Eloxx Pharmaceuticals, Inc. (OTC: ELOX), a leader in ribosomal
RNA-targeted genetic therapies for rare diseases with nonsense
mutations, today provided significant pipeline and financing
updates.
“Dosing of the first healthy volunteers in the Phase 1 trial for
ZKN-013, our lead TURBO-ZM™ is a meaningful milestone for Eloxx, as
it further demonstrates our ability to advance novel candidates
targeting rare diseases into clinical trials,” said Sumit Aggarwal,
President and Chief Executive Officer of Eloxx. “We were also very
pleased with the outcome of our pre-IND meeting with the FDA, which
has increased our confidence in the potential of ELX-02 to have a
meaningful impact on the treatment of Alport syndrome.”
First patient dosed in Phase 1 clinical trial of
ZKN-013
The first two subjects have been dosed in the ongoing Phase 1
healthy volunteer single-ascending dose study of ZKN-013. ZKN-013
is designed to overcome nonsense mutations that cause a premature
stop codon resulting in nonfunctional protein production for
example in recessive Dystrophic Epidermolysis Bullosa (RDEB),
Junctional Epidermolysis Bullosa (JEB) and familial adenomatous
polyposis (FAP). This Phase 1 study evaluates the safety and
pharmacokinetics in healthy volunteers.
ZKN-013 has been exclusively licensed to Almirall, S.A.
(BME:ALM), who has global rights to develop and commercialize
ZKN-013. Under the terms of the license agreement, Eloxx is
eligible for additional development, regulatory and sales
milestones of up to $470 million as well as tiered royalties on any
potential global sales.
Positive feedback from the PIND meeting with FDA for
ELX-02 clinical development in NMAS patients in the US
Eloxx has received FDA’s final minutes from the hybrid in-person
and video conference PIND meeting the company held with the Office
of Cardiology, Hematology, Endocrinology, and Nephrology - Division
of Cardiology and Nephrology. We believe that the FDA’s positive
feedback and guidance provides a pathway to an IND application
submission to initiate a validating Phase 2 clinical trial in the
US with ELX-02 in NMAS patients. As part of the meeting, the FDA
reviewed the clinical data from the three patients from the Phase 2
trial conducted in the UK and provided feedback on the proposed
clinical trial design.
“We are grateful to the FDA for their engagement and support for
the clinical program to find an appropriate development path for
ELX-02 to treat NMAS patients,” said Sumit Aggarwal, President and
Chief Executive Officer of Eloxx. “Based on the FDA feedback and
guidance, Eloxx plans to engage with the FDA for a potential IND
application submission to the FDA to initiate a larger clinical
trial in the US to validate the results of its previously reported
Phase 2 study.”
In April 2024, the FDA Office of Orphan Products
Development (OOPD) granted Orphan Drug Designation for ELX-02
for the treatment of Alport Syndrome.
Secured binding commitment for an additional $3.2
million financing.
Eloxx recently secured financing with the lenders under its Loan
and Security Agreement, dated as of September 30, 2021 (as amended,
amended and restated, supplemented, or otherwise modified from time
to time) for an aggregate of $3.175 million financing of which
$500,000 has been funded in advance. This financing is in addition
to the $288,00 financing closed in May and both financings have
identical terms and conditions. This additional financing is
intended to support the advancement of our clinical programs and
provide funding for general corporate purposes. We expect to
receive the remainder $2.675 million of bridge loan financing
on or about July 12, 2024.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is engaged in the
science of ribosome modulation, leveraging 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 Phase 2 clinical development for the treatment of
Alport syndrome in patients with nonsense mutations. For more
information, please visit www.eloxxpharma.com.
Forward-looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements other than statements of historical facts contained
in this press release, including without limitation, statements
regarding the potential future payments and future benefits under
the license agreement, achievement of key milestones under the
license agreement, the expected timeline for clinical development,
the efficacy of the Company’s product candidates ZKN-013 and
ELX-02, the Company’s expected and planned communications with and
submissions to the FDA and anticipated funding under the bridge
loan 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: the Company’s incurrence of
significant losses; the Company has identified conditions and
events that raise substantial doubt about its ability to continue
as a going concern; its ability, or its licensees’ 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 the
Company’s, and its licensees’ preclinical studies and clinical
trials and other research and development activities; the
competition for patient enrollment from drug candidates in
development; the Company’s ability to obtain the capital necessary
to fund its operations; the cost of filing, prosecuting, defending
and enforcing any patent claims and other intellectual property
rights; the Company’s ability to obtain financing in the future
through product licensing, public or private equity or debt
financing or otherwise; general business conditions, regulatory
environment, competition and market for the Company’s 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 the Company’s Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2023, as any such
factors may be updated from time to time in the Company’s other
filings with the SEC, accessible on the SEC’s website at
www.sec.gov and the “Financials & Filings” page of the
Company’s website at
https://investors.eloxxpharma.com/financials-filings.
All forward-looking statements speak only as of
the date of this press release and, except as required by
applicable law, the Company has 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.
ContactJohn Woolfordjohn.woolford@westwicke.com
443.213.0506
Source: Eloxx Pharmaceuticals
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