ACELYRIN, INC. Announces Topline Results From Phase 2b/3 Study of Izokibep for the Treatment of Uveitis
2024年12月11日 - 6:30AM
ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma
company focused on accelerating the development and delivery of
transformative medicines in immunology, today announced that its
Phase 2b/3 trial of izokibep in non-infectious, non-anterior
uveitis did not meet the primary endpoint of a statistically
significant improvement in time to treatment failure versus placebo
as measured by treatment failure rates at 24 weeks. Based on these
data, and previously announced guidance regarding other
indications, ACELYRIN will not make any additional internal
investment in developing izokibep. ACELYRIN will continue to focus
on executing its late-stage development program for lonigutamab in
thyroid eye disease (TED).
“We are very grateful to all the patients, families and clinical
investigators for their time and effort put into this trial, and,
like them, we are disappointed that it did not meet its primary
endpoint,” said Mina Kim, Chief Executive Officer of
ACELYRIN. “Consistent with our previously announced pipeline
prioritization strategy, we will continue to focus on advancing
subcutaneous lonigutamab for patients with thyroid eye disease. We
look forward to hosting a lonigutamab investor event in early 2025
and remain on track to initiate the Phase 3 program in the first
quarter of 2025. Given our strong balance sheet, we will also
continue evaluating selective and opportunistic pipeline expansion
opportunities.”
About the Phase 2b/3 Uveitis Clinical Trial and Topline
Results:The Phase 2b/3 clinical trial (NCT05683496)
evaluated izokibep versus placebo in non-infectious, non-anterior
uveitis. Patients in the study were randomized 1:1 to receive
weekly subcutaneous injections of izokibep 160 mg or placebo. The
primary endpoint of the study was improvement in time to treatment
failure versus placebo as measured by treatment failure rates at 24
weeks. Key secondary endpoints included measurement of the change
in best corrected visual acuity (BCVA), change in visual function
as measured by the National Eye Institute’s Visual Function
Questionnaire (VFQ25), % change in central retinal thickness (CRT)
as measured by Spectral-Domain Optical Coherence Tomography and
achievement of Quiescence.
In the trial, the treatment failure rate at 24 weeks was 45.0%
(p-value: 0.4914) for izokibep and 50.7% for placebo. Statistical
significance was not reached for any secondary endpoint and no
clinical benefit was observed. Izokibep was well-tolerated in the
trial, with a safety profile consistent with previous data and the
IL-17A class.
ACELYRIN’s revised operating plan in connection with the
announcement of the pipeline prioritization and corporate
restructuring on August 13, 2024 included the funding of two Phase
3 trials and BLA-enabling activities for lonigutamab, selective
pipeline expansion and the completion of the izokibep uveitis
trial. Consistent with that plan, there will be no organizational
or operational plan changes related to today’s announcement. The
Company continues to project that its existing cash resources will
provide runway to mid-2027.
About ACELYRIN, INC.ACELYRIN, INC. (Nasdaq:
SLRN) is focused on providing patients life-changing new treatment
options by identifying, acquiring, and accelerating the development
and commercialization of transformative medicines. ACELYRIN’s lead
program, lonigutamab, is a subcutaneously delivered monoclonal
antibody targeting IGF-1R being investigated for the treatment of
thyroid eye disease.
For more information about ACELYRIN, visit us
at www.acelyrin.com or follow us on LinkedIn and X.
Forward Looking StatementsThis press release
contains forward-looking statements including, but not limited to,
statements related to ACELYRIN’s expectations regarding its cash
runway and ability to fund several milestones; ACELYRIN’s ability
to accelerate the development and delivery of transformative
medicines in immunology; ACELYRIN’s plan to not make any additional
internal investment in developing izokibep and to focus on
executing its late-stage development program for lonigutamab in
TED; anticipated development activities including the planned
initiation of the lonigutamab Phase 3 program and the timing
thereof; the therapeutic potential of lonigutamab; the potential
expansion of ACELYRIN’s pipeline; and other statements that are not
historical fact. These forward-looking statements are based on
ACELYRIN’s current plans, objectives and projections, and are
inherently subject to risks and uncertainties that may cause
ACELYRIN’s actual results to materially differ from those
anticipated in such forward-looking statements. Such risks and
uncertainties include, without limitation, those associated with
the successful completion of development and regulatory activities
with respect to lonigutamab; maintaining and defending intellectual
property protection; delays or failures to secure adequate supply
of lonigutamab; ACELYRIN’s failure to realize the expected benefits
of its potential acquisition of additional programs; legal
proceedings, government investigations or other actions;
macroeconomic conditions; market volatility; and other risks and
uncertainties affecting ACELYRIN including those described from
time to time under the caption “Risk Factors” and elsewhere in
ACELYRIN’s current and future reports filed with the Securities and
Exchange Commission, including its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2024. Forward-looking
statements contained in this press release are made as of this
date, and ACELYRIN undertakes no duty to update such information
except as required under applicable law.
ACELYRIN Contacts:Tyler
MarciniakVice President of Investor Relations and Corporate
Operationsinvestors@acelyrin.commedia@acelyrin.com
ACELYRIN (NASDAQ:SLRN)
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