AnaptysBio Reports Etokimab ATLAS Phase 2b Clinical Trial in Moderate-to-Severe Atopic Dermatitis Fails to Meet Primary Endpo...
09 November 2019 - 12:00AM
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
topline data from its ATLAS trial, a Phase 2b randomized,
double-blinded, placebo-controlled, multi-dose study in
approximately 300 adult patients treated with etokimab in
moderate-to-severe atopic dermatitis. Each of the etokimab
dosing arms failed to meet the primary endpoint of the trial, which
was demonstration of statistically greater improvement in the
Eczema Area and Severity Index (EASI) relative placebo at week
16. The Company will be receiving additional data and plans
to provide a detailed update in the first quarter of 2020.
As a result of this topline data, the Company has
decided to postpone the initiation of its Phase 2b etokimab
clinical trial in eosinophilic asthma, a multi-dose, randomized,
double-blinded, placebo-controlled trial in 300-400 patients, until
it has the opportunity to analyze the full data set from the ATLAS
trial. The Company will continue conducting its ECLIPSE
trial, a randomized, placebo-controlled Phase 2 trial in
approximately 100 adult patients with chronic rhinosinusitis with
nasal polyps, with topline data from an interim analysis expected
in the first quarter of 2020.
“We are surprised and very disappointed by the
topline results of the ATLAS trial,” said Hamza Suria, president
and chief executive officer of AnaptysBio. “We would like to
thank all involved in the participation and support of the ATLAS
study, including the patients, the investigators, their staff and
our employees. We look forward to continuing our strategy of
advancing our wholly-owned clinical and preclinical pipeline
programs.”
About AnaptysBio
AnaptysBio 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)), 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
updated data from etokimab’s Phase 2b clinical trial in
moderate-to-severe adult atopic dermatitis patients and data from
etokimab’s Phase 2 clinical trial in adult patients with chronic
rhinosinusitis with nasal polyps. 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:Eric LoumeauAnaptysBio,
Inc.858.732.0179eloumeau@anaptysbio.com
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