AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced positive top-line results from its global Phase 3
GEMINI-1 trial evaluating the safety and efficacy of imsidolimab
(IL-36R mAb) in patients with generalized pustular psoriasis (GPP)
flares. Investigational imsidolimab met its primary endpoint in the
study population achieving rapid clearance of pustulation, erythema
and scaling through Week 4 after a single dose of 750mg IV
imsidolimab. Top-line data also demonstrate a favorable safety and
tolerability profile.
“The success of the GEMINI-1 trial highlights Anaptys’
commitment to patients and our ability to internally discover and
develop differentiated antibodies,” said Daniel Faga, president and
chief executive officer of Anaptys. “Moving forward, we intend to
out-license imsidolimab with this compelling and competitive
dataset to bring this therapy to patients living with this highly
morbid condition and reallocate the potential proceeds of a
transaction to further invest in the broad development of our
best-in-class immune cell modulators, including our checkpoint
agonists, in autoimmune and inflammatory diseases.”
Imsidolimab is an IgG4 antibody that inhibits the function of
the interleukin-36 receptor (IL-36R), a signaling pathway within
the immune system shown to be involved in the pathogenesis of
inflammatory diseases, including GPP. The registration-enabling
GEMINI-1 trial in GPP, which recruited 45 patients, is the first
randomized, double-blind, placebo-controlled trial to use the
composite endpoint of Generalized Pustular Psoriasis Physician
Global Assessment (GPPPGA) at Week 4 as its primary assessment. The
GPPPGA assessment, representing a stringent and comprehensive
characterization of disease severity, required satisfying an
overall clinical response score of 0/1 (clear or almost clear)
collectively across each GPP disease attribute, including
pustulation, erythema and scaling.
“GPP is an unpredictable and potentially life-threatening skin
disease with systemic symptoms,” said Professor Hervé Bachelez,
M.D., Ph.D., Hôpital Saint-Louis, Paris, one of the world’s leading
experts on GPP. “Achieving positive top-line results utilizing the
GPPPGA composite endpoint in this well conducted, randomized
controlled, global trial, along with a compelling safety profile,
represents the potential for a single dose of imsidolimab to
predictably provide relief for patients living with this burdensome
disease.”
Imsidolimab Met Primary Endpoint Achieving Rapid
Clearance of GPP Through Week 4 After a Single Dose
53.3% of patients who received a single dose of 750mg IV
imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4
(primary endpoint), compared to 13.3% of patients on placebo
(p=0.0131).
Additionally, 66.7% (10/15) of placebo patients exited GEMINI-1
early, crossed-over to GEMINI-2 and were eligible to receive rescue
therapy with a single dose of 750mg IV imsidolimab.
Imsidolimab Was Well Tolerated Through End of
Study
- All AEs reported in
imsidolimab-treated patients were mild or moderate and balanced
across imsidolimab-treated vs. placebo patients
- No SAEs or severe AEs reported in
imsidolimab-treated patients
- No cases reported of Drug Reaction
with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre
syndrome (GBS)
- Low incidence and no elevation of
infections vs. placebo
- No infusion reactions reported
- One of 30 (3.3%) imsidolimab-treated
patients had detectable anti-drug antibodies, which were
non-neutralizing
Anaptys plans to present comprehensive data from GEMINI-1 and
top-line GEMINI-2 results at a medical meeting in H2 2024.
Furthermore, the company anticipates filing a biologics license
application (BLA) with the U.S. Food and Drug Administration (FDA)
by Q3 2024.
“We are excited that these top-line results from the Phase 3
GEMINI-1 trial support that a single infusion of imsidolimab is
efficacious and well tolerated,” said Paul Lizzul, M.D., Ph.D.,
chief medical officer of Anaptys. “We would like to thank the
patients, investigators and study personnel for their participation
in this trial. We look forward to engaging with FDA and plan to
submit a BLA by Q3 2024.”
GEMINI-1 Trial Design and Patient
Demographics
Anaptys’ Phase 3 registration-enabling GEMINI-1 clinical trial
was a four week, double-blind, placebo-controlled, randomized study
to evaluate the efficacy and safety of imsidolimab (IL-36R) in
patients with GPP, irrespective of mutational status.
A total of 45 patients, 15 patients per arm, were enrolled
across diverse global regions ranging from the U.S., EU, MENA, and
Asia. Patients were randomized 1:1:1 to receive a single infusion
of 750mg IV imsidolimab, 300mg IV imsidolimab or placebo at Day 0.
Placebo patients who were worsening or not improved after Day 8
were eligible for rescue therapy and crossover into the GEMINI-2
Phase 3 trial where they received a single infusion of 750mg IV
imsidolimab.
GEMINI-2 Trial Design
Patients who were rescued or completed the GEMINI-1 trial are
subsequently being enrolled in GEMINI-2, the second Phase 3 trial
for imsidolimab in GPP, where they are receiving monthly doses of
200mg subcutaneous imsidolimab or placebo depending upon whether
they are responders, partial responders or non-responders to
treatment under GEMINI-1.
The objective of the ongoing GEMINI-2 trial is to assess the
efficacy and safety of imsidolimab for the prevention and/or
reduction in severity of recurrent GPP flares when dosed
chronically as a monthly subcutaneous dosing over a three-year
period.
About imsidolimab (IL-36R) and GPP
Imsidolimab is a fully humanized IgG4 antibody that inhibits the
function of the interleukin-36-receptor, or IL-36R, that is being
developed for the treatment of GPP.
GPP is a rare, chronic, systemic autoinflammatory disease that
is potentially life-threatening, if left untreated.
During a GPP flare, individuals experience the sudden eruption
of painful pustules. These pustules appear over large areas of the
skin, accompanied by redness, severe itchiness, and dry, cracked,
or scaly skin. People with GPP may also experience more general
symptoms such as fever, headache, extreme tiredness, or a burning
sensation on the skin.
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics. It is developing
immune cell modulators, including two checkpoint agonists in
clinical-stage development, for autoimmune and inflammatory
disease: rosnilimab, its PD-1 agonist, in a Phase 2b trial for the
treatment of moderate-to-severe rheumatoid arthritis; and ANB032,
its BTLA agonist, in a Phase 2b trial for the treatment of
moderate-to-severe atopic dermatitis. Its preclinical immune cell
modulator portfolio includes ANB033, an anti-CD122 antagonist
antibody for the treatment of autoimmune and inflammatory diseases.
In addition, Anaptys has developed two cytokine antagonists
available for out-licensing: imsidolimab, an anti-IL-36R
antagonist, in Phase 3 for the treatment of generalized pustular
psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the
treatment of respiratory disorders that is Phase 2/3 ready. Anaptys
has also discovered multiple therapeutic antibodies licensed to GSK
in a financial collaboration for immune-oncology, including an
anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an
anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an
anti-LAG-3 antagonist antibody (GSK4074386).
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 imsidolimab’s Phase 3 GEMINI-2 clinical
trial in GPP; the timing of GEMINI-1 and GEMINI-2 clinical trial
data to be presented at a medical meeting; the timing of a BLA
filing for imsidolimab; whether any of the Company’s product
candidates will be best in class; the company’s ability to find a
licensing partner for imsidolimab or etokimab and the timing of any
such transaction. Statements including words such as “plan,”
“intend,” “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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