AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on unmet medical needs in inflammation, today announced
positive topline data from an interim analysis of its Phase 2
clinical trial of ANB019 in moderate-to-severe generalized pustular
psoriasis (GPP) patients, also known as the GALLOP trial.
Enrollment is ongoing and AnaptysBio anticipates additional
clinical data and a regulatory strategy update for the development
of ANB019 in GPP during 2020. Moderate-to-severe GPP is a chronic,
life-threatening, rare inflammatory disease with no approved
therapies.
“Patients with GPP are urgently in need of safe and effective
therapeutic options,” said Hamza Suria, president and chief
executive officer of AnaptysBio. “We are pleased with the
benefit observed to date in this trial and look forward to data
from additional patients as the GALLOP trial continues. In addition
to GPP and palmo-plantar pustulosis, we believe excess IL-36
signaling may be involved in additional orphan dermatological
indications, which represent potential future development
opportunities for ANB019.”
Interim Analysis This interim analysis includes
two patients that have completed Day 113 and comprises all of the
data available from the ongoing Phase 2 study to date:
- Average baseline value for the modified Japanese Dermatology
Association score (mJDA, Table 1) was 9, for body surface area
covered by erythema and pustules was 27% and for serum C-reactive
protein (CRP) was 34 mg/L.
- Both patients achieved the primary endpoint of the study, which
is improvement in the clinical global impression scale (CGI, Table
2) at Day 29 and Day 113 with ANB019 monotherapy. Rescue therapy
was not required by either patient.
- Rapid and sustained disease score improvement was observed in
both patients (Table 3 and Figure 1). mJDA scores, which
incorporate dermatological and systemic aspects of GPP, decreased
by Day 8 and were maintained at 50% or greater reduction at almost
all timepoints during the study. Skin pustules, which are the key
dermatological sequelae of GPP, were completely cleared in both
patients by Day 8 and through Day 113. CRP, which measures systemic
inflammation, decreased to nearly normal levels in both
patients.
- Genotypic testing of these two patients indicated homozygous
wild-type IL-36RN, CARD14 and AP1S3 alleles, which suggests that
ANB019 may be broadly applicable to pustular disease patients
without a requirement for genetic screening.
- Anti-drug antibodies were not detected in either patient.
Parameter |
Timepoint |
Reduction Relative to Baseline |
Patient 1 |
Patient 2 |
Average |
mJDA Score |
Day 8 |
67% |
50% |
58% |
Day 15 |
50% |
58% |
54% |
Day 22 |
50% |
67% |
58% |
Day 29 |
33% |
67% |
50% |
Day 57 |
50% |
67% |
58% |
Day 85 |
67% |
75% |
71% |
Day 113 |
50% |
75% |
63% |
Body surface area covered by erythema with pustules |
Day 8 |
100% |
100% |
100% |
Day 15 |
100% |
100% |
100% |
Day 22 |
100% |
100% |
100% |
Day 29 |
100% |
100% |
100% |
Day 57 |
100% |
100% |
100% |
Day 85 |
100% |
100% |
100% |
Day 113 |
100% |
100% |
100% |
CRP |
Day 8 |
3% |
90% |
47% |
Day 15 |
11% |
95% |
53% |
Day 22 |
61% |
96% |
78% |
Day 29 |
64% |
96% |
80% |
Day 57 |
78% |
92% |
85% |
Day 85 |
59% |
94% |
77% |
Day 113 |
57% |
93% |
75% |
Table 3. Reduction in mJDA score, body surface area
covered by erythema with pustules and CRP following ANB019
administration for the two patients included in this interim
analysis.
ANB019 was generally well-tolerated and no serious or severe
adverse events were reported in this interim analysis. Separately,
one additional patient dropped out of the trial due to diagnosis
with Staphylococcal aureus bacteremia on Day 3 post-ANB019
administration, which was a serious adverse event deemed to be
possibly drug-related. Because this patient had a prior
medical history of bacteremia, which is a common morbidity of GPP,
the Company does not believe this event is likely due to ANB019
treatment. No data on this patient were collected post-ANB019
administration and therefore this patient was not included in the
interim
analysis. GALLOP
Phase 2 Trial DesignThis Phase 2 trial is enrolling up to
10 severe adult GPP patients at 7 sites in the United States and
the United Kingdom. Key inclusion criteria include active
ongoing GPP disease with a minimum mJDA score of 7 and at least 10%
body surface area covered by pustules, while key exclusion criteria
include concomitant dermatological conditions or infection.
