Almirall, S.A. (BME:ALM) and
Eloxx
Pharmaceuticals, Inc. (OTC: ELOX) announced today that the
companies have entered into
an exclusive license agreement
for the asset ZKN-013. Under the agreement, Almirall
obtains global rights to develop and commercialize ZKN-013,
including for the use in orphan dermatological diseases.
ZKN-013 is a potentially promising oral, nonsense
mutation readthrough drug, which enables the host cells to produce
functional proteins which counteract the root cause of these rare
dermatological and potentially other diseases.
The drug candidate is expected to shortly enter
into Phase I development in healthy volunteers.
As part of this agreement, Eloxx will receive an
upfront of $3 million, and additional payments throughout the
potential development phases, including regulatory and sales
milestones of up to $470 million, as well as tiered royalties based
on any potential future global sales.
"We are very excited about this agreement with
Almirall to develop and distribute ZKN-013, our lead TURBO-ZM™
based molecule, as we believe it has the potential to have a
significant impact on the treatment of these painful and
debilitating diseases,” said Sumit Aggarwal, President and
Chief Executive Officer of Eloxx. “In addition to
advancing development of ZKN-013, this agreement will allow Eloxx
to remain focused on fully maximizing the potential of ELX-02 in
rare kidney diseases and continue funded discovery efforts on our
TURBO-ZM™ platform.”
“This license agreement is aligned with
Almirall’s R&D strategy to develop novel treatments to help
people with dermatological conditions, including rare diseases,”
said Karl Ziegelbauer, Executive Vice President R&D and
Chief Scientific Officer of Almirall. “We look forward to
progressing the development of ZKN-013 to find a potentially
impactful solution for patients suffering from rare and devastating
diseases caused by nonsense mutations.”
RDEB /JEB are rare skin
diseases characterized by defects in the Collagen7 gene which is
essential for the correct formation of the skin structure and
barrier function. ZKN-013 has demonstrated robust functional
preclinical activity in RDEB/JEB patient cells and in APCmin
(multiple intestinal neoplasia) mice. The studies demonstrated that
ZKN-013 induces the production of functional, full-length COL7 in
RDEB patient cells.
ZKN-013 is also being developed for the
treatment of FAP patients with nonsense mutations characterized by
proliferation of colon polyps and progression to colon cancer. FAP
is a rare GI disease with patients progressing to colon cancer
caused by mutations in the APC gene.
ZKN-013 is Eloxx’s lead TURBO-ZM based molecule.
Eloxx's TURBO-ZM platform uses chemistry technology to develop
novel Ribosome Modulating Agents to target the human ribosome to
develop new potential therapeutics. Ribosomes form the translation
machinery that generates functional proteins from genetic
sequences; modulating the ribosome subunits provides a therapeutic
approach to address a number of different diseases.
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.
About Almirall
Almirall is a global pharmaceutical company
dedicated to medical dermatology. We closely collaborate with
leading scientists, healthcare professionals, and patients to
deliver our purpose: to transform the patients' world by helping
them realize their hopes and dreams for a healthy life. We are at
the forefront of science to deliver ground-breaking, differentiated
medical dermatology innovations that address patients´
needs.
Almirall, founded in 1944 and headquartered in
Barcelona, is publicly traded on the Spanish Stock Exchange
(ticker: ALM). Almirall (total revenue in 2023: €898.8 MM, 1900
employees globally) has a direct presence in 21 countries and
affiliates in over 70 others.
For more information, please
visit almirall.com
Corporate Communications contact Almirall: |
Investors’ Relations contact |
Corporate communications team |
Pablo Divasson del Fraile |
corporate.communication@almirall.com |
investors@almirall.com |
Phone: (+34) 659 614 173 |
Phone: (+34) 93 291 30 87 |
|
|
Eloxx Contacts: |
|
Investors: |
|
John Woolford |
|
john.woolford@westwicke.com |
|
443.213.0506 |
|
|
|
Media: |
|
Laureen Cassidy |
|
laureen@outcomescg.com |
|
|
|
Eloxx 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 and the expected timeline for clinical
development and efficacy of ZKN-013 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, or our 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 our, and our licensees’
preclinical studies and clinical trials and other research and
development activities; the competition for patient enrollment from
drug candidates in development;; 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 financing in the future
through product licensing, public or private equity or debt
financing or otherwise; our ability to meet the continued listing
requirements of the Nasdaq Capital Market; 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 September 30, 2023, 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/financials-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.
Almirall Legal warningThis
document includes only summary information and is not intended to
be exhaustive. The facts, figures and opinions contained in this
document, in addition to the historical ones, are "forward-looking
statements". These statements are based on the information
currently available and the best estimates and assumptions that the
Company considers reasonable. These statements involve risks and
uncertainties beyond the control of the Company. Therefore, actual
results may differ materially from those declared by such
forward-looking statements. The Company expressly waives any
obligation to revise or update any forward-looking statements,
goals or estimates contained in this document to reflect any
changes in the assumptions, events or circumstances on which such
forward-looking statements are based, unless required by the
applicable law.
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