AnaptysBio Presents Updated Data From Imsidolimab Phase 2 GALLOP Trial in Generalized Pustular Psoriasis
October 02 2021 - 12:00PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on emerging immune control mechanisms applicable to
inflammation and immuno-oncology indications, today announced that
week 16 data from the GPP GALLOP Phase 2 trial of imsidolimab, its
investigational anti-interleukin-36 receptor (IL-36R) therapeutic
antibody, was presented at the 2021 European Academy of Dermatology
and Venereology (EADV) Congress. The oral presentation, titled
“Imsidolimab, an Anti-IL-36 Receptor Monoclonal Antibody, in the
Treatment of Generalized Pustular Psoriasis: Results from a Phase 2
Trial”, was presented by Dr. Johann Gudjonsson, professor of
Dermatology at the University of Michigan.
“These promising results demonstrate the potential for
imsidolimab in the treatment of GPP patients,” said Dr. Johann
Gudjonsson. “GPP is a severely debilitating life-threatening
dermatological disease in need of novel therapeutic approaches. I
look forward to the advancement of imsidolimab in GPP Phase 3
trials.”
“I would like to thank all of the patients, physicians, nurses
and clinical research collaborators that helped AnaptysBio conduct
the GALLOP clinical trial,” said Dr. Paul Lizzul, chief medical
officer of AnaptysBio. “We are pleased to advance development of
imsidolimab across GPP, acne and hidradenitis suppurativa going
forward.”
Study DataKey data available to date from the 8
patients enrolled in the GALLOP trial are as follows:
- Six of 8 (75%) patients treated with imsidolimab monotherapy
achieved the primary endpoint of response on the clinical global
impression (CGI) scale at week 4 and week 16 (Table 1), without
requiring rescue medication. Two of 8 (25%) patients were
considered to have not met the primary endpoint because they
dropped out of the trial prior to Day 29.
- Modified Japanese Dermatology Association severity index total
score (mJDA-SI), which incorporates both dermatological and
systemic aspects of GPP, decreased on average by 29% at week 1, 54%
at week 4 and 58% at week 16. Erythema with pustules, which
clinically defines GPP, decreased by 60% at week 1, 94% by week 4
and 98% by week 16. Dermatology Life Quality Index (DLQI), which is
a patient-reported measure, achieved a reduction of 6 points at
week 4 and 11 points by week 16, each of which exceeded the minimal
clinically importance difference (MCID) of 4 points. GPP Physician
Global Assessment (GPPPGA) scale was implemented by protocol
amendment during the course of the trial and was assessed in 4 of
the 8 enrolled patients, where zero (clear) or 1 (almost clear)
response was achieved in 2 (50%) patients at week 4 and 3 (75%)
patients at week 16.
- Genotypic testing indicated homozygous wild-type IL-36RN,
CARD14 and AP1S3 alleles for all 7 tested patients.
- Through week 16, anti-drug antibodies were only detected in one
patient, which occurred at week 12 and did not impact imsidolimab
pharmacokinetics or efficacy.
Imsidolimab was generally well-tolerated and most
treatment-emergent adverse events were mild to moderate in severity
and resolved without sequelae.
No infusion or injection site reactions were observed. As
previously reported, one patient dropped out of the trial following
diagnosis of Staphylococcal aureus bacteremia in the first week,
which was a serious adverse event deemed to be possibly
drug-related. Because the patient was symptomatic prior to
dosing and had a prior medical history of bacteremia, a common
comorbidity of GPP, the Company does not believe this event is
likely attributable to imsidolimab. Another patient dropped out of
the study on Day 22 due to investigator reported inadequate
efficacy. One patient contracted COVID-19 during the course
of the trial, which was mild, unrelated to imsidolimab, and did not
lead to study discontinuation. |
Endpoint |
Baseline |
Week 1 Relative to Baseline |
Week 4 Relative to Baseline |
Week 16 Relative to Baseline |
CGI Responders |
N/A |
7 of 8 patients |
6 of 8 patients |
6 of 8 patients |
mJDA-SI |
9 |
-29% |
-54% |
-58% |
Erythema with Pustules(% body surface area) |
24% |
-60% |
-94% |
-98% |
DLQI |
16 |
-1 |
-6 |
-11 |
|
Table
1. Key endpoints at week 1, 4 and 16 relative to
baseline. |
GALLOP Phase 2 Trial DesignEight patients were
enrolled in the GALLOP trial from 12 sites in the United States and
Europe. Patients were washed out of prior therapy and no
concomitant therapy was permitted during the trial. Key inclusion
criteria include active ongoing GPP disease with a minimum mJDA-SI
score of 7 and at least 10% body surface area covered by active
pustules and erythema, while key exclusion criteria included
concomitant dermatological conditions or infection. Patients were
treated with a 750mg intravenous induction dose of imsidolimab at
day 1, followed by monthly 100mg subcutaneous doses on days 29, 57
and 85. The primary endpoint of this trial was clinical response on
the CGI scale at week 4 and week 16 without rescue therapy.
