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
top-line proof-of-concept data from an interim analysis of an
ongoing Phase 2a trial in adult patients with peanut allergy.
Six of 13 (46%) patients exhibiting moderate-to-severe symptoms
during a baseline oral food challenge at enrollment improved peanut
tolerance to cumulative 500mg at day 14 after a single dose of
ANB020 compared to zero of three (0%) dosed with placebo.
Allergic symptoms that typically overlap with peanut allergy were
observed in four of five (80%) patients dosed with placebo but only
one of 15 (7%) ANB020-dosed patients. ANB020 was generally
well-tolerated and all patients remain enrolled in the clinical
trial. AnaptysBio plans to continue development of ANB020 in
moderate-to-severe baseline adult peanut allergy patients in a
Phase 2b multi-dose clinical trial.
“Peanut allergy is a serious medical condition often associated
with other food allergies, atopic dermatitis and asthma,” said
Stephen Tilles, M.D., Clinical Professor at the University of
Washington, Executive Director of Asthma Inc Clinical Research
Center, Immediate Past President of the American College of
Allergy, Asthma, and Immunology (ACAAI) and an investigator in this
Phase 2a clinical trial. “The data from this trial suggest
that ANB020 may be a promising new paradigm for peanut allergy
patients. Patients suffering from this debilitating condition
are motivated to pursue new treatments that provide protection from
the life-threatening symptoms of accidental peanut exposure.”
Phase 2a Trial DesignThis Phase 2a
proof-of-concept trial enrolled 20 adult peanut allergy patients
with a clinical history of anaphylaxis. The baseline peanut
tolerance of each patient was evaluated at enrollment using a
blinded, placebo-controlled oral food challenge (OFC) according to
PRACTALL guidelines, where each patient experienced dose limiting
symptoms at or before a cumulative 500mg dose of peanut
protein. Patients were subsequently randomized on a 3:1 basis
to receive a single intravenous 300mg dose of ANB020 or placebo at
14 days following the baseline OFC, and then administered a second
OFC at 14 days after dosing. Each OFC was limited to a
maximum of 500mg cumulative peanut dose. Symptom severity was
adjudicated by an independent, blinded assessor that was not
involved in performing the baseline or day 14 OFC.
Interim Analysis This interim analysis focused
on patients with moderate-to-severe baseline symptoms, which is the
patient population that AnaptysBio plans to target for future
development of ANB020 in adult peanut allergy. Thirteen
ANB020 dosed and three placebo dosed patients exhibiting
moderate-to-severe symptoms during the baseline OFC were included
in the analysis, while two ANB020 dosed and two placebo dosed
patients with mild baseline symptoms were excluded. The
average age and baseline peanut tolerability of moderate-to-severe
baseline patients was 31 and 239mg, respectively, which were
consistent with the age and baseline peanut tolerance of all 20
enrolled patients.
In patients with moderate-to-severe symptoms at baseline, six of
13 (46%) patients administered a single dose of ANB020 improved
peanut tolerance at the day 14 OFC to the maximum tested cumulative
500mg dose, compared to none of the placebo dosed patients.
Amongst the patients excluded due to mild baseline symptoms,
one ANB020 dosed patient and two placebo dosed patients improved
peanut tolerance to the 500mg cumulative dose at the day 14 OFC.
Concomitant allergy symptoms, typically overlapping with
peanut allergy, including urticaria, pruritus, rhinitis, asthma
flares and other nut allergies, occurred in four of five (80%)
patients following placebo administration but only occurred in one
of fifteen (7%) patients after ANB020 dosing.
ANB020 was generally well-tolerated during the study and all 20
patients remain enrolled with no dropouts. No serious adverse
events have been reported and the most frequent treatment-emergent
adverse event reported in ANB020 dosed patients was headache in
four of fifteen patients, of which three were mild cases and one
was moderate severity, while the most frequently reported adverse
events in placebo dosed patients were mild and moderate severity
allergy-related events in four of five patients.
“We are encouraged by the rapid improvement in peanut tolerance
and favorable safety profile observed to date in this study
following a single dose of ANB020,” said Hamza Suria,
president and chief executive officer of AnaptysBio. “We
believe ANB020 has the potential to prophylactically protect
moderate-to-severe baseline adult peanut allergy patients from
anaphylaxis. In addition, we believe ANB020 may address multiple
concomitant allergic conditions irrespective of the specific
allergens involved.”
The company plans to report detailed data from this trial at a
future medical conference following study completion.
AnaptysBio plans to continue development of ANB020 in a
randomized, double-blinded, placebo-controlled
subcutaneously-administered multi-dose Phase 2b trial in
moderate-to-severe baseline adult peanut allergy patients.
Conference Call & Webcast Information The
AnaptysBio management team will host a conference call and live
webcast with slides with the investment community today, Monday,
March 26th, 2018, at 5:00pm EDT to discuss the information in this
press release.When: March 26, 2018, 5:00pm EDT Dial-in: (833)
696-8361 (Domestic), (430) 775-1625 (International) Conference ID:
2289207
The live webcast and accompanying slides can be accessed under
the investor relations section of AnaptysBio’s website at
www.anaptysbio.com. A replay of the conference call will be
archived under the investor relations section of the AnaptysBio
website for 30 days shortly after the call.
About ANB020ANB020 is an antibody that
potently binds and inhibits the activity of interleukin-33, or
IL-33, a pro-inflammatory cytokine that multiple studies have
indicated is a central mediator of atopic diseases, including
atopic dermatitis, food allergies and asthma. Following completion
of a healthy volunteer Phase 1 trial of ANB020, AnaptysBio has
demonstrated proof-of-concept for ANB020 in a 12-patient Phase 2a
trial of moderate-to-severe adult atopic dermatitis and in the
aforementioned 20-patient placebo-controlled Phase 2a trial in
adult peanut allergy patients. Enrollment is ongoing in a
24-patient placebo-controlled Phase 2a trial of ANB020 in severe
adult eosinophilic asthma patients where top-line data are
anticipated in the third quarter of 2018. During the first half of
2018, AnaptysBio plans to initiate a placebo-controlled multi-dose
Phase 2b clinical trial of subcutaneously-administered ANB020 in
200-300 moderate-to-severe adult atopic dermatitis patients where
data is anticipated in 2019.
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 (ANB020) for the treatment of
moderate-to-severe adult atopic dermatitis, moderate-to-severe
adult peanut allergy and severe adult eosinophilic asthma; its
anti-IL-36R antibody (ANB019) for the treatment of rare
inflammatory diseases, including generalized pustular psoriasis and
palmo-plantar pustular psoriasis; and a portfolio of checkpoint
receptor agonist antibodies for the treatment of certain autoimmune
diseases where immune checkpoint receptors are insufficiently
activated, which have demonstrated efficacy in an animal model of
graft-versus-host disease. AnaptysBio’s antibody pipeline has been
developed using its proprietary somatic hypermutation (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 and an
inflammation partnership with Celgene, including an anti-PD-1
antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody
(TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which
are currently under clinical development with TESARO, and an
anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the
clinic with Celgene.
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 results of, and timing
of the release of data from, our clinical trials; the applicability
of interim results to the results of later trials, the potential of
ANB020 as a prophylactic therapeutic for the treatment of
moderate-to-severe adult peanut allergy patients; our ability to
launch future clinical trials and the success of our partnership
with TESARO and Celgene. 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
Chelcie ListerTHRUST Investor
Relations910.777.3049Chelcie@thrustir.com
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