AnaptysBio Reports HARP Phase 2 Top-Line Data of Imsidolimab in Moderate-to-Severe Hidradenitis Suppurativa
August 31 2022 - 4:15PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced top-line data from its HARP Phase 2 trial for the
treatment of moderate-to-severe hidradenitis suppurativa (HS). The
trial indicated imsidolimab was safe and well tolerated, however
did not demonstrate efficacy over placebo in the trial’s primary
endpoint and key secondary endpoints. Clinical development of
imsidolimab is being discontinued in hidradenitis suppurativa.
“HS is a severely debilitating, painful and chronic skin disease
with substantial unmet need. Although the results of this
hidradenitis suppurativa trial are disappointing, we are very
grateful to the patients, investigators and our employees involved
in conducting this trial,” said Dr. Paul F. Lizzul, chief medical
officer.
Imsidolimab previously demonstrated efficacy and safety in the
GALLOP Phase 2 trial in generalized pustular psoriasis (GPP), a
systemic, life-threatening inflammatory disease in which
imsidolimab has been granted Orphan Disease Designation. Enrollment
of the GEMINI-1 GPP Phase 3 registrational trial is ongoing and
top-line data is anticipated in Q4 2023. The company plans to
outlicense investigational imsidolimab prior to potential FDA
approval for the treatment of GPP.
AnaptysBio also continues to advance the development of two
wholly-owned immune cell modulators targeting PD-1 and BTLA for
autoimmune and inflammatory disease. Top-line data from the AZURE
Phase 2 trial of rosnilimab, a PD-1 agonist antibody, in
moderate-to-severe alopecia areata is anticipated in the first
quarter of 2023, and the company expects to file a U.S. IND for an
initial Phase 2 trial of ANB032, a BTLA agonist antibody, in the
fourth quarter of 2022.
“The IL-36 pathway plays a key role in the disease pathology of
GPP. While we remain optimistic that imsidolimab, an IL-36 receptor
antagonist, can meaningfully impact the treatment of patients with
GPP, as part of our ongoing strategic portfolio review we have made
the decision to complete execution of our Phase 3 program and
outlicense imsidolimab prior to potential FDA approval,” said
Daniel Faga, interim president and chief executive officer of
AnaptysBio. “We’re well capitalized with over $570 million in cash
at the end of Q2, and excited to focus on the R&D of our novel
immune cell modulator pipeline, including our two checkpoint
agonists in clinical-stage development, rosnilimab and ANB032. We
believe their mechanisms of action, acting directly on cell types
mediating disease pathology, have the potential to treat a broad
range of autoimmune and inflammatory disorders.”
HARP P2b Trial Top-line Results
Trial design:
- This double-blind, placebo-controlled Phase 2 trial enrolled
149 patients, at sites located within North America and Europe,
with moderate to severe hidradenitis suppurativa. Key inclusion
criteria included age between 18 and 75 years, clinically confirmed
ongoing moderate-to-severe HS with at least 5 inflammatory nodule
and abscess (AN) lesion count, less than 20 draining fistulas and
at least Hurley stage 2.
- Patients received subcutaneous monthly doses of imsidolimab 400
mg/200mg (n=50), imsidolimab 200 mg/100mg (n=50), or placebo (n=49)
in a 16-week treatment double-blind placebo-controlled period
followed by a 16-week extension period. Placebo patients were
re-randomized in a 1:1 ratio to imsidolimab 400 mg/200 mg or
imsidolimab 200 mg/100 mg in the extension period.
- Mean baseline total inflammatory nodule and abscess (AN) lesion
count for the imsidolimab high dose arm, the imsidolimab low dose
arm and placebo arm were 14.0, 11.9 and 12.1, respectively. Mean
baseline draining fistula count for high dose arm, low dose arm and
placebo arms were 4.1, 2.7 and 3.1, respectively.
Safety and tolerability data:
- Imsidolimab was safe and well tolerated with no
imsidolimab-related serious or severe adverse events reported.
