Allergan plc (NYSE: AGN), a leading global pharmaceutical company,
and Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing
company, today announced the Brilliance Phase 1/2 clinical trial of
AGN-151587 (EDIT-101) is open for patient enrollment. AGN-151587 is
an experimental medicine under development for the treatment of
Leber congenital amaurosis 10 (LCA10), an inherited form of
blindness caused by mutations in the CEP290 gene. The clinical
trial will be the world’s first in vivo study of a CRISPR-based
genome editing medicine, where the editing takes place inside the
human body.
“We are very proud of our continued commitment to developing
innovative treatments for unmet needs in eye care. Beginning
patient enrollment in the AGN-151587 clinical trial with our
partners at Editas is an important step toward our goal of
developing a game-changing, transformative, CRISPR-based medicine
for people with LCA10,” said David Nicholson, Ph.D., Chief Research
and Development Officer, Allergan.
The Brilliance clinical trial is a Phase 1/2 study to evaluate
AGN-151587 for the treatment of LCA10. The study will assess
safety, tolerability, and efficacy in approximately 18 patients. Up
to five cohorts across three dose levels will be enrolled in this
open label clinical trial in multiple centers. Both adult and
pediatric patients (3 – 17 years old) with a range of vision will
be evaluated. Patients will receive a single dose of AGN-151587
administered via subretinal injection in one eye following
vitrectomy. Additional details are available on
www.clinicaltrials.gov (NCT#03872479).
“Now that enrollment is underway, we are one step closer to
delivering a transformative medicine to LCA10 patients,” said
Charles Albright, Ph.D., Chief Scientific Officer, Editas Medicine.
“The team at Editas looks forward to continuing to collaborate with
our partners at Allergan, patient advocacy organizations, and the
inherited retinal diseases community as we develop this and other
durable experimental medicines for patients with devastating ocular
diseases.”
Sites in the U.S. are currently enrolling patients for the
trial, including Massachusetts Eye and Ear, an international center
for treatment and research and a teaching hospital of Harvard
Medical School.
“Today marks an important day for the inherited retinal disease
community, and specifically those affected by LCA10. We are very
excited to have another potentially life changing medicine enter
the clinic and join Allergan and Editas in celebrating this
milestone,” said Ben Yerxa, Ph.D., CEO, Foundation Fighting
Blindness.
About AGN-151587 (EDIT-101)AGN-151587
(EDIT-101) is a CRISPR-based experimental medicine under
investigation for the treatment of Leber congenital amaurosis 10
(LCA10). AGN-151587 is administered via a subretinal injection to
reach and deliver the gene editing treatment directly to
photoreceptor cells.
About Leber Congenital AmaurosisLeber
congenital amaurosis, or LCA, is a group of inherited retinal
degenerative disorders caused by mutations in at least 18 different
genes. It is the most common cause of inherited childhood
blindness, with an incidence of two to three per 100,000 live
births worldwide. Symptoms of LCA appear within the first
years of life, resulting in significant vision loss and potentially
blindness. The most common form of the disease, LCA10, is a
monogenic disorder caused by mutations in the CEP290 gene and is
the cause of disease in approximately 20‑30 percent of all LCA
patients.
About the Editas Medicine-Allergan AllianceIn
March 2017, Editas Medicine and Allergan Pharmaceuticals
International Limited (Allergan) entered a strategic alliance and
option agreement under which Allergan received exclusive access and
the option to license up to five of Editas Medicine’s genome
editing programs for ocular diseases, including AGN-151587
(EDIT-101). Under the terms of the agreement, Allergan is
responsible for development and commercialization of optioned
products, subject to Editas Medicine’s option to co-develop and
share equally in the profits and losses of two optioned products in
the United States. In August 2018, Allergan exercised its
option to develop and commercialize AGN-151587 globally for the
treatment of LCA10. Additionally, Editas Medicine exercised its
option to co-develop and share equally in the profits and losses
from AGN-151587 in the United States. Editas Medicine is also
eligible to receive development and commercial milestones, as well
as royalty payments on a per-program basis. The agreement
covers a range of first-in-class ocular programs targeting serious,
vision-threatening diseases based on Editas Medicine’s unparalleled
CRISPR genome editing platform, including CRISPR/Cas9 and
CRISPR/Cpf1 (also known as Cas12a).
About Allergan plcAllergan plc (NYSE: AGN),
headquartered in Dublin, Ireland, is a global pharmaceutical leader
focused on developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations
located in approximately 100 countries, Allergan is committed to
working with physicians, healthcare providers and patients to
deliver innovative and meaningful treatments that help people
around the world live longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
About Editas Medicine As a
leading genome editing company, Editas Medicine is
focused on translating the power and potential of the CRISPR/Cas9
and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into
a robust pipeline of treatments for people living with serious
diseases around the world. Editas Medicine aims to
discover, develop, manufacture, and commercialize transformative,
durable, precision genomic medicines for a broad class of diseases.
For the latest information and scientific presentations, please
visit www.editasmedicine.com.
Allergan Forward-Looking StatementsStatements
contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that
reflect Allergan’s current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan’s current expectations depending
upon a number of factors affecting Allergan’s business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan’s products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated with
divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan’s periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018 and Allergan's Quarterly
Report on Form 10-Q for the period ended March 31, 2019. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
Editas Medicine Forward-Looking StatementsThis
press release contains forward-looking statements and information
within the meaning of The Private Securities Litigation Reform Act
of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’
‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’
‘‘would,’’ and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include statements regarding
Editas Medicine’s plans with respect to the Phase 1/2 clinical
trial for AGN-151587 (EDIT-101). Editas Medicine may not
actually achieve the plans, intentions, or expectations disclosed
in these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results
or events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various factors, including: uncertainties inherent in the
initiation and completion of preclinical studies and clinical
trials and clinical development of Editas Medicine’s product
candidates; availability and timing of results from preclinical
studies and clinical trials; whether interim results from a
clinical trial will be predictive of the final results of the trial
or the results of future trials; expectations for regulatory
approvals to conduct trials or to market products and availability
of funding sufficient for Editas Medicine’s foreseeable and
unforeseeable operating expenses and capital expenditure
requirements. These and other risks are described in greater
detail under the caption “Risk Factors” included in Editas
Medicine’s most recent Annual Report on Form 10-Q, which is on file
with the Securities and Exchange Commission, and in other filings
that Editas Medicine may make with the Securities and Exchange
Commission in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Editas Medicine expressly disclaims any obligation to update
any forward-looking statements, whether because of new information,
future events or otherwise.
Contacts: |
|
Allergan:
|
Editas
Medicine: |
Investors:
|
Investors: |
Manisha Narasimhan,
Ph.D. |
Mark Mullikin |
(862) 261-7162
|
(617) 401-9083 |
manisha.narasimhan@allergan.com |
mark.mullikin@editasmed.com |
|
Media:
|
Media: |
Fran DeSena
|
Cristi Barnett |
(862) 261-8820
|
(617) 401-0113 |
frances.desena@allergan.com |
cristi.barnett@editasmed.com |
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