Arsanis Provides Update Following Completion of Planned Interim Analysis of Phase 2 Clinical Trial of ASN100
28 Juni 2018 - 1:00PM
Trial Unlikely to Meet Primary Efficacy Endpoint;
Arsanis to Cease Trial Enrollment and Evaluate Complete
Clinical Trial DatasetArsanis to Continue Focus on Development of
ASN500 for Prevention of RSV Infection
Arsanis, Inc. (NASDAQ:ASNS), a clinical-stage biopharmaceutical
company focused on applying monoclonal antibody immunotherapies to
address serious infectious diseases, today announced the
discontinuation of its Phase 2 clinical trial of ASN100 for the
prevention of S. aureus pneumonia in high-risk, mechanically
ventilated patients following the completion of a planned interim
analysis of unblinded trial data by an independent data review
committee (DRC). Based on the results of this analysis, the DRC
determined that the trial was futile, meaning that it was not
likely to meet its primary end-point upon completion and
recommended that trial enrollment be discontinued. Arsanis intends
to conduct follow-up visits on all patients dosed with ASN100 per
the study protocol.
“We are disappointed that this clinical study was futile despite
the survival benefit of ASN100 as compared to placebo observed in
preclinical models of pneumonia, however Arsanis remains confident
in the potential of monoclonal antibodies to prevent and treat
serious infections, while also reducing the threat of antibiotic
resistance,” said René Russo, President and Chief Executive Officer
of Arsanis. “We intend to evaluate the complete dataset from the
patients that were enrolled in the ASN100 study to better
understand the basis for this result and expect to provide an
update on the program following this review. We thank the
patients and their caregivers who participated in the ASN100 Phase
2 study.”
Dr. Russo continued, “We will continue to focus our efforts and
resources on our other programs, including the development of
ASN500 for the prevention of respiratory syncytial virus (RSV)
infection, which contributes to 240,000 hospitalizations per year
in the U.S. Pre-clinical data for ASN500 has demonstrated high
potency with potential to offer benefits over existing preventive
therapies in terms of dosing strategy, manufacturing and route of
administration, to better serve both new and existing target
patient populations. We expect to advance ASN500 into Phase 1
clinical trials in 2019.”
About the ASN100 Phase 2 Clinical TrialThe
ASN100 Phase 2 clinical trial was a double-blind,
placebo-controlled superiority trial evaluating the efficacy and
safety of ASN100 for the prevention of S. aureus pneumonia in
high-risk, mechanically ventilated patients, an indication for
which there are no approved therapies. The primary efficacy
endpoint of the trial was the proportion of patients who develop S.
aureus pneumonia through 21 days after dosing. The trial was
designed to detect a 50% reduction in the occurrence of S. aureus
pneumonia in the ASN100 arm when compared to placebo.
About ASN100 ASN100 is a combination of two
co-administered fully human monoclonal antibodies (mAbs), ASN-1 and
ASN-2, that together neutralize the six cytotoxins critical to S.
aureus pneumonia pathogenesis. ASN-1 neutralizes
alpha-hemolysin (Hla), a cytotoxin that damages lung epithelial
cells, and four leukocidins, cytotoxins that destroy human immune
cells: gamma-hemolysin AB (HlgAB), gamma-hemolysin CB (HlgCB),
Panton-Valentine leukocidin (PVL), and leukocidin ED (LukED). ASN-2
neutralizes the fifth leukocidin, LukGH, a particularly potent
human cytotoxin also responsible for the destruction of human
immune cells.
About ArsanisArsanis, Inc. is a
clinical-stage biopharmaceutical company focused on applying
monoclonal antibody (mAb) immunotherapies to address serious
infectious diseases. A deep understanding of the pathogenesis of
infection, paired with access to some of the most advanced mAb
discovery techniques and platforms available today, has positioned
Arsanis to further its goal of building and advancing a pipeline of
novel mAbs with multiple mechanisms of action and high potency
against their intended targets. The Company’s pipeline is comprised
of mAbs targeting multiple serious bacterial and viral pathogens,
including respiratory syncytial virus.
Arsanis is a U.S. company headquartered in Waltham,
Massachusetts, with a wholly owned subsidiary that is primarily
focused on discovery research in Vienna, Austria (Arsanis
Biosciences GmbH).
For more information, please visit the Arsanis website at
www.arsanis.com.
Cautionary note regarding forward-looking
statementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve substantial risks and
uncertainties, including statements regarding: the planned analysis
of data from the ASN100 trial; the potential benefits of monoclonal
antibodies to prevent and treat serious infections, while reducing
the threat of antibiotic resistance generally; plans and prospects
for ASN500; and statements regarding Arsanis’ strategy, prospects,
plans and objectives of management. The words “anticipate,”
“advance,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “look forward,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would,” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements Arsanis’ makes as a result of
important factors, including, but not limited to: uncertainties
inherent in the availability and timing of data from the stopped
Phase 2 trial of ASN100; Arsanis’ ability to advance the
development of its programs under the timelines it projects,
demonstrate the requisite safety, efficacy and combinability of its
drug candidates and/or replicate scientific and non-clinical data
in clinical trials; the content and timing of decisions made by the
U.S. Food and Drug Administration and other regulatory authorities
and investigational review boards at clinical trial sites; Arsanis'
ability to obtain and maintain requisite regulatory approvals;
competitive factors; Arsanis' ability to obtain, maintain and
enforce patent and other intellectual property protection for any
product candidates it is developing; the availability of cash
resources, Arsanis’ ability to manage expenses, and its need for
additional financing; Arsanis’ ability to successfully execute on
its business strategies; and other important risk factors as set
forth in filings that Arsanis periodically makes with the U.S.
Securities Exchange Commission, or SEC, including the risk factors
described under the caption “Risk Factors” in its Annual Report on
Form 10-K for the year ended December 31, 2017, as updated in its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
each of which is on file with the SEC. The forward-looking
statements contained in this press release reflect the current
views of Arsanis with respect to future events, and Arsanis assumes
no obligation to update any forward-looking statements except as
required by applicable law.
Media Contact:Jennifer Paganelli,
347-658-8290 jpaganelli@purecommunications.com
Investor Contact:Michael Gray,
781-819-5201Chief Operating and Chief Financial
Officermike.gray@arsanis.com
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