Eloxx Pharmaceuticals Provides Enrollment Update for Ongoing Phase 2 Clinical Studies for Cystic Fibrosis
July 06 2021 - 4:15PM
Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today provided an
update on enrollment for the ongoing global Phase 2 clinical
program for ELX-02 for the treatment of cystic fibrosis (CF) in
patients with at least one G542X allele. Based on enrollment to
date, Eloxx expects to present data from the first four treatment
arms of the study in the fourth quarter of this year. As of the end
of June 2021, Eloxx has enrolled a sufficient number of patients to
assess biological activity of ELX-02. Eloxx will continue to enroll
additional patients to support Phase 3 clinical trial planning. The
Phase 2 trials are designed to evaluate the safety of ELX-02 and
assess its biological activity.
“Given the substantial efforts of our clinical team, we have
made considerable progress in enrolling patients in our ongoing
Phase 2 clinical program to explore the potential of ELX-02 to
treat cystic fibrosis,” said Sumit Aggarwal, President and Chief
Executive Officer. “Given this progress, we are positioned to
present data from the first four treatment arms of the study in the
fourth quarter of this year.”
ELX-02 is currently in Phase 2 clinical trials in CF patients
affected by nonsense mutations in the CFTR (CF transmembrane
conductance regulator) gene. The trial currently has sites in the
U.S., Europe, Israel, Australia and Canada. Following several
planned Safety Review Committee meetings, dose escalation has
proceeded up to the top dose level, and data have shown no
drug-related serious adverse events reported to date. Recently, a
fifth treatment arm was added to the program to evaluate the safety
of ELX-02 in combination with Kalydeco (ivacaftor), an FDA-approved
CFTR potentiator for the treatment of cystic fibrosis in patients
who have at least one mutation in their CF gene amenable to
ivacaftor.
The program is partially funded by the Cystic Fibrosis
Foundation (CFF).
The U.S. Food and Drug Administration has granted orphan drug
designation for ELX-02 for the treatment of CF.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is engaged in the science of
ribosome modulation, leveraging both its innovative TURBO-ZM™
chemistry technology platform in an effort to develop novel
Ribosome Modulating Agents (RMAs) and its library of Eukaryotic
Ribosome Selective Glycosides (ERSGs). Eloxx’s lead investigational
product candidate, ELX-02, is a small molecule drug candidate
designed to restore production of full-length functional proteins.
ELX-02 is in clinical development focusing on cystic fibrosis.
ELX-02 is an investigational drug that has not been approved by any
global regulatory body. Eloxx also has preclinical programs focused
on select rare diseases including inherited diseases, cancer caused
by nonsense mutations, kidney diseases, including autosomal
dominant polycystic kidney disease, as well as rare ocular genetic
disorders.
For more information, please visit www.eloxxpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements other than statements of present and
historical facts contained in this press release, including without
limitation, statements regarding the expected timing of trials and
results from clinical studies of our product candidate, the
expansion of our clinical trial sites and the potential of our
product candidate to treat nonsense mutations are forward-looking
statements. Forward-looking statements can be identified by the
words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,”
“plan,” “anticipate,” “could,” “intend,” “target,” “project,”
“contemplate,” “believe,” “estimate,” “predict,” “potential,”
“seeks,” or “continue” or the negative of these terms similar
expressions, although not all forward-looking statements contain
these words.
Forward-looking statements are based on management's current
plans, estimates, assumptions and projections based on information
currently available to us. Forward-looking statements are subject
to known and unknown risks, uncertainties and assumptions, and
actual results or outcomes may differ materially from those
expressed or implied in the forward-looking statements due to
various important factors, including, but not limited to: our
ability to progress any product candidates in preclinical or
clinical trials; the uncertainty of clinical trial results and the
fact that positive results from preclinical studies are not always
indicative of positive clinical results; the scope, rate and
progress of our preclinical studies and clinical trials and other
research and development activities; the competition for patient
enrollment from drug candidates in development; the impact of the
global COVID-19 pandemic on our clinical trials, operations,
vendors, suppliers, and employees; our ability to obtain the
capital necessary to fund our operations; the cost of filing,
prosecuting, defending and enforcing any patent claims and other
intellectual property rights; our ability to obtain financial in
the future through product licensing, public or private equity or
debt financing or otherwise; general business conditions,
regulatory environment, competition and market for our products;
and business ability and judgment of personnel, and the
availability of qualified personnel and other important factors
discussed under the caption “Risk Factors” in our Quarterly Report
on Form 10-Q for the quarterly period ended March 31, 2021, as any
such factors may be updated from time to time in our other filings
with the SEC, accessible on the SEC’s website at www.sec.gov and
the “Financials & Filings” page of our website at
https://investors.eloxxpharma.com/financial-information/sec-filings
All forward-looking statements speak only as of the date of this
press release and, except as required by applicable law, we have no
obligation to update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
SOURCE: Eloxx Pharmaceuticals, Inc.
Contact
InvestorsJohn
Woolfordjohn.woolford@westwicke.com443.213.0506
MediaLaureen Cassidylaureen@outcomescg.com
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