Preclinical data for SPY001 demonstrate the
potential for improved dosing over standard of care, including the
potential for dosing every eight or twelve weeks compared to dosing
every two weeks for subcutaneous vedolizumab
Interim subcutaneous pharmacokinetic and
safety data from healthy volunteers anticipated by year-end
2024
SPY002, an extended half-life anti-TL1A
antibody designed for enhanced potency to both TL1A monomers and
trimers, remains on track to begin first-in-human studies in the
second half of 2024
All three next-generation antibodies targeting
α4β7, TL1A, and IL-23 are on track to be in the clinic within 12
months, each serving as backbones for potential best-in-class
combinations
WALTHAM,
Mass., June 18, 2024 /PRNewswire/ -- Spyre
Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a
clinical-stage biotechnology company utilizing best-in-class
antibody engineering, rational therapeutic combinations, and
precision medicine approaches to target improved efficacy and
convenience in the treatment of Inflammatory Bowel Disease ("IBD"),
today announced that it has initiated dosing of healthy volunteers
in its first clinical trial of SPY001, an investigational novel
half-life extended anti-α4β7 monoclonal antibody.
"The Spyre team has executed efficiently to achieve this
milestone within a year of our public launch. SPY001 is the first
of our programs across three of the most impactful mechanisms in
IBD, namely α4β7, TL1A, and IL-23, all of which are expected to
enter the clinic within the next twelve months," said Cameron Turtle, D.Phil., Chief Executive Officer
of Spyre. "We look forward to highlighting interim data for SPY001
by the end of this year, which we expect will confirm that SPY001
is well tolerated with a half-life that enables a convenient Q8-12W
subcutaneous dosing schedule, with interim data for our T1LA
program to follow."
The SPY001 Phase 1 trial is a double blind, placebo-controlled
study in healthy volunteers and consists of a single-ascending dose
(SAD) component and a multi-ascending dose (MAD) component. The
study is expected to enroll approximately 48 healthy adult
participants into four SAD cohorts and two MAD cohorts. The primary
endpoint is safety, with pharmacokinetics (PK) serving as a
secondary endpoint. We expect interim safety and PK data from this
trial by year-end 2024. Pending data from the Phase 1 trial, the
company anticipates progressing into Phase 2 development with
SPY001 in 2025.
"α4β7 inhibition is a preferred first-line treatment option
among gastroenterologists given its favorable safety profile with a
gut-selective mechanism of action and demonstrated efficacy
superiority over TNF inhibition in the VARSITY study," said
Deanna Nguyen, M.D., SVP of Clinical
Development at Spyre. "We believe this unique safety and efficacy
profile, combined with a more convenient dosing frequency, could
make SPY001 an ideal backbone for combination therapy for IBD with
the inhibition of other highly active mechanisms including T1LA and
IL-23."
About SPY001
SPY001 is an investigational novel, subcutaneous extended
half-life monoclonal antibody targeting α4β7 for the potential
treatment of IBD. IBD is a chronic condition characterized by
inflammation in the gastrointestinal tract and encompasses two main
disorders: ulcerative colitis and Crohn's disease. In the United States, it is estimated that
approximately 2.4 million individuals currently have IBD. In
head-to-head preclinical studies, SPY001 demonstrated equivalent
potency to vedolizumab in blocking MadCAM-1 adhesion and exhibited
significantly longer half-life with the potential to deliver dosing
as infrequently as once every two or three months. A Phase 1 trial
of SPY001 in healthy volunteers is ongoing, and the Company expects
interim safety and pharmacokinetic data by year-end 2024. Pending
data from the Phase 1 trial, the company anticipates progressing
into Phase 2 development with SPY001 in 2025.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to
create next-generation inflammatory bowel disease (IBD) products by
combining best-in-class antibody engineering, rational therapeutic
combinations, and precision medicine approaches. Spyre's pipeline
includes extended half-life antibodies targeting α4β7, TL1A, and
IL-23. For more information, visit Spyre's website at
www.spyre.com.
Forward Looking Statements
Certain statements in this press release, other than purely
historical information, may constitute "forward-looking statements"
within the meaning of the federal securities laws, including for
purposes of the safe harbor provisions under the United States
Private Securities Litigation Reform Act of 1995, concerning Spyre
and other matters. These forward-looking statements include, but
are not limited to, express or implied statements relating to
Spyre's management team's expectations, hopes, beliefs, intentions
or strategies regarding the future of its pipeline and business
including, without limitation, Spyre's ability to achieve the
expected benefits or opportunities with respect to SPY001 including
obtaining interim data supporting target safety profile and dosing
schedule by end of year, the timing of commencing clinical studies
for Spyre's two other programs and obtaining interim data for
SPY002, patient enrollment results for the SPY001 Phase 1 trial and
the potential of SPY001, SPY002 and SPY003 to become backbones for
potential best-in-class combinations for IBD. In addition, any
statements that refer to projections, forecasts or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements. The words
"opportunity," "potential," "milestones," "pipeline," "can,"
"goal," "aim," "strategy," "target," "seek," "anticipate,"
"achieve," "believe," "contemplate," "continue," "could,"
"estimate," "expect," "intends," "may," "might," "plan,"
"possible," "predict," "project," "should," "will," "would" and
similar expressions (including the negatives of these terms or
variations of them) may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements are based on
current expectations and beliefs concerning future developments and
their potential effects. There can be no assurance that future
developments affecting Spyre will be those that have been
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond Spyre's control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited those uncertainties and factors described under
the heading "Risk Factors" and "Note about
Forward-Looking Statements" in Spyre's most recent Annual Report
on Form 10-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors
included in other filings by Spyre from time to time. Should one or
more of these risks or uncertainties materialize, or should any of
Spyre's assumptions prove incorrect, actual results may vary in
material respects from those projected in these forward-looking
statements. Nothing in this press release should be regarded as a
representation by any person that the forward-looking statements
set forth therein will be achieved or that any of the contemplated
results of such forward-looking statements will be achieved. You
should not place undue reliance on forward-looking statements in
this press release, which speak only as of the date they are made
and are qualified in their entirety by reference to the cautionary
statements herein. Spyre does not undertake or accept any duty to
make any updates or revisions to any forward-looking statements.
This press release does not purport to summarize all of the
conditions, risks and other attributes of an investment in
Spyre.
Follow Spyre Therapeutics on social media: @spyretx and
LinkedIn
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