Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical
company developing a new class of complement-based medicines for
patients with classical complement-mediated autoimmune,
neurodegenerative and ophthalmic disorders, today presented results
from the ongoing ARCHER trial in patients with geographic atrophy
(GA), underscoring ANX007’s potentially distinct neuroprotective
mechanism of action and demonstration of consistent protection from
vision loss. Data were presented during an oral presentation
titled, “Treatment of Geographic Atrophy Secondary to Age-Related
Macular Degeneration with Intravitreal ANX007: Results of the
ARCHER Study,” at the American Society of Retina Specialists (ASRS)
2023 Annual Meeting taking place July 28 – August 1, 2023 in
Seattle.
“Notwithstanding recent advances in the field of geographic
atrophy, preservation of vision remains a central need for the
millions of people living with GA around the world,” said Jeffrey
S. Heier, M.D., director of the Retina Service and Retina
Research, Ophthalmic Consultants of Boston, and an
investigator in ARCHER. “The results from ARCHER demonstrated dose
and time dependent protection of visual function in GA across
multiple measures. I am excited by the potential of ANX007 and its
distinct neuroprotective mechanism of action, which could offer
physicians a chance to preserve vision in a broad population of
patients.”
Topline data reported in May 2023 showed that ANX007
demonstrated statistically significant, dose-dependent protection
from vision loss in patients with GA, measured by best corrected
visual acuity (BCVA) ≥15 letter loss, a widely accepted functional
endpoint. Protection from vision loss was also shown in additional
prespecified measures of visual function, including low luminance
visual acuity (LLVA) and low luminance visual deficit (LLVD).
Annexon conducted additional analyses to further evaluate the
effect of ANX007 treatment on BCVA and GA lesion area. Results
presented today at ASRS included:
- Risk reduction for BCVA ≥15 letter loss was maintained in a
more conservative analysis, in which events occurring at the last
single-point visit were excluded.
- ANX007’s impact on BCVA ≥15 letter loss was consistent across
patients’ baseline characteristics, including lesion size, lesion
location, multifocality and others, and was not driven by any one
patient subgroup.
- In addition to protection against ≥15 BCVA letter loss,
ANX007’s impact on BCVA ≥10 letter loss and BCVA ≥20 letter loss
demonstrated consistent, dose-dependent protection from vision
loss.
- Mean change in BCVA at month 12 was supportive of protection of
visual function in a dose-dependent manner.
- ANX007 was generally well-tolerated through month 12, with no
increase in CNV rates between the treated and sham arms and no
events of retinal vasculitis reported.
In addition, as part of an investor conference call taking place
Monday, July 31 at 1:30 p.m. PT / 4:30 p.m. ET, Annexon will share
additional analyses, including:
- While the primary endpoint of mean rate of change (slope) in GA
lesion area compared to sham at 12 months did not reach statistical
significance in the ARCHER trial, additional analyses showed that
ANX007’s effect on lesion size showed a trend toward greater effect
in the second six months of study for both treatment groups,
suggesting that ANX007’s impact on lesion growth may increase with
time.
- In a fellow-eye analysis, comparison of sham, monthly (EM) and
every-other-month (EOM) treatment groups in the subset of patients
with bilateral GA, a consistent dose-dependent trend for protection
against ≥15 BCVA letter loss at the 12-month time point was shown.
No protection was demonstrated in sham whereas a 74% reduction for
EM and 47% reduction for EOM was demonstrated against the
corresponding fellow eye groups.
- In a preliminary 6-month off-treatment analysis assessing
vision loss after ANX007 treatment was discontinued, the rate of
decline in patients with BCVA ≥15 letter loss in the treated groups
accelerated to parallel the decline in the sham group. Benefit
gained during therapy was maintained, but the groups progressed in
parallel once treatment ended, providing independent support of
ANX007’s beneficial impact while on treatment.
The six-month off-treatment follow-up period of the ARCHER trial
is ongoing, and Annexon plans to report final results following
study conclusion.
“We're encouraged by the breadth and depth of the ARCHER data,
which demonstrate robust, dose and time dependent preservation of
vision loss in the broad patient population as measured by clinical
assessments important to the healthcare community and patients,”
said Douglas Love, chief executive officer of Annexon. “Looking
ahead, our priority is to advance ANX007 in GA as efficiently as
possible, and we will meet with regulators later this year to
determine the optimal path forward.”
Conference Call InformationAnnexon management
will host a conference call, joined by Dr. Heier, on Monday, July
31, 2023 at 1:30 p.m. PT / 4:30 p.m. ET. The webcast and
accompanying slides will be available under the ‘Events &
Presentations’ section on the Investors & Media page at
www.annexonbio.com. A replay of the webcast will be archived on the
Annexon website for 30 days. Dial-in information for conference
participants may be obtained by registering for the event here.
ARCHER Trial DesignARCHER is a randomized,
multi-center, double-masked, sham-controlled Phase 2 clinical trial
comparing the safety and efficacy of ANX007 in patients with GA
secondary to age-related macular degeneration (AMD). The study
enrolled a total of 270 patients, stratified by GA lesion size,
location and choroidal neovascularization (CNV) in the fellow eye
at the time of enrollment. Patients had an average age of 80 years
and, importantly, were well balanced for baseline visual acuity
(BCVA between 58.3 and 58.5). Ninety-six percent of patients
enrolled were from the United States.
