Eloxx Pharmaceuticals Adds Additional Treatment Arm to Ongoing Phase 2 Clinical Studies for Cystic Fibrosis
30 April 2021 - 6:15AM
Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced the
addition of a new study arm in 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. The Phase 2 clinical
program now includes a fifth treatment arm to evaluate safety of
ELX-02 in combination with Kalydeco (ivacaftor), an FDA-approved
CFTR (CF transmembrane conductance regulator) potentiator for the
treatment of cystic fibrosis in patients who have at least one
mutation in their CF gene amenable to ivacaftor. The Phase 2 trials
are designed to evaluate the safety of ELX-02 and assess its
biological activity.
“We are extremely pleased to include this additional treatment
arm in the ongoing Phase 2 clinical trial to further explore the
potential of ELX-02 to treat cystic fibrosis,” said Sumit Aggarwal,
President and Chief Executive Officer. “Given ELX-02’s potential to
treat CFTR nonsense mutations and the synergistic effects of ELX-02
and ivacaftor seen to date in pre-clinical models, we believe that
combination treatment with a CFTR potentiator, such as ivacaftor,
provides the opportunity to improve clinical efficacy in the
treatment of CF. We remain on track to present data from the first
four treatment arms of the study in the second half of this
year.”
ELX-02 is currently in Phase 2 clinical trials in CF patients
affected by nonsense mutations in the CFTR gene. The trial
currently has sites in the U.S., Europe, Israel, Australia and
Canada. Several planned Safety Review Committee meetings have
occurred and allowed dose escalation up to the top dose level, and
data have shown no drug-related serious adverse events reported to
date. Multiple patients have progressed through the four-dose
escalation treatment range. 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
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Forward-looking statements are based on management's current
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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 Annual Report on
Form 10-K for the fiscal year ended December 31, 2020, 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.
Contact
InvestorsJohn
Woolfordjohn.woolford@westwicke.com443.213.0506
MediaLaureen Cassidylaureen@outcomescg.com
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