Arsanis Provides Update Following Completion of Planned Interim Analysis of Phase 2 Clinical Trial of ASN100
Trial Unlikely to Meet Primary Efficacy Endpoint;
and Evaluate Complete Clinical Trial Dataset
“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
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 Trial
The 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.
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.
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Cautionary note regarding forward-looking statements
This 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
Chief Operating and Chief Financial Officer
Source: Arsanis, Inc.