Baseline clinical assessments were conducted for each patient on
day 1 prior to imsidolimab dosing. Missing mJDA-SI data points were
imputed using last-observation-carry forward (LOCF)
methodology.
GEMINI Phase 3 Trial Following an end-of-Phase
2 meeting with the FDA in Q2 2021 where week 16 data from the
GALLOP Phase 2 trial was reviewed, AnaptysBio has initiated a
45-patient GPP Phase 3 trial of imsidolimab, called GEMINI-1, where
the primary endpoint is the proportion of patients achieving a
GPPPGA score of zero (clear) or 1 (almost clear) at week 4.
Patients completing GEMINI-1 will be enrolled in a subsequent
GEMINI-2 Phase 3 trial designed to assess 6 months of monthly
subcutaneous imsidolimab dosing. Over 50 global clinical sites will
be involved in screening GPP patients for enrollment. The Company
is also continuing enrollment of a global registry of GPP patients,
called RADIANCE, which is intended to improve understanding of the
GPP patient journey and support enrollment of GEMINI-1. The FDA has
previously granted orphan drug designation for imsidolimab for the
treatment of GPP.
Imsidolimab Clinical Development FocusGoing
forward, the Company has prioritized clinical development of
imsidolimab in GPP where Phase 3 GEMINI-1 has been initiated,
moderate-to-severe acne where Phase 2 ACORN top-line data is
anticipated in the first half of 2022 and moderate-to-severe
hidradenitis suppurativa where Phase 2 HARP top-line data is
anticipated in the second half of 2022. The company is
discontinuing imsidolimab clinical development for EGFR-mediated
skin toxicities and ichthyosis due to evolving clinical landscapes
for these indications and slower than anticipated enrollment.
About GPPGPP is a rare, chronic
life-threatening, inflammatory disease with no currently approved
therapies in the United States or Europe. Typically diagnosed after
age 30, these patients can die from complications of bacteremia,
sepsis, acute respiratory distress syndrome and cardiac failure.
Most patients are treated off-label with systemic anti-inflammatory
agents, including high-dose cyclosporine, methotrexate,
corticosteroids, retinoids or biologics, which are often tapered or
discontinued due to lack of efficacy or toxicity. GPP is known to
be associated with excess signaling through the IL-36 receptor,
which can be caused by genetic mutations and environmental factors.
Medical claims analyses recently conducted by IQVIA indicate
approximately 37,000 unique patients were diagnosed with GPP at
least once, and approximately 15,000 unique patients were diagnosed
with GPP at least twice, in the United States by a physician
between 2017 and 2019 using the International Classification of
Diseases 10th Revision (ICD-10) billing code pertaining to GPP
(L40.1).
About AnaptysBioAnaptysBio is a clinical-stage
biotechnology company developing first-in-class antibody product
candidates focused on unmet medical needs in inflammation. The
Company’s proprietary anti-inflammatory pipeline includes
imsidolimab, its anti-IL-36R antibody, previously referred to as
ANB019, for the treatment of dermatological inflammatory diseases,
including generalized pustular psoriasis, or GPP, acne and
hidradenitis suppurativa; rosnilimab, its anti-PD-1 agonist
program, previously referred to as ANB030, for treatment of certain
autoimmune diseases where immune checkpoint receptors are
insufficiently activated; and its BTLA modulator program, ANB032,
which is broadly applicable to human inflammatory diseases
associated with lymphoid and myeloid immune cell dysregulation.
AnaptysBio’s antibody pipeline has been developed using its
proprietary somatic hypermutation, or SHM platform, which uses in
vitro SHM for antibody discovery and is designed to replicate key
features of the human immune system to overcome the limitations of
competing antibody discovery technologies. AnaptysBio has also
developed multiple therapeutic antibodies in an immuno-oncology
collaboration with GSK, including an anti-PD-1 antagonist antibody
(JEMPERLI (dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist
antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist
antibody (GSK4074386), and an inflammation collaboration with
Bristol-Myers Squibb, including an anti-PD-1 checkpoint agonist
antibody (CC-90006) currently in clinical development.
Forward-Looking StatementsThis 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 our clinical trials, including imsidolimab’s Phase 2
clinical trials in acne and hidradenitis suppurativa. 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 our 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:Dennis MulroyAnaptysBio, Inc.
858-732-0201dmulroy@anaptysbio.com
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