Each patient included in this interim analysis completed a
washout period of at least 4 weeks prior to Day 1. Patients
are dosed with a 750mg intravenous loading dose of ANB019 at Day 1,
followed by monthly 100mg subcutaneous doses on Days 29, 57 and
85. Rescue therapy, including cyclosporine, methotrexate and
retinoids, is permitted if any enrolled patient does not show
improvement, in accordance with CGI relative to baseline, by Day
29. Patients are deemed to have achieved the primary endpoint
if they demonstrate improvement in the CGI scale on Day 29 and Day
113 without any use of rescue therapy. Baseline clinical
assessments are conducted for each patient on Day 1 prior to ANB019
dosing. Based on the results of this interim analysis,
AnaptysBio is curtailing the washout period required prior to
enrollment.
About GPPModerate-to-severe GPP is a chronic,
life-threatening, rare 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 with systemic anti-inflammatory agents,
including high-dose cyclosporine, methotrexate and retinoids, which
are often tapered or discontinued due to 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 ANB019ANB019 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, and palmoplantar pustulosis, or PPP. AnaptysBio has
previously presented data from a Phase 1 clinical trial, which
demonstrated favorable safety, pharmacokinetics and pharmacodynamic
properties that supported advancement of ANB019 into Phase 2
studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study
of ANB019 in GPP where additional clinical data and a regulatory
strategy update is anticipated in 2020. The Company is also
conducting its POPLAR trial, a Phase 2 study in PPP where top-line
data is anticipated in the first half of 2020.
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 its
anti-IL-33 antibody etokimab, previously referred to as ANB020, for
the treatment of moderate-to-severe atopic dermatitis, eosinophilic
asthma, and adult chronic rhinosinusitis with nasal polyps, or
CRSwNP; its anti-IL-36R antibody ANB019 for the treatment of rare
inflammatory diseases, including generalized pustular psoriasis, or
GPP, and palmoplantar pustulosis, or PPP; and its PD-1 agonist
program, ANB030, and other novel anti-inflammatory checkpoint
receptor modulator antibodies for treatment of certain autoimmune
diseases where immune checkpoint receptors are insufficiently
activated. 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
partnership with TESARO, a GSK company, including an anti-PD-1
antagonist antibody (dostarlimab (TSR-042)) which is anticipated to
achieve BLA filing in late 2019, an anti-TIM-3 antagonist antibody
(TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an
inflammation partnership with Celgene, 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 ANB019’s
Phase 2 clinical trials in GPP and PPP; timing of a regulatory
strategy update for GPP; and statements by AnaptysBio’s president
and chief executive officer. 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:Monique AllaireTHRUST Investor
Relations617.895.9511monique@thrustir.com
mJDA Index Components |
Score |
0 |
1 |
2 |
3 |
Dermatological components, % of body surface area covered by |
Erythema with pustules |
0% |
>0%, <10% |
≥10%, <50% |
≥50% |
Erythema |
0% |
>0%, <25% |
≥25%, <75% |
≥75% |
Edema |
0% |
>0%, <10% |
≥10%, <50% |
≥50% |
Systemic components |
Fever (degrees C) |
<37 |
≥37, <38.5 |
≥38.5 |
Not applicable |
White blood cell count (/microliter) |
<10,000 |
≥10,000, <15,000 |
≥15,000 |
Not applicable |
CRP (mg/L) |
<3 |
≥3, <70 |
≥70 |
Not applicable |
Serum albumin (g/L) |
≥3.8 |
<3.8, ≥3.0 |
<3.0 |
Not applicable |
Table 1. Patient mJDA scores are calculated by aggregating
the above component scores at each timepoint. Moderate-to-severe
patients range from a minimum of 7 to a maximum of 17 on the mJDA
index. Adapted from Imafuku et al, J. Dermatology, 2016;
43:1011-1017, Table S1.
CGI Improvement Levels |
Improvement Criteria |
mJDA score change relative to baseline |
and/or |
Other parameters |
Very much improved |
Reduction by ≥3 points |
or |
Clear or almost clear signs of GPP |
Much improved |
Reduction by 1 or 2 points |
or |
Reduction in pustules by 30%, or clinically meaningful improvement
of at least 2 other components of the mJDA |
Minimally improved |
No change |
and |
Reduction in pustules by 20%, or clinically meaningful improvement
of at least 1 other components of the mJDA |
No change |
No change |
and |
Did not meet the criteria of “minimally improved” |
Worsened |
≥1 point increase |
|
Not applicable |
Table 2. CGI objectively determines disease improvement
and need for rescue therapy. Rescue therapy was permitted
only if a patient did not show improvement (minimally, much or very
much improved) with ANB019 monotherapy by Day 29. Adapted
from Imafuku et al, J. Dermatology, 2016; 43:1011-1017, Table
S2.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/28d1a547-2ef2-4d08-9a57-10b57f8be86f
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