ACELYRIN, INC. Announces Positive 16-week Data From its Global Phase 2b/3 Trial of Izokibep in Psoriatic Arthritis to be Shared During Late-Breaking Oral Presentation at EULAR 2024
05 Juni 2024 - 1:00PM
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
positive results from the company’s global Phase 2b/3 clinical
trial of izokibep in psoriatic arthritis (PsA) will be shared as a
late breaking oral presentation at the 2024 European Alliance of
Associations for Rheumatology Congress taking place June 12-15 in
Vienna, Austria. Izokibep is a small protein therapeutic designed
to inhibit IL-17A, a validated mechanism for the treatment of PsA
and other immune-mediated diseases.
Presentation details are as follows:
Title: Efficacy and Safety of Izokibep, a Novel IL-17A
Inhibitor, in Patients with Active Psoriatic Arthritis: Week 16
Results from a Randomized, Double-Blind, Placebo-Controlled,
Multicenter Phase 2b/3 StudyDate/Time: Saturday, June 15,
2024; 9:30am - 9:40am CESTPresenter: Philip Mease, MD, MACR,
Director of Rheumatology Research at Swedish Medical Center
About the Phase 2b/3 Psoriatic Arthritis clinical
trialThe Phase 2b/3 clinical trial (NCT05623345) is a
global, multi center, randomized double-blind, placebo-controlled
trial evaluating the safety and efficacy of izokibep dosed
subcutaneously 160 mg every week (QW) or every two weeks (Q2W) and
80 mg every four weeks (Q4W) versus placebo. 351 adult patients
with active PsA were enrolled across 71 sites in the United States
and Europe and randomized across the four arms.
For more information about the Phase 2b/3 PsA clinical trial,
please visit www.clinicaltrials.gov.
About Psoriatic ArthritisPsoriatic arthritis
(PsA) is a chronic immune-mediated inflammatory disease
characterized by multiple manifestations including destructive
joint inflammation, psoriasis, and enthesitis (painful inflammation
of the small, dense tissues that connect ligament and tendons to
bone), all contributing to reduced quality of life. It is estimated
that approximately 30% of the 125 million people living with
psoriasis worldwide will also develop PsA over time. There remains
a large unmet need for more effective therapies to treat PsA across
all disease manifestations.
About IzokibepIzokibep is a small protein
therapeutic designed to inhibit IL-17A with high potency through
tight binding affinity, providing the potential for robust tissue
penetration due to its small molecular size, about one-tenth the
size of a monoclonal antibody, and an albumin binding domain that
extends half-life. Clinical trial data supports the hypothesis that
these unique characteristics of izokibep may provide clinically
meaningful and differentiated benefits for patients, including
resolution of key manifestations of disease. Izokibep is being
evaluated in multiple late-stage trials in moderate-to-severe
hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and
uveitis, with plans to initiate an additional Phase 3 program in
axial spondyloarthritis (AxSpA).
About ACELYRIN, INC.ACELYRIN, INC. (Nasdaq:
SLRN) is a Los Angeles area-based late-stage clinical biopharma
company – with additional operations in the San Francisco Bay area
– focused on providing patients life-changing new treatment options
by identifying, acquiring, and accelerating the development and
commercialization of transformative medicines. ACELYRIN has two
programs in late-stage clinical development. Lonigutamab is a
subcutaneously delivered monoclonal antibody targeting IGF-1R
advancing into Phase 2b/3 development for the treatment of thyroid
eye disease. Izokibep is a next generation inhibitor of IL-17A in
Phase 2b/3 development for the treatment of psoriatic arthritis,
hidradenitis suppurativa and uveitis.
For more information about ACELYRIN, visit us at
www.acelyrin.com or follow us on LinkedIn and X.
Forward Looking Statements This press release
contains forward-looking statements including, but not limited to,
statements related to the potential future success of ACELYRIN’s
izokibep program; anticipated development activities including the
planned initiation and timing of clinical trials; the therapeutic
potential of ACELYRIN’s product candidates, including the ability
for such product candidates to offer clinically meaningful,
differentiated benefits including resolution of key manifestations
of disease, and including clinical benefits that may improve over
time; 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 ACELYRIN’s
product candidates; the timing and results of ACELYRIN’s clinical
trials, including the risk that future clinical trial results could
differ materially and adversely from prior clinical trial results
or data; maintaining and defending intellectual property
protection; delays or failures to secure adequate supply of its
product candidates; ACELYRIN’s failure to realize the expected
benefits of its acquisition of additional programs; legal
proceedings 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 March 31, 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,Communications and
Advocacyinvestors@acelyrin.com media@acelyrin.com
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