Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced it has
acquired Zikani Therapeutics, Inc. in an all-stock transaction,
with the potential to create a leader in ribosomal RNA-targeted
therapies for treatment of rare diseases and oncology. Sumit
Aggarwal, previously the President and Chief Executive Officer of
Zikani, has been named President and Chief Executive Officer of
Eloxx, and Vijay Modur, M.D., Ph.D., who was Zikani’s Chief
Scientific and Medical Officer, has been named Eloxx’s Head of
Research and Development.
“With the strength of our ELX-02 program for cystic fibrosis,
this acquisition provides us with the opportunity to amplify the
potential of our innovative science by developing a new class of
therapies to treat diseases with limited to no treatment options
under the stewardship of leaders with a proven ability to translate
technology into treatments for patients,” said Tomer Kariv, Eloxx
Chairman.
“We are excited about the potential of ELX-02 and combining the
companies opens the door to build a leadership position in genetic
therapy by rapidly developing treatments that can restore
functional proteins in patients with nonsense mutations in their
RNA,” said Aggarwal. “The combined capabilities of Eloxx and Zikani
in chemistry, biology, regulatory and drug development, including
Zikani’s TURBO-ZMTM synthetic chemistry platform for designing
macrolide-based Ribosome Modulating Agents (RMAs), along with a
committed leadership team and talented employees, will further
accelerate our ability to impact the lives of those who have rare
diseases with the type of urgency and novel thinking that they
deserve,” added Aggarwal.
ELX-02 is currently in Phase 2 clinical trials in Cystic
Fibrosis (CF) patients affected by nonsense mutations in the cystic
fibrosis transmembrane conductance regulator (CFTR) gene. The
investigational therapy has shown strong activity across a full
range of mutations in CF preclinical models. In Phase 1 testing,
ELX-02 was generally well- tolerated and demonstrated high
bioavailability with consistent pharamacokinetics across both
single and multiple-dose studies.
“The Phase 2 trials are designed to validate the safety of
ELX-02 and assess its biological activity. We look forward to
completing enrollment in the first four treatment arms by mid-year
and reporting data from these treatment arms in the second half of
this year,” said Dr. Modur.
In addition to CF, the company plans to file an IND in 2022 for
what could potentially become the first oral therapy for protein
restoration for patients with nonsense mutations in Recessive
Dystrophic Epidermolysis Bullosa (RDEB) and Junctional
Epidermolysis Bullosa (JEB). RDEB is an incurable, extremely
painful and often fatal skin blistering condition caused by a lack
of collagen type VII that is estimated to affect more than 3,000
people worldwide. JEB is the most severe form of EB, with most
patients dying in infancy.
By extending the application of ribosomal RNA modulation to the
readthrough of nonsense mutations in tumor suppressor genes, the
company is also rapidly advancing preclinical research for familial
adenomatous polyposis (FAP), an inherited pre-cancerous colorectal
disease frequently caused by nonsense mutations in the adenomatous
polyposis coli (APC) gene.
Nonsense mutations cause approximately 10-12 percent of rare
inherited diseases. ELX-02 along with the TURBO-ZM™ library of
compounds are anticipated to significantly expand to include the
treatment of many other rare diseases and certain cancers.
Acquisition Terms
Under the terms of the merger agreement, stockholders of Zikani
received approximately 7.6 million Eloxx common shares and own
approximately 16 percent of the combined company.
Board and Management Changes
In connection with the acquisition, Silvia Noiman, Ph.D., and
Martijn Kleijwegt have stepped down from the Eloxx Board. Alan
Walts, Ph.D., and Raj Parekh, Ph.D., who have both served as Zikani
directors, were appointed to fulfill the vacancies and serve out
the remaining terms of office.
“We’re pleased to welcome Sumit and Vijay to the Eloxx
leadership team. They demonstrated their ability to transform
Zikani by following the science and pursuing the creation of a new
class of therapies on behalf of patients with unmet medical need.
We want to extend our thanks and appreciation to Dr. Greg Williams
for his stewardship of Eloxx and his commitment to advancing the
critical work of the company. We are pleased that Greg will
continue to advise Eloxx to facilitate a smooth transition,” said
Kariv.
Conference Call Information
Date: Thursday, April 1, 2021
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866)
913-8546
International Dial-in Number: (210)
874-7715
Conference ID: 8180169
Live Webcast: accessible from the
Company's website at www.eloxxpharma.com under Events and
Presentations or by clicking here. A replay of this conference call
will be available on the Eloxx and Zikani websites.
Leadership Profiles
Sumit Aggarwal
Sumit Aggarwal served as Zikani’s President and CEO. He has led
the transformation of Zikani from an early-stage technology company
to a development-stage rare disease and oncology-focused
organization. Under Aggarwal’s leadership, Zikani has concentrated
its focus on demonstrating pre-clinical proof of efficacy across
several disease states using its TURBO-ZM™ technology platform.
