AnaptysBio Reports Positive ANB019 Top-line Phase 1 Clinical Trial Results
November 06 2017 - 3:15PM
Robust Half-Life and Extended Pharmacodynamic
Activity Following a Single Dose of ANB019
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 top-line results from an interim analysis of an ongoing
single and multiple ascending dose Phase 1 trial of ANB019, its
investigational anti-interleukin-36 receptor (IL-36R) therapeutic
antibody, in healthy volunteers. Top-line data demonstrated
favorable safety, pharmacokinetics and pharmacodynamic properties
that support advancement of ANB019 into patient Phase 2
studies.
In the double-blind, placebo-controlled healthy
volunteer Phase 1 trial, 36 subjects were administered a single
subcutaneous or intravenous dose of ANB019 ranging between 10 mg
and 750 mg, 18 subjects were administered multiple ascending doses
of ANB019 intravenously ranging between 40 mg and 300 mg weekly for
four consecutive weeks and 18 subjects were dosed with placebo. All
subjects in the single and multiple ascending dose cohorts have
completed dosing. This interim analysis was conducted after the
85-day, post-dosing monitoring period has been completed for the
single ascending dose cohorts while monitoring is on-going for the
multiple ascending dose cohorts.
ANB019 was well-tolerated by all subjects and no
dose-limiting toxicities were observed to date. The most
frequent treatment-emergent adverse events observed in the single
ascending dose cohorts were mild upper respiratory tract infections
in 10 of 36 (28%) subjects dosed with ANB019 versus six of 12 (50%)
subjects dosed with placebo. No serious adverse events were
reported among the single ascending dose cohorts through completion
of monitoring, and none have been observed in the multiple
ascending dose cohorts to date.
The in vivo half-life of ANB019 was
approximately 28 days for both subcutaneous and intravenous routes
of administration, with bioavailability of approximately 90%. A
single dose of ANB019 at certain dose levels was able to completely
suppress IL-36 cytokine function for 85 days, as measured using an
ex vivo pharmacodynamic assay.
AnaptysBio plans to report detailed data from
this Phase 1 trial at a future medical conference. The company also
plans to initiate Phase 2 clinical trials of ANB019 in Generalized
Pustular Psoriasis (GPP) and Palmo-Plantar Pustular Psoriasis (PPP)
patients during 2018.
“We are thrilled to advance the development of
ANB019 for patients suffering from the debilitating effects of GPP
and PPP,” said Hamza Suria, president and chief executive officer
of AnaptysBio. “This program extends AnaptysBio’s vision of
building a first-in-class antibody pipeline for severe inflammatory
diseases.”
GPP is a life-threatening, rare, systemic
inflammatory disorder that, based on analysis of publicly available
data sources and interviews with physicians and key opinion leaders
in the field, AnaptysBio estimates affects approximately 3,000
patients in the United States with no approved therapies. Studies
have shown that GPP can be associated in some patients with
mutations that lead to abnormally high signaling through the
IL-36R, which the company believes may be addressed by treatment
with ANB019 irrespective of whether a GPP patient has a mutated
IL-36R signaling pathway. PPP is a non-fatal form of pustular
psoriasis that the company estimates affects approximately 150,000
patients in the United States alone. PPP is believed to be caused
by increased systemic levels of interleukin-36 resulting in
inflammatory pustules on the hands and feet of patients that cause
significant inability to stand, walk or do manual work, which the
company believes may be addressed by treatment with ANB019.
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, 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 Statements This
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
anticipated timing of the release of detailed results from ANB019’s
Phase 1 clinical trial, and the possibility and timing of
commencement of Phase 2 clinical trials of ANB019 for the treatment
of generalized pustular psoriasis and palmo-plantar pustular
psoriasis, and AnaptysBio’s ability to further advance the
development of ANB019 for the treatment of patients with
these diseases. Statements including words such as “plan,”
“continue,” “expect,” or “ongoing” and statements in the future
tense are forward-looking statements. Forward-looking statements
are subject to risks and uncertainties that may cause the company’s
actual activities or results to differ materially from those
expressed or implied 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: Chelcie Lister THRUST Investor
Relations 910.777.3049 chelcie@thrustir.com
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