Patients were randomized to receive an intravitreal dose of 5mg
ANX007 monthly (n=89), 5mg ANX007 every other month (n=92) or sham
monthly or every other month (pooled n=89) for a treatment period
of 12 months, followed by a six-month off-treatment period. The
primary outcome measure of the study was the rate of change in GA
lesion growth (slope) from baseline as measured by fundus
autofluorescence (FAF) through 12 months for the study eye. The
study included multiple pre-specified visual function measures to
assess the effects of ANX007 on vision: change from baseline in
BCVA, change from baseline in low-luminance best corrected visual
acuity (LLVA) and change in baseline from low-luminance visual
acuity deficit (LLVD). Top line results from the study were
reported in May 2023.
About ANX007GA is a disease of vision loss
driven by the loss of photoreceptor cells, a type of neuron.
Annexon was founded on the discovery that C1q, the initiating
molecule of the classical complement cascade, is a driver of
neurodegenerative disease. C1q binds to synapses (neuronal
connections) in disease, triggering activation of the classical
complement cascade with immune cell recruitment, neuroinflammation,
synapse loss, and neuronal damage. In GA, C1q anchors classical
pathway activation on photoreceptor cell synapses and outer
segments to cause inflammation and photoreceptor cell loss.
Inhibiting C1q blocks all downstream components of the classical
cascade to protect synapses and photoreceptors, providing a unique
neuroprotective mechanism. Annexon’s neuroprotective mechanism is
distinct from inhibition of C3 or C5, which do not inhibit upstream
components of the classical cascade that contribute to
photoreceptor damage. Further, selective inhibition of the
classical cascade leaves the lectin and alternative complement
pathways in place for normal homeostatic and immune functions.
Preclinical models have demonstrated that inhibition of C1q
protected photoreceptor synapses and cells and importantly,
photoreceptor cell function.
About Geographic Atrophy Geographic atrophy
(GA), also known as atrophic age-related macular degeneration (AMD)
or dry AMD, has a genetic link to aberrant complement activity and
can lead to blindness caused by damaged and dying retinal cells. It
is estimated that one million people in the United States and five
million people globally suffer from GA.
About AnnexonAnnexon (Nasdaq: ANNX) is a
clinical-stage biopharmaceutical company seeking to bring
game-changing medicines to patients with classical
complement-mediated diseases of the body, brain and eye. The
classical complement pathway within the immune system, when
overactivated, drives inflammation in a host of autoimmune,
neurodegenerative and ophthalmic diseases. Annexon is advancing a
new class of complement medicines targeting the early classical
cascade and all downstream pathway components that contribute to
disease, while selectively preserving the beneficial immune
functions of other complement pathways. Annexon is rigorously
developing a pipeline of diversified product candidates across
multiple mid- to late-stage clinical trials, with clinical data
anticipated throughout 2023 and beyond.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. In some cases, you
can identify forward-looking statements by terminology such as
“aim,” “anticipate,” “assume,” “believe,” “contemplate,”
“continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,”
“intend,” “may,” “objective,” “plan,” “positioned,” “potential,”
“predict,” “seek,” “should,” “suggest,” “target,” “on track,”
“will,” “would” and other similar expressions that are predictions
of or indicate future events and future trends, or the negative of
these terms or other comparable terminology. All statements other
than statements of historical facts contained in this press release
are forward-looking statements. These forward-looking statements
include, but are not limited to, statements about: topline data
from the ARCHER trial of ANX007 in patients with GA; ANX007’s
distinct potential neuroprotective mechanism of action and
potential to provide protection from vision loss; the potential for
robust, dose and time dependent preservation of vision loss in the
broad patient population; continued development of ANX007; market
size; meeting with regulators to determine the optimal path
forward; plans to report final results following study conclusion;
the potential benefits from treatment with anti-C1q therapy; and
continuing advancement of the company’s portfolio. Forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties that could cause actual results and
events to differ materially from those anticipated, including, but
not limited to, risks and uncertainties related to: the ongoing
off-treatment follow-up portion of the ARCHER trial and final
results from the ARCHER trial; the company’s history of net
operating losses; the company’s ability to obtain necessary capital
to fund its clinical programs; the early stages of clinical
development of the company’s product candidates; the effects of
public health crises on the company’s clinical programs and
business operations; the company’s ability to obtain regulatory
approval of and successfully commercialize its product candidates;
any undesirable side effects or other properties of the company’s
product candidates; the company’s reliance on third-party suppliers
and manufacturers; the outcomes of any future collaboration
agreements; and the company’s ability to adequately maintain
intellectual property rights for its product candidates. These and
other risks are described in greater detail under the section
titled “Risk Factors” contained in the company’s Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q and the company’s
other filings with the SEC. Any forward-looking statements that the
company makes in this press release are made pursuant to the
Private Securities Litigation Reform Act of 1995, as amended, and
speak only as of the date of this press release. Except as required
by law, the company undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
The contents of the company’s website at www.annexonbio.com and
the webcast and accompanying slides accessible through the
company’s website are not incorporated by reference into this press
release.
Investor Contact:Chelcie ListerTHRUST Strategic
Communicationschelcie@thrustsc.com
Media Contact:Sheryl SeapyReal
Chemistry949-903-4750sseapy@realchemistry.com
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