In his more than 20 years in pharmaceutical and biotechnology
commercial operations, investment management and management
consulting, Aggarwal has been successful in transforming companies
by re-invigorating innovation, growth and profitability, and
raising capital for promising technology companies.
Prior to joining Zikani, he reinvigorated growth and
profitability at Progenity, raised $125 million in capital and
built a novel drug delivery-based GI pipeline. He also held
leadership roles in healthcare and biotechnology at Adage Capital
and as an Associate Partner at McKinsey & Company in its
healthcare practice.
Aggarwal has an MBA with distinction from the Johnson School,
Cornell University, and a Bachelor of Technology with Honors in
Chemical Engineering from the Indian Institute of Technology,
Kharagpur.
Vijay Modur, M.D., Ph.D.
Vijay Modur, M.D., Ph.D., served as Zikani’s Chief Scientific
and Medical Officer and has led the scientific efforts to transform
medicines based on ribosomal modulation using Zikani’s proprietary
TURBO-ZM™ technology platform.
In his more than 20 years in pharmaceutical and diagnostic roles
in R&D, he has successfully translated research discovery
efforts into products that have impacted medical practice.
Prior to joining Zikani, Dr. Modur led the venglustat rare
disease program at Sanofi across multiple rare disease indications
into Phase 2 and Phase 3 clinical development along with leading
other early development programs. Prior to Sanofi, he held
leadership roles in HTG Molecular, Novartis Oncology and Merck
Research Labs.
Dr. Modur obtained his MBBS from Karnatak University and his
Ph.D. from the University of Utah. He was a resident in Clinical
Pathology at Washington University School of Medicine where he also
completed his post-doctoral fellowship.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company developing novel RNA-modulating drug
candidates (designed to be eukaryotic ribosomal selective
glycosides) that are formulated to treat rare and ultra-rare
premature stop codon diseases. Premature stop codons are point
mutations that disrupt protein synthesis from messenger RNA. As a
consequence, patients with premature stop codon diseases have
reduced or eliminated protein production from the mutation bearing
allele accounting for some of the most severe phenotypes in these
genetic diseases. These premature stop codons have been identified
in over 1,800 rare and ultra-rare diseases.
Read-through therapeutic development is focused on extending
mRNA half-life and increasing protein synthesis by enabling the
cytoplasmic ribosome to read through premature stop codons to
produce full-length proteins. 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
the early stages of clinical development focusing on cystic
fibrosis. ELX-02 is an investigational drug that has not been
approved by any global regulatory body. Eloxx’s preclinical
candidate pool consists of a library of novel drug candidates
designed to be eukaryotic ribosomal selective glycosides identified
based on readthrough potential. Eloxx also has preclinical programs
focused on kidney diseases including autosomal dominant polycystic
kidney disease, as well as rare ocular genetic disorders. Eloxx is
headquartered in Waltham, MA, with operations in
Rehovot, Israel, and Morristown, NJ. For more
information, please visit www.eloxxpharma.com.
About Zikani Therapeutics
Zikani Therapeutics is an emerging leader in the science of
ribosome modulation, leveraging its innovative
TURBO-ZM™ chemistry technology platform to develop novel
Ribosome Modulating Agents (RMAs) as therapeutics for people with
limited treatment options. Zikani’s TURBO-ZM™ platform allows
rapid synthesis of novel compounds that can be optimized to
modulate the ribosome in a disease specific manner. As the company
evolves its focus from early-stage to clinical-stage research,
Zikani is actively moving into pre-clinical development to target
select rare diseases including inherited diseases and cancers
caused by nonsense mutations. For more information, visit
zikani.com.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, including: the development of the Company’s readthrough
technology; the approval of the Company’s patent applications; the
Company’s ability to successfully defend its intellectual property
or obtain necessary licenses at a cost acceptable to the Company,
if at all; the successful implementation of the Company’s research
and development programs and collaborations; the Company’s ability
to obtain applicable regulatory approvals for its current and
future product candidates; the acceptance by the market of the
Company’s products should they receive regulatory approval; the
timing and success of the Company’s preliminary studies,
preclinical research, clinical trials, and related regulatory
filings; the ability of the Company to consummate additional
financings as needed; the impact of global health concerns, such as
the COVID-19 global pandemic, on our ability to continue our
clinical and preclinical programs and otherwise operate our
business effectively, including successfully integrating the
combined companies; as well as those discussed in more detail in
our Annual Report on Form 10-K and our other reports filed with
the Securities and Exchange Commission.
Contact
InvestorsJohn
Woolfordjohn.woolford@westwicke.com443.213.0506
MediaLaureen Cassidylaureen@outcomescg.com
SOURCE: Eloxx Pharmaceuticals, Inc.
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