared to
the placebo arm [8.6±7 days vs 12.7±9 days, respectively (p=0.092)] [median 7.5
(IQR 4-9) vs median 12 (IQR 5.5-19), respectively]. Given the complexity of the
co-morbidities in the population and the small study size, observing reduced
hospital stay in the 514G3 group suggests a considerable impact on resolution of
disease, less patient morbidity and a potential reduction in healthcare
expenditures for subjects receiving the antibody therapy.
Dr. Mark E. Rupp, Principal Investigator of the study, Professor and Chief,
Division of Infectious Diseases, Medical Director, Department of Infection
Control & Epidemiology at the University of Nebraska, stated, "Novel treatments
for serious infections due to Staphylococcus aureus are critically needed.
Unfortunately, S. aureus is becoming increasingly resistant to antibiotics and,
due to the expanding need for medical devices, hemodialysis, advanced surgical
procedures, and an aging population, we can expect to see more and more people
infected with S. aureus. Results from the phase I-II trial are encouraging.
Despite the study being very small and 514G3-treated subjects tending to be
sicker, there were fewer adverse events and shorter hospitalization associated
with the 514G3 therapy.
John Simard, President & CEO of XBiotech, commented, "This first-in-human use of
514G3 used exploratory clinical endpoints to evaluate an important new antibody
therapy for patients with life-threatening infections. Given the effect sizes
such as reductions in SAEs and shortening of hospitalization time, in a small
group with extensive co-morbidiies, the study provided the signals we were
hoping to see."
Other findings in this study were that randomization failed in the small sample
size to provide well matched populations with respect to co-morbidities between
treatment and placebo arms. Subjects who were randomized in the 514G3 treatment
arm tended to be sicker and have greater numbers of serious co-morbid conditions
and greater risk of complications. Seventy-eight percent of the 514G3 treated
patients were admitted to the hospital via the Emergency Department vs 56% in
the placebo arm. In addition, observed differences in the primary diagnosis for
patients randomized to the 514G3 vs placebo arm included 4 (11%) vs 0 for stroke
and 4 (11%) vs 0 for sepsis, respectively. Conversely, for 9 (56%) of the
placebo arm patients vs only 11 (31%) of 514G3 patients, staphylococcus
infection was associated with underlying cellulitis, which is generally a more
mild form of the disease. Consequently, four deaths occurred in the treatment
arm vs none in the placebo group (p=0.30). The panel of experts certified in
blinded reviews that three of the deaths were unrelated to study drug. For one
death, there was uncertainty. Two of the three panel experts deemed that an
event for a patient admitted with an acute stroke that died one day following
receiving 514G3 treatment was "possibly" related to the test article. Autopsy
findings, however, revealed extensive atherosclerosis in the brain and concluded
that death was sequelae of a second stroke. Dr. Rupp further related, "Although
the deaths observed in the treatment arm of the study did not appear to be drug-
related, this will warrant careful evaluation in larger studies. Overall,
514G3 shows promise as an innovative adjunctive approach in the treatment of
serious infections due to S. aureus."
S. aureus bacteremia is a very serious medical problem that is associated with a
30-day mortality rate of 20%-30% despite treatment with antibiotics. S.
aureus is becoming increasingly resistant to antibiotics and new treatment
modalities are urgently needed. The CDC has graded methicillin-resistant S.
aureus (MRSA) as a serious threat to public health and estimates that over
80,000 serious MRSA infections occur in the U.S. each year resulting in over
11,000 deaths.
About True Human(TM) Therapeutic Antibodies
XBiotech's True Human(TM) antibodies are derived without modification from
individuals who possess natural immunity to certain diseases. With discovery and
clinical programs across multiple disease areas, XBiotech's True Human
antibodies have the potential to harness the body's natural immunity to fight
disease with increased safety, efficacy and tolerability.
About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to
pioneering the discovery, development and commercialization of therapeutic
antibodies based on its True Human(TM) proprietary technology. XBiotech
currently is advancing a robust pipeline of antibody therapies to redefine the
standards of care in oncology, inflammatory conditions and infectious diseases.
Headquartered in Austin, Texas, XBiotech also is leading the development of
innovative biotech manufacturing technologies designed to more rapidly, cost-
effectively and flexibly produce new therapies urgently needed by patients
worldwide. For more information, visit www.xbiotech.com.
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Contact
Ashley Otero
aotero(at)xbiotech.com
512-386-2930
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 03.04.2017 - 14:00 Uhr
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