-- Exceeded enrollment target due to patient
demand; trial size increased to 121 patients --
-- Bempikibart topline results remain on track
to be released in Q4'24 --
WALTHAM,
Mass., July 9, 2024 /PRNewswire/ -- Q32 Bio Inc.
(NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company
focused on developing biologic therapeutics to restore immune
homeostasis, today announced that it has completed enrollment in
the SIGNAL-AD Phase 2 clinical trial of bempikibart (ADX-914) for
the treatment of persistent, moderate-to-severe atopic dermatitis
(AD). Bempikibart is a fully human anti-IL-7Rα antibody that
is designed to re-regulate adaptive immune function by blocking
IL-7 and TSLP signaling, both of which contribute to inflammation
and injury in a diversity of autoimmune disorders.
"We are grateful to the patients and their clinical teams whose
high level of interest enabled us to complete enrollment on
schedule while exceeding our original target enrollment," said
Jason Campagna, M.D., Ph.D., Chief
Medical Officer of Q32 Bio. "We believe that this demand speaks to
both the enthusiasm following completion of Part A of the trial and
the unmet need for patients with AD."
"In addition to completing enrollment in SIGNAL-AD, we
previously announced that enrollment in the SIGNAL-AA Phase 2
clinical trial in severe alopecia areata (AA) is also complete,
marking the achievement of two critical milestones this year," said
Jodie Morrison, Chief Executive
Officer of Q32 Bio. "We are thrilled with our continued progress
advancing bempikibart and we look forward to sharing topline data
from both Phase 2 clinical trials in the fourth quarter of this
year."
SIGNAL-AD (NCT05509023) is a two-part Phase 2, randomized,
double-blind, placebo-controlled, multi-center clinical trial
evaluating bempikibart in adult patients with persistent,
moderate-to-severe AD. Part A was conducted to evaluate safety, PK,
and to enable dose selection for Part B of the clinical trial. Part
A was completed, but data remains blinded. Part B is being
conducted to evaluate the efficacy and safety of bempikibart as
compared with placebo. In Part B, patients were enrolled 1:1 in the
bempikibart 200 mg Q2W SC flat dose and placebo arms for 12 weeks
of treatment. The primary endpoint is the mean percent change from
baseline to week 14 in the Eczema Area and Severity Index (EASI)
score. Patients will be followed for an additional 12 weeks
following completion of treatment.
A total of 121 patients were enrolled, including 15 patients in
Part A. Total enrollment exceeded the initial target of
approximately 100 patients due to Part B patient enrollment demand.
Topline data from Parts A and B are expected in the fourth quarter
of 2024.
AD is the most common type of eczema and affects more than 25
million people in the United
States. In individuals with AD, the immune system is
overactive, triggering inflammation that damages the skin
barrier.
About Bempikibart
Bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody that is
designed to re-regulate adaptive immune function by blocking IL-7
and TSLP signaling. Q32 Bio is currently evaluating bempikibart in
two ongoing Phase 2 clinical trials: SIGNAL-AD, a Phase 2 study in
patients with atopic dermatitis (AD) and SIGNAL-AA, a Phase 2 study
in patients with alopecia areata (AA).
About Q32 Bio
Q32 Bio is a clinical stage biotechnology company developing
biologic therapeutics targeting potent regulators of the innate and
adaptive immune systems to re-balance immunity in autoimmune and
inflammatory diseases. Q32 Bio's lead programs, focused on the IL-7
/ TSLP receptor pathways and complement system, address immune
dysregulation to help patients take back control of their
lives.
Q32 Bio's program for adaptive immunity, bempikibart (ADX-914),
is a fully human anti-IL-7Rα antibody that re-regulates adaptive
immune function for the treatment of autoimmune diseases. It is
being evaluated in two Phase 2 trials for the treatment of atopic
dermatitis and alopecia areata. The IL-7 and TSLP pathways have
been genetically and biologically implicated in driving several T
cell-mediated pathological processes in numerous autoimmune
diseases. Q32 Bio's program for innate immunity, ADX-097, is based
on a novel platform enabling tissue-targeted regulation of the
complement system without long-term systemic blockade – a key
differentiator versus current complement therapeutics. Q32 Bio has
completed a first-in-human, Phase 1 ascending dose clinical study
of ADX-097 in healthy volunteers.
For more information, visit www.Q32Bio.com.
Availability of Other Information About Q32 Bio
Investors and others should note that we communicate with our
investors and the public using our company
website www.Q32Bio.com, including, but not limited to, company
disclosures, investor presentations and FAQs, Securities and
Exchange Commission filings, press releases, public conference
call transcripts and webcast transcripts, as well as on X (formerly
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or on X or LinkedIn could be deemed to be material information. As
a result, we encourage investors, the media and others interested
to review the information that we post there on a regular basis.
The contents of our website or social media shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995, as amended, relating to our business, operations and
financial condition, and our expectations regarding the timing and
data from our Phase 2 clinical trials for bempikibart in AA and AD
in the fourth quarter of 2024.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as "may," "will," "should,"
"would," "expect," "anticipate," "plan," "likely," "believe,"
"estimate," "project," "intend," and other similar expressions
among others. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on
current beliefs and assumptions that are subject to risks and
uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including, without limitation: the ability to integrate our
business with our merger partner successfully and to achieve
anticipated synergies; the possibility that other anticipated
benefits of the merger will not be realized, including without
limitation, anticipated revenues, expenses, earnings and other
financial results, and growth and expansion of our operations, and
the anticipated tax treatment of the merger; our ability to retain,
attract and hire key personnel; potential adverse reactions or
changes to relationships with employees, suppliers or other parties
resulting from the completion of the merger; potential
business uncertainty, including changes to existing business
relationships that could affect our financial performance; the need
for additional funding, which may not be available; failure to
identify additional product candidates and develop or commercialize
marketable products; the early stage of our development efforts;
potential unforeseen events during clinical trials could cause
delays or other adverse consequences; risks relating to the
regulatory approval process; interim, topline and preliminary data
may change as more patient data become available, and are subject
to audit and verification procedures that could result in material
changes in the final data; our product candidates may cause serious
adverse side effects; the inability to maintain our collaborations,
or the failure of these collaborations; our reliance on third
parties, including for the manufacture of materials for our
research programs, preclinical and clinical studies; failure to
obtain U.S. or international marketing approval; ongoing
regulatory obligations; effects of significant competition;
unfavorable pricing regulations, third-party reimbursement
practices or healthcare reform initiatives; product liability
lawsuits; securities class action litigation; the impact of
global pandemics and general economic conditions on our business
and operations, including the our preclinical studies and clinical
trials; the possibility of system failures or security breaches;
risks relating to intellectual property; significant costs incurred
as a result of operating as a public company; and such other
factors as are set forth in Q32 Bio's periodic public filings with
the SEC, including but not limited to those described under the
heading "Risk Factors" in our Form 10-Q for the quarter ended
March 31, 2024 filed on May 9, 2024. Except as required by applicable
law, we undertake no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts:
Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
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