AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced positive top-line results from its global GEMINI-1
and GEMINI-2 Phase 3 trials evaluating the safety and efficacy of
investigational imsidolimab (IL-36R mAb) in patients with
generalized pustular psoriasis (GPP), a severe orphan disease that
is potentially life-threatening if left untreated.
In the 45-patient GEMINI-1 Phase 3 trial, patients were
randomized 1:1:1 to receive a single infusion of 750mg intravenous
(IV) imsidolimab, 300mg IV imsidolimab or placebo at Day 0. Of the
patients who received a single dose of 750mg IV imsidolimab, 53%
achieved a GPP Physician Global Assessment (GPPPGA) score of 0/1
(clear or almost clear skin) at Week 4 (primary endpoint), compared
to 13% of the patients on placebo (p=0.0131). Of the patients who
received a single dose of 300mg IV imsidolimab, 53% achieved GPPPGA
0/1 at Week 4.
Sixteen GPPPGA 0/1 responder patients from GEMINI-1 were
subsequently re-randomized to monthly maintenance dosing of either
200mg subcutaneous (SC) imsidolimab or placebo in the GEMINI-2
Phase 3 trial. Patients were followed for at least 24 weeks and up
to a maximum of 92 weeks. Of the eight responding patients from
GEMINI-1 who were re-randomized to monthly 200mg SC imsidolimab
maintenance therapy, 100% maintained a GPPPGA score of 0/1 and none
of them experienced a flare. Of the remaining eight responding
patients from GEMINI-1 who were re-randomized to placebo, 25%
maintained a GPPPGA score of 0/1 and 63% experienced a flare.
“The success of the GEMINI-1 and GEMINI-2 Phase 3 trials
highlights Anaptys’ ability to internally discover and develop
differentiated antibodies that deliver meaningful outcomes for
patients,” said Daniel Faga, president and chief executive officer
of Anaptys. “The results of these modestly sized studies reinforce
that only one single IV dose of imsidolimab was required to achieve
rapid clearance of GPP through four weeks and maintained in
patients receiving a monthly SC maintenance dose. We remain intent
on out-licensing imsidolimab to bring this therapy to patients
living with this highly morbid condition.”
Imsidolimab Well Tolerated Through End of
Study
Data from both trials demonstrate a consistent, favorable safety
and tolerability profile with no treatment-related serious adverse
events (SAEs) or SAEs leading to discontinuation reported in
imsidolimab-treated patients.
Additionally, the data show:
- Low incidence and no elevation of
infections versus placebo
- No cases reported of Drug Reaction
with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre
syndrome (GBS)
- No infusion reactions reported
- Overall incidence of anti-drug
antibodies (ADA) was low and, when detected, determined to be
non-neutralizing
Next Steps with GEMINI-1 and GEMINI-2
Trials
Anaptys plans to submit a comprehensive data abstract for
GEMINI-1 and GEMINI-2 results to a H2 2024 medical meeting.
With all patients having passed 24 weeks and the furthest
patient being treated through 92 weeks, the company is concluding
the GEMINI-2 trial. The company plans to out-license imsidolimab in
2024, and a potential future filing of a biologics license
application (BLA) with the U.S. Food and Drug Administration (FDA)
will be contingent on an out-licensing transaction.
“We’re immensely grateful to all the study investigators, study
staff and trial participants who helped evaluate this potential new
treatment option for GPP,” said Paul Lizzul, M.D., Ph.D., chief
medical officer of Anaptys. “We’re pleased that we have generated
clinically meaningful data to support a potential future regulatory
submission.”
GEMINI-1 and GEMINI-2 Trial Designs
Anaptys’ first Phase 3 GEMINI-1 clinical trial was a four week,
double-blind, placebo-controlled, randomized study to evaluate the
efficacy and safety of imsidolimab 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.
The objective of the GEMINI-2 trial was to assess the safety and
efficacy of imsidolimab for maintenance of response, and the
prevention of GPP flares with monthly SC dosing. A total of 42
patients were subsequently re-randomized into GEMINI-2. The 16
GPPPGA 0/1 responder patients from GEMINI-1 were re-randomized 1:1
to receive either monthly SC maintenance therapy of 200mg
imsidolimab or placebo.
About imsidolimab 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 for
autoimmune and inflammatory disease: ANB032, its BTLA agonist, in a
Phase 2b trial for the treatment of atopic dermatitis and
rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment
of rheumatoid arthritis and in a Phase 2 trial for the treatment of
ulcerative colitis. Its preclinical immune cell modulator portfolio
includes ANB033, an anti-CD122 antagonist antibody, and ANB101, a
BDCA2 modulator 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 that has completed Phase 3 trials for the
treatment of generalized pustular psoriasis, and etokimab, an
anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also
discovered multiple therapeutic antibodies licensed to GSK in a
financial collaboration for immuno-oncology, including an anti-PD-1
antagonist antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3
antagonist antibody (cobolimab, GSK4069889). To learn
more, visit www.AnaptysBio.com or follow us
on LinkedIn and X.
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 a presentation of Phase 3 clinical data
at a medical conference; whether imsidolimab will be approved by
regulatory authorities; and 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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