AnaptysBio Reports Imsidolimab POPLAR Phase 2 Clinical Trial in Moderate-to-Severe Palmoplantar Pustulosis (PPP) Did Not Meet...
March 08 2021 - 8:00AM
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
top-line data from its Phase 2 clinical trial of imsidolimab for
the treatment of moderate-to-severe palmoplantar pustulosis (PPP),
also known as the POPLAR trial, failed to meet its primary
endpoint.
While further clinical development in PPP is not currently
anticipated, AnaptysBio will continue development of imsidolimab in
five other immuno-dermatological indications, including GPP,
EGFRi-mediated skin toxicity, ichthyosis, hidradenitis suppurativa
and acne. Initiation of a Phase 3 clinical trial in GPP is
anticipated during mid-2021 following completion of protocol
alignment with the FDA.
“While the top-line results are disappointing, I would like to
sincerely thank everyone involved in the POPLAR trial, including
the patients, the investigators, their staff and our employees,”
said Hamza Suria, president and chief executive officer
of AnaptysBio. “Imsidolimab is currently being advanced in 5
other immuno-dermatology indications and we look forward to
multiple additional clinical readouts during 2021 and 2022.”
POPLAR Trial DataTop-line data from the POPLAR
trial are as follows:
- Mean baseline Palmoplantar Pustular Psoriasis Area Severity
Index (PPPASI) scores were 16 for the 30 patients enrolled in the
imsidolimab arm and 19 for the 29 patients enrolled in the placebo
arm, with an overall average of 18. Mean baseline Palmoplantar
Pustulosis Investigator Global Assessment (PPPIGA) was 3.1 for each
arm. Patients were on average 50 years of age and 78% were
female.
- The primary endpoint of least-squares mean difference (LSMD)
PPPASI improvement at week 16 (Day 113) was 6.1 for
imsidolimab-treated patients and 6.3 for placebo-treated patients
relative to their respective baselines, which has a p-value of 0.93
for the difference between the groups. Twenty-four patients
completed the week 16 primary endpoint analysis in each arm of the
trial.
LSMD PPPASI Relative to Baseline |
Imsidolimab |
Placebo |
Difference |
p-value |
Week 4 (Day 29) |
-3.1 |
-3.1 |
0.0 |
0.99 |
Week 8 (Day 59) |
-4.6 |
-3.7 |
-0.9 |
0.62 |
Week 12 (Day 85) |
-5.6 |
-3.4 |
-2.2 |
0.25 |
Week 16 (Day 113, primary endpoint) |
-6.1 |
-6.3 |
0.2 |
0.93 |
- Imsidolimab-treated patients had a mean PPPASI change from
baseline of 5.78 or 38% improvement, while placebo-treated patients
improved by 6.78 or 33% improvement, each relative to baseline.
Percent PPPASI improvement versus baseline was numerically greater
for imsidolimab-treated patients relative to placebo-treated
patients at each study timepoint (Days 3, 8, 15, 22, 29, 43, 57,
71, 85 and 113), ranging from approximately 3% to 19%.
- Nine (38%) patients achieved fifty percent PPPASI improvement
(PPPASI50) and 4 (17%) patients achieved seventy five percent
PPPASI improvement (PPPASI75) in the imsidolimab arm at week 16,
while 12 (50%) and 3 (13%) achieved these responder thresholds in
the placebo arm, respectively.
- Five (21%) imsidolimab-treated patients achieved a PPPIGA score
of zero (clear) or 1 (almost clear) at week 16 relative to 3 (13%)
placebo-dosed patients.
Percent Improvement Relative To Baseline at Week 16 |
Imsidolimab |
Placebo |
Mean PPPASI |
38 |
% |
33 |
% |
PPPASI50 |
38 |
% |
50 |
% |
PPPASI75 |
17 |
% |
13 |
% |
PPPIGA 0/1 |
21 |
% |
13 |
% |
- Imsidolimab was generally well-tolerated with a similar
frequency of adverse events between treatment groups, and no severe
or serious adverse events were observed in the imsidolimab arm. One
severe and one serious adverse event was reported in the
placebo-treated arm. The most common adverse events observed in the
imsidolimab and placebo arms were three and four cases of mild
nasopharyngitis, respectively, that were each deemed treatment
unrelated.
POPLAR Phase 2 Trial DesignFifty-nine PPP
patients were enrolled in this trial at 36 sites located within
North America and Europe. Patients were washed out of prior PPP
therapy and no concomitant therapy was permitted during the
trial. Key inclusion criteria included age between 18
and 75 years, clinically confirmed ongoing moderate-to-severe PPP
disease with minimum PPPIGA score of at least 3 (moderate), disease
history of at least 3 months, and active pustules on palms and/or
soles upon enrollment. Patients were treated with a 200mg
subcutaneous 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 mean change in PPPASI at week 16
relative to baseline and the estimator for between-group comparison
was LSMD. Baseline clinical assessments were conducted
for each patient on Day 1 prior to imsidolimab dosing. Missing data
was modeled using mixed model for repeated measures (MMRM)
methodology.
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, EGFR-mediated skin
toxicity, ichthyosis, hidradenitis suppurativa and acne.
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, EGFRi skin
toxicity, ichthyosis, hidradenitis suppurativa and acne; 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 our clinical trials, including imsidolimab’s Phase 2
clinical trials in EGFRi and ichthyosis; the timing of initiation
of imsidolimab’s Phase 2 clinical trials in hidradenitis
suppurativa and acne; and the timing of initiation of imsidolimab’s
Phase 3 clinical trial in GPP. 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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