Anaptys Announces Phase 2b Trial of ANB032, a BTLA Agonist, Did Not Meet Primary or Secondary Endpoints in Atopic Dermatitis
11 Dezembro 2024 - 10:30AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced that investigational ANB032, a BTLA agonist, did
not meet the primary and secondary endpoints in any of the doses
studied in the global, 201-patient ARISE-AD trial as a monotherapy
for moderate-to-severe atopic dermatitis (AD) or eczema. ANB032 was
well tolerated with no safety signals observed.
“While ANB032 was safe and well tolerated, we’re disappointed by
these efficacy results in AD and will discontinue further
investment in this asset. Moving forward, our resources and capital
will be focused on the rest of our exciting autoimmune portfolio,”
said Daniel Faga, president and chief executive officer of Anaptys.
“PD-1 is a co-inhibitory receptor found preferentially on activated
T cells. We look forward to sharing for rosnilimab, a depleter and
agonist targeting PD-1+ T cells, top-line Phase 2b rheumatoid
arthritis data in February 2025 and top-line Phase 2 ulcerative
colitis data in Q1 2026, followed by Phase 1b data from our two
additional programs.”
The ARISE-AD study evaluated the efficacy, safety, tolerability,
pharmacokinetics and pharmacodynamics of ANB032 monotherapy in
patients with moderate-to-severe AD. The study enrolled 201
patients with a mean baseline EASI score of 27.3 in the U.S.,
Canada, Europe, Australia and New Zealand, who were either
biologics naïve (n=168) or biologics experienced (n=33), defined as
having received treatment with dupilumab or other IL-13 therapies.
Patients were randomized to receive for 12 weeks either 100mg of
subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks
(Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and
secondary endpoints were assessed at Week 14.
Regardless of prior treatment experience, ANB032 did not meet
the primary endpoint of the proportion of patients who achieved at
least a 75% improvement from baseline in Eczema Area and Severity
Index score (EASI-75), or any of the secondary endpoints at Week
14, including EASI-90, mean change in baseline EASI or a 4-point
reduction in itch severity as measured by the peak Pruritus
Numerical Rating Scale (PNRS) versus placebo.
Absolute response rates on key endpoints in patients treated
with ANB032 approached the minimum target product profile with
durable off-drug responses; however, higher placebo rates outside
of the historical norm, particularly in the U.S., were
observed.
ANB032 was well tolerated across all doses with no safety
signals observed. Consistent with prior studies, data demonstrate a
favorable safety and tolerability profile for ANB032, with one
participant across all three active dose arms with a serious
adverse event (SAE) of worsening AD and two placebo participants
with SAEs. There was no dose relationship or imbalance in AEs and
no safety signals observed. The most common (>5%) AEs observed
were nasopharyngitis, atopic dermatitis and headache.
“We are sincerely grateful to all of the patients and clinicians
who participated in this important trial, without whom we would not
be able to continue to learn about how best to treat this
debilitating chronic disease,” said Paul Lizzul, M.D., Ph.D., chief
medical officer of Anaptys.
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics for autoimmune and
inflammatory diseases. Its lead program, rosnilimab, a depleter and
agonist targeting PD-1+ T cells, in a Phase 2b trial for the
treatment of rheumatoid arthritis and in a Phase 2 trial for the
treatment of ulcerative colitis. Other antibodies in its portfolio
include ANB033, an anti-CD122 antagonist, in a Phase 1 trial and
ANB101, a BDCA2 modulator, soon to enter clinical development.
Anaptys has also discovered multiple therapeutic antibodies
licensed to GSK in a financial collaboration for immuno-oncology,
including an anti-PD-1 antagonist (Jemperli (dostarlimab-gxly)) and
an anti-TIM-3 antagonist (cobolimab, GSK4069889). To learn more,
visit www.AnaptysBio.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to: the timing of the release of data from the Company’s
clinical trials, including rosnilimab’s Phase 2b clinical trial in
rheumatoid arthritis and Phase 2 clinical trial in ulcerative
colitis; whether rosnilimab will be best-in-class; the potential to
receive any additional milestones and royalties from the GSK
collaboration; and the Company’s estimated year-end cash balance
and cash runway. Statements including words such as “plan,”
“continue,” “expect,” or “ongoing” and statements in the future
tense are forward-looking statements. These forward-looking
statements involve risks and uncertainties, as well as assumptions,
which, if they do not fully materialize or prove incorrect, could
cause its results to differ materially from those expressed or
implied by such forward-looking statements. Forward-looking
statements are subject to risks and uncertainties that may cause
the company’s actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties related to the company’s ability to advance
its product candidates, obtain regulatory approval of and
ultimately commercialize its product candidates, the timing and
results of preclinical and clinical trials, the company’s ability
to fund development activities and achieve development goals, the
company’s ability to protect intellectual property and other risks
and uncertainties described under the heading “Risk Factors” in
documents the company files from time to time with the Securities
and Exchange Commission. These forward-looking statements speak
only as of the date of this press release, and the company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date
hereof.
Contact:Nick MontemaranoSenior Director,
Investor Relations and Strategic Communications
858.732.0178investors@anaptysbio.com
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