ContraFect Announces Independent DSMB Recommends Exebacase Phase 3 DISRUPT Study Be Stopped for Futility Following Interim Analysis
July 13 2022 - 3:05PM
ContraFect Corporation (Nasdaq:
CFRX), a biotechnology company focused on the discovery
and development of direct lytic agents (DLAs), including lysins and
amurin peptides, as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections, announces today
that the Data Safety Monitoring Board (DSMB) of the DISRUPT (Direct
Lysis of Staph aureus Resistant Pathogen Trial) study has
completed a pre-specified, interim futility analysis and the DSMB
recommended that the trial be stopped because the conditional power
of the study was below the pre-specified threshold for futility.
The recommendation was based on an analysis of
the clinical response rate at day 14 (the primary efficacy endpoint
of the study) in 84 patients, or approximately 60% of the total
planned methicillin-resistant Staphylococcus aureus (MRSA)
population with bacteremia, including right-sided endocarditis.
While further review of the data is ongoing, the company is
initiating steps to notify investigators that patient enrollment in
the trial is being stopped based on the DSMB recommendation.
“This disappointing news reflects the long
history of difficulties in treating life-threatening infections
like MRSA bacteremia in patients with heterogeneous co-morbidities,
and who are in need of immediate life-saving treatments. We are
sincerely grateful to all the patients, their families and the
investigators who participated in the trial,” stated Roger J.
Pomerantz, M.D., ContraFect’s President, Chief Executive Officer,
and Chairman.
The company plans to provide further details
regarding the development of exebacase following completion of its
own analysis of the accrued study data.
The Phase 3 DISRUPT study of exebacase is a
randomized, double-blind, placebo-controlled clinical study
conducted in the U.S. to assess the efficacy and safety of
exebacase in approximately 350 patients with complicated S.
aureus bacteremia, including right-sided endocarditis. The
primary efficacy endpoint is clinical response at Day 14 in
patients with MRSA bacteremia, including right-sided endocarditis.
Secondary endpoints include clinical response at Day 14 in the
All S. aureus patients (MRSA and
methicillin-sensitive S. aureus (MSSA)), 30-day all-cause
mortality in MRSA patients, and clinical response at later
timepoints.
About ContraFect
ContraFect is a biotechnology company focused on
the discovery and development of DLAs, including lysins and amurin
peptides, as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections. An estimated
700,000 deaths worldwide each year are attributed to
antimicrobial-resistant infections. We intend to address life
threatening infections using our therapeutic product candidates
from our platform of DLAs, which include lysins and amurin
peptides. Lysins are a new class of DLAs which are recombinantly
produced antimicrobial proteins with a novel mechanism of action
associated with the rapid killing of target bacteria, eradication
of biofilms and synergy with conventional antibiotics. Amurin
peptides are a novel class of DLAs which exhibit broad-spectrum
activity against a wide range of antibiotic-resistant Gram-negative
pathogens, including P. aeruginosa, Acinetobacter
baumannii, and Enterobacter species. We believe that the
properties of our lysins and amurin peptides will make them
suitable for targeting antibiotic-resistant organisms, such as MRSA
and P. aeruginosa, which can cause serious infections such as
bacteremia, pneumonia and osteomyelitis. We have completed a Phase
2 clinical trial for the treatment of Staph
aureus bacteremia, including endocarditis, with our lead lysin
candidate, exebacase, which is the first lysin to enter clinical
studies in the U.S. Exebacase was granted Breakthrough Therapy
designation by the FDA for the treatment of MRSA bloodstream
infections, including right-sided endocarditis, when used in
addition to SOC anti-staphylococcal antibiotics.
Follow ContraFect on
Twitter @ContraFectCorp and LinkedIn.
This project has been supported in whole or in
part with federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority
(BARDA), under contract number 75A50121C00021.
Forward-Looking Statements
This press release contains, and our officers
and representatives may make from time to time, “forward-looking
statements” within the meaning of the U.S. federal securities laws.
Forward-looking statements can be identified by words such as
“projects,” “may,” “will,” “could,” “would,” “should,” “believes,”
“expects,” “anticipates,” “estimates,” “intends,” “plans,”
“potential,” “promise” or similar references to future periods.
Examples of forward-looking statements in this release include,
without limitation, statements regarding further details as to how
ContraFect intends to proceed with the development of exebacase
following full completion of its own analysis of all of the data
sets from the Phase 3 clinical study of exebacase. Forward-looking
statements are statements that are not historical facts, nor
assurances of future performance. Instead, they are based on
ContraFect’s current beliefs, expectations and assumptions
regarding the future of its business, future plans, strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent risks, uncertainties and
changes in circumstances that are difficult to predict and many of
which are beyond ContraFect’s control, including the occurrence of
any adverse events related to the discovery, development and
commercialization of ContraFect’s product candidates such as
unfavorable clinical trial results, insufficient supplies of drug
products, the lack of regulatory approval, or the unsuccessful
attainment or maintenance of patent protection and other important
risks detailed under the caption “Risk Factors” in ContraFect's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022
and its other filings with the Securities and Exchange Commission.
Actual results may differ from those set forth in the
forward-looking statements. Any forward-looking statement made by
ContraFect in this press release is based only on information
currently available and speaks only as of the date on which it is
made. Except as required by applicable law, ContraFect expressly
disclaims any obligations to publicly update any forward-looking
statements, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Investor Relations Contacts:
Michael MessingerContraFect
CorporationEmail: mmessinger@contrafect.com
Media:
Jules AbrahamCORE IREmail: Julesa@coreir.com
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