Allergan plc (NYSE: AGN), a leading global pharmaceutical company,
and Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing
company, today announced the treatment of the first patient in the
BRILLIANCE clinical trial of AGN-151587 (EDIT-101) at Oregon Health
& Science University (OHSU) Casey Eye Institute, a
world-recognized academic eye center.
AGN-151587 (EDIT-101) is an experimental medicine delivered via
sub-retinal injection under development for the treatment of Leber
congenital amaurosis 10 (LCA10), an inherited form of blindness
caused by mutations in the centrosomal protein 290 (CEP290) gene.
The BRILLIANCE clinical trial is a Phase 1/2 study to evaluate
AGN-151587 for the treatment of patients diagnosed with LCA10 and
is the world’s first human study of an in vivo, or inside the body,
CRISPR genome editing medicine. The trial will assess the safety,
tolerability, and efficacy of AGN-151587 in approximately 18
patients with LCA10.
“This dosing is a truly historic event – for science, for
medicine, and most importantly for people living with this eye
disease,” said Cynthia Collins, President and CEO, Editas Medicine.
“The first patient dosed in the BRILLIANCE clinical trial marks a
significant milestone toward delivering on the promise and
potential of CRISPR medicines to durably treat devastating diseases
such as LCA10. We look forward to sharing future updates from this
clinical trial and our ocular program.”
“Currently patients living with LCA10 have no approved treatment
options. For years, Allergan has had an
unwavering commitment to advancing eye care
treatments. With the first patient treated in this historic
clinical trial, we mark a significant step in advancing the
AGN-151587 clinical program and move closer to our goal of
developing a game-changing medicine for LCA10 patients,” said Brent
Saunders, Chairman and CEO, Allergan.
“Our first treatment in this clinical trial is an important step
toward bringing new and promising treatments to patients with
disease-causing gene mutations. OHSU is honored to be involved in
this effort to address previously untreatable diseases such as
Leber congenital amaurosis 10,” said Mark Pennesi, M.D., Ph.D.,
Associate Professor of Ophthalmology, Kenneth C. Swan Endowed
Professor, Division Chief, Paul H. Casey Ophthalmic Genetics, Casey
Eye Institute, Oregon Health & Science University, Principal
Investigator and enrolling physician of the first patient treated
with AGN-151587.
Eric A. Pierce, M.D., Ph.D., Director of the Inherited Retinal
Disorders Service and Director of the Ocular Genomics Institute at
Massachusetts Eye and Ear, and the William F. Chatlos Professor of
Ophthalmology at Harvard Medical School, and a Principal
Investigator for the BRILLIANCE clinical trial also commented, “We
have a long history at Massachusetts Eye and Ear of helping develop
life-changing medicines for our patients, and we are thrilled to be
a leader in the development of a CRISPR-based experimental medicine
to treat CEP290-associated retinal disease with Allergan and
Editas.”
About the BRILLIANCE Phase 1/2 Clinical Trial of
AGN-151587 (EDIT-101)The BRILLIANCE Phase 1/2 clinical
trial of AGN-151587 (EDIT-101) for the treatment of Leber
congenital amaurosis 10 (LCA10) will assess the safety,
tolerability, and efficacy of AGN-151587 in approximately 18
patients with this disorder. Up to five cohorts of patients across
three dose levels will be enrolled in this open label,
multi-center, clinical trial. Both adult and pediatric patients (3
– 17 years old) with a range of baseline visual acuity assessments
are eligible for enrollment. Patients will receive a single
administration of AGN-151587 via subretinal injection in one eye.
Additional details are available on www.clinicaltrials.gov
(NCT#03872479).
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
deliver the gene editing machinery 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. 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). 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.
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/Cas12a (also known as Cpf1) 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, 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 the
Companies’ 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-K, 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:Investors:Manisha Narasimhan,
Ph.D.(862) 261-7162manisha.narasimhan@allergan.com |
Editas Medicine:Investors:Mark Mullikin(617)
401-9083mark.mullikin@editasmed.com |
|
|
Media:Fran DeSena(862) 261 8820frances.desena@allergan.com |
Media: Cristi Barnett(617)
401-0113cristi.barnett@editasmed.com |
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