AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP)
02 May 2023 - 11:15PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced the publication of data from the open-label,
single-arm Phase 2 GALLOP study evaluating the efficacy,
tolerability and safety of imsidolimab, its investigational
anti-interleukin-36 receptor (IL-36R) IgG4 antibody for the
treatment of generalized pustular psoriasis (GPP), in the British
Journal of Dermatology. Patients with GPP who received a single
dose of imsidolimab demonstrated a rapid and sustained improvement
of symptoms and pustular eruptions of GPP flare within days after
initiating treatment.
A potentially debilitating and life-threatening systemic
inflammatory skin disease, GPP affects an estimated 15,000 to
37,000 individuals in the U.S. It is characterized by intermittent
and/or recurrent episodes, or flares, of widespread pustular
eruptions that can be accompanied by fever, nausea, pain, anorexia
and general malaise.
“We remain excited and quite pleased with the dramatic effects
demonstrated by imsidolimab’s Phase 2 efficacy and safety data and
the potential benefit to patients suffering with life threatening
inflammatory GPP,” said Paul F. Lizzul, chief medical officer of
AnaptysBio. “We look forward to sharing the top-line data on the
efficacy, safety and tolerability of a single dose IV infusion of
imsidolimab in moderate-to-severe GPP patients from the ongoing
GEMINI-1 Phase 3 trial in Q4 2023, whereafter we plan to out
license the program prior to a potential FDA approval.”
In the Phase 2 GALLOP study, a total of eight adult patients
with GPP flare were enrolled and received a 750mg IV dose of
imsidolimab and six patients were evaluable at both Day 29 and Day
113 and who also completed the study. Clinical responses were
observed as early as Day 3, most rapidly for pustulation relative
to other visible manifestations of GPP, with continued and
consistent improvement across multiple efficacy assessments at Day
8, Day 29, and through Day 113. Of the six patients evaluable on
Day 29, all achieved the primary endpoint of clinical response on
the clinical global impression scale (CGI). Additionally, the GPP
Physician Global Assessment (GPPPGA) scale was implemented by
protocol amendment during the trial and was assessed in four of the
eight enrolled patients, where zero (clear) or one (almost clear)
response was achieved in 50% (two) patients at Week 4. Six of eight
patients received a monthly 100mg subcutaneous dose of imsidolimab
beginning at Week 4 and continued through Week 12. At Week 16, 75%
(three of four) of evaluable patients were responders (clear or
almost clear) on the GPPPGA scale.
Imsidolimab was generally well-tolerated. Most
treatment-emergent adverse events (TEAEs) were mild to moderate in
severity. No patients discontinued the study due to a non-serious
TEAE. Two patients experienced serious adverse events (SAEs) that
recovered without sequelae. Through Week 16, anti-drug antibodies
were detected in one patient, which occurred at Week 12 and did not
impact imsidolimab pharmacokinetics, safety or efficacy.
Initial top-line Phase 2 study results were presented at
European Academy of Dermatology and Venerology (EADV) Congress in
October 2021.
GEMINI Phase 3 Studies
AnaptysBio is conducting two GPP Phase 3 trials for imsidolimab.
The first, called GEMINI-1, will enroll approximately 45
moderate-to-severe GPP patients, each experiencing an active flare
at baseline, who will be randomized equally to receive either a
single dose of 750mg IV imsidolimab, 300mg IV imsidolimab or
placebo. The primary endpoint of the Phase 3 program is the
proportion of patients achieving clear or almost clear skin as
determined by a GPPPGA score of zero or one at Week 4. Top-line
data from an interim analysis of GEMINI-1 is anticipated in the
fourth quarter of 2023.
Patients completing the GEMINI-1 trial can subsequently roll
over into GEMINI-2, the second Phase 3 trial for imsidolimab in
GPP, and will receive monthly doses of 200mg subcutaneous
imsidolimab or placebo. The objective of GEMINI-2 is to assess the
efficacy, durability of effect, recurrence of flare, and safety of
imsidolimab during up to three years of monthly dosing.
The U.S. Food and Drug Administration granted Orphan Drug
Designation to imsidolimab for the treatment of GPP in July
2020.
AnaptysBio announced in August 2022 that it intends to complete
execution of the GEMINI Phase 3 GPP program and out license
imsidolimab prior to potential FDA approval.
About AnaptysBio
AnaptysBio 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 planned Phase 2b trial
for the treatment of moderate-to-severe rheumatoid arthritis; and
ANB032, its BTLA agonist, in a planned 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, AnaptysBio 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.
AnaptysBio 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 imsidolimab’s
Phase 3 clinical trial in GPP; 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,”
“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 AnaptysBio, Inc.
858.732.0178investors@anaptysbio.com
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