- The majority of treatment-emergent adverse events (TEAEs),
except for COVID-19, were related to underlying HS, were mild to
moderate in both imsidolimab arms and resolved without leading to
treatment discontinuation and number of TEAEs or TEAE timing did
not correlate with dosing.
- The most common TEAEs observed across imsidolimab and placebo
dosed patients were COVID-19 (n=10) and Hidradenitis (n=8), which
were deemed unrelated to treatment.
- Serious TEAEs were observed in 6.1% (n=3) of placebo patients
vs. 4.0 % (n=2) on imsidolimab low dose and 0 in the imsidolimab
high dose. Two cases were COVID-19 that occurred in the imsidolimab
low dose arm, and all other Serious TEAEs occurred in placebo arm,
including right ring finger abscess, abortion spontaneous, and
worsening HS.
Patients with: |
ImsidolimabHigh Dose |
ImsidolimabLow Dose |
Placebo |
Overall |
At least 1 TEAE |
38.0% (19) |
28.0% (14) |
34.7% (17) |
33.6% (50) |
AE related to treatment |
12.0% (6) |
10.0% (5) |
6.1% (3) |
9.4% (14) |
AE related to COVID-19 |
8.0% (4) |
6.0% (3) |
6.1% (3) |
6.7% (10) |
AE related to Hidradenitis |
2.0% (1) |
6.0% (3) |
8.2% (4) |
5.4% (8) |
Serious AE (SAE) |
0 |
4.0% (2) |
6.1% (3) |
3.4% (5) |
SAE related to treatment |
0 |
0 |
0 |
0 |
Severe TEAE |
0 |
2.0% (1) |
8.2% (4) |
3.4% (5) |
Severe TEAE related to treatment |
0 |
0 |
0 |
0 |
Efficacy data:
- The primary endpoint was mean change in AN lesion count from
baseline at week 16.
- A secondary endpoint, the Hidradenitis Suppurativa Clinical
Response (HiSCR) measure, was also assessed to measure improvement
in HS. HiSCR50 is defined as at least 50 percent reduction from
baseline AN lesion count and no increase for either abscess or
draining fistula count at 16 weeks. HiSCR50 is the endpoint that
has been utilized to date for evaluation of HS by regulatory
agencies.
Endpoint at Week 16 |
Imsidolimab |
Placebo |
Difference of Imsidolimabvs Placebo |
High Dose |
Low Dose |
|
High Dose |
Low Dose |
Mean AN Count Change from Baseline (SD) |
-5.9(6.05) |
-4.1(4.63) |
-5.6(7.40) |
-0.3(p=0.7841) |
1.3(p=0.2885) |
Mean Percent AN Count Change from Baseline (SD) |
-44.7(39.23) |
-36.7(36.59) |
-41.2(43.69) |
-4.8(p=0.5939) |
3.5(p=0.7002) |
HiSCR50 (%) |
41.0 |
39.0 |
35.7 |
6.0(p=0.5848) |
3.4(p=0.7522) |
About AnaptysBioAnaptysBio is a
clinical-stage biotechnology company focused on delivering
innovative immunology therapeutics. We are developing immune cell
modulators, including two checkpoint agonists in clinical-stage
development, for autoimmune and inflammatory disease: rosnilimab,
our anti-PD-1 agonist program in Phase 2 for the treatment of
moderate-to-severe alopecia areata; and ANB032, our anti-BTLA
agonist program, which is broadly applicable to human inflammatory
diseases associated with lymphoid and myeloid immune cell
dysregulation. AnaptysBio is also developing imsidolimab, our
anti-IL-36R antibody in Phase 3 for the treatment of generalized
pustular psoriasis, or GPP. AnaptysBio’s antibody pipeline has been
developed using our 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).
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 3 trial in GPP and rosnilimab’s Phase 2 trial
in alopecia areata; timing of an IND filing for ANB032; and our
ability to complete, and timing with respect to, any outlicensing
transaction with imsidolimab. 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 presentation, 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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