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
positive topline data from an interim analysis of its Phase 2
clinical trial of imsidolimab for the treatment of
moderate-to-severe generalized pustular psoriasis (GPP), also known
as the GALLOP trial. GPP is a chronic, life-threatening, rare
inflammatory disease with no approved therapies.
“We are encouraged by the rapid onset, overall safety and
promising efficacy profile demonstrated to date by imsidolimab for
the treatment of patients suffering with GPP,” said Paul F. Lizzul,
chief medical officer of AnaptysBio. “We look forward to
engaging with regulatory authorities to progress imsidolimab into
Phase 3, and in doing so offer a potential therapeutic intervention
for these patients with high unmet medical need.”
“GPP is a life-threatening disease that seriously debilitates
patient lives with no approved therapies,” said Johann Gudjonsson,
Associate Professor of Dermatology, University of Michigan. “The
efficacy and safety demonstrated in this trial further validates
the potential for IL-36 receptor inhibition in helping GPP
patients. I look forward to advancement of imsidolimab for the
treatment of GPP and for other inflammatory conditions where this
target and pathway may play an important role.”
Study DataKey data available to date from the 8
patients enrolled in the GALLOP trial are as follows:
- Mean baseline value on the modified Japanese Dermatology
Association severity index total score (mJDA-SI) was 9 (Table 1),
body surface area covered by erythema and pustules was 24% and the
serum C-reactive protein (CRP) was 56 mg/L. Patients were on
average 51 years of age, 50% female and diagnosed with GPP for 4.3
years.
- Six of 8 (75%) patients treated with imsidolimab monotherapy
achieved the primary endpoint of improvement in the CGI scale on
Day 29. 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.
- mJDA-SI score, which incorporates both dermatological and
systemic aspects of GPP, decreased on average by 29% on Day 8 and
54% on Day 29. Erythema with skin pustules, which clinically
defines GPP, decreased by 60% on Day 8 and 94% on Day 29. Serum
CRP, which is an indicator of systemic inflammation, was normal
(less than 5 mg/L) for 5 of the 6 patients achieving the primary
endpoint on Day 29.
- Genotypic testing indicated homozygous wild-type IL-36RN,
CARD14 and AP1S3 alleles for all 8 patients. We believe this
suggests that imsidolimab is broadly applicable to pustular
diseases irrespective of genetic drivers.
- Anti-drug antibodies were not detected as of Day 29 in any
patient.
Endpoint |
Baseline |
Day 8 Relative to Baseline |
Day 29 Relative to Baseline |
Improvement on CGI |
N/A |
7 of 8 patients |
6 of 8 patients |
mJDA-SI |
9 |
-29% |
-54% |
Erythema with Skin Pustules(% body surface area) |
24% |
-60% |
-94% |
Table 1. Key endpoints at Day 8 and Day 29
relative to baseline.
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. One patient dropped out of the trial due
to a 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.
An end-of-Phase 2 meeting, based upon data available from the 8
patients enrolled in the GALLOP trial, is anticipated in Q4 2020.
In July 2020, the FDA granted orphan drug designation to
imsidolimab for the treatment of GPP based upon GALLOP clinical
data.
The Company plans to report full data from the GALLOP trial at a
medical conference in 2021.
GALLOP Phase 2 Trial DesignUpon review of Day
29 data from the 8 patients enrolled in the GALLOP trial, the
Company decided to curtail further enrollment and proceed with
preparations for an end-of-Phase 2 meeting with the FDA. Of these 8
patients, which include 3 patients reported in September 2019, 2
patients have completed the 16-week dosing period, 4 patients are
anticipated to complete the 16 week dosing period in Q4 2020 and 2
patients have dropped out to date.
Patients were screened among 12 sites located in the United
States and Europe. Patients were washed out of prior therapy and no
concomitant therapy was permitted during the trial. Rescue therapy
was not required by any patients while enrolled in 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 on Day 29 and Day
113 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.
In addition to GPP, the Company plans to advance development of
imsidolimab in multiple inflammatory indications associated with
IL-36 pathway dysregulation. Enrollment has been completed in
POPLAR, a randomized, placebo-controlled 50-patient Phase 2 trial
of imsidolimab in PPP, and top-line data is anticipated in Q1 2021.
The Company also plans, in Q1 2021, to initiate a worldwide patient
registry, called RADIANCE, of patients diagnosed with GPP and PPP,
which is anticipated to improve understanding of the patient
journey and support future clinical trial enrollment. In addition,
clinical development of imsidolimab is being expanded into two
additional indications, EGFR-mediated skin toxicity and ichthyosis,
where Phase 2 trials are expected to be initiated in Q4 2020.
About GPPGPP is a rare,
chronic life-threatening, inflammatory disease with no currently
approved therapies. 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. Primary market research, including
ICD-10 code claims, indicate that at least 3,000 moderate-to-severe
GPP patients in the United States are regularly treated by
dermatologists. GPP is known to be associated with excess signaling
through the IL-36 receptor, which can be caused by genetic
mutations and environmental factors.
About ImsidolimabImsidolimab,
previously known as ANB019, is an antibody that inhibits the
function of the interleukin-36-receptor, or IL-36R, which
AnaptysBio plans to initially develop as a potential first-in-class
therapy for patients suffering from generalized pustular psoriasis,
or GPP, palmoplantar pustulosis, or PPP, EGFR-mediated skin
toxicity and ichthyosis. AnaptysBio has previously presented data
from a Phase 1 clinical trial, which demonstrated safety,
pharmacokinetics and pharmacodynamic properties that supported
advancement of imsidolimab into Phase 2 studies.
About AnaptysBioAnaptysBio is 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. The Company’s proprietary anti-inflammatory pipeline
includes its anti-IL-36R antibody imsidolimab, previously referred
to as ANB019, for the treatment of rare inflammatory diseases,
including generalized pustular psoriasis, or GPP, palmoplantar
pustulosis, or PPP, EGFRi-mediated skin toxicities and ichthyosis;
its anti-IL-33 antibody etokimab, previously referred to as ANB020,
for the treatment of chronic rhinosinusitis with nasal polyps, or
CRSwNP, and eosinophilic asthma; its anti-PD-1 agonist program,
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
GlaxoSmithKline, including an anti-PD-1 antagonist antibody
(dostarlimab, GSK4057190A), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889A) 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 imsidolimab’s Phase 2 clinical trial in PPP, the
timing of an FDA end-of-Phase 2 meeting for imsidolimab in GPP, the
timing of initiation of the worldwide registry in GPP and PPP, the
timing of initiation of clinical trials in EGFR-mediated skin
toxicity and ichthyosis with imsidolimab and the timing of the full
data report of the GALLOP trial at a medical conference. 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.
Contacts:Dennis
MulroyAnaptysBio, Inc.858.732.0201dmulroy@anaptysbio.com
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