Spyre is concurrently advancing two anti-TL1A
molecules into first-in-human studies
Preclinical data for both SPY002 molecules
demonstrate picomolar potency and potential for quarterly or
twice-yearly dosing, suggesting opportunity for improved efficacy
and convenience over first-generation anti-TL1As which are dosed
every two to four weeks
Interim pharmacokinetic, pharmacodynamic, and
safety data from healthy volunteers for both SPY002 molecules
anticipated in the second quarter of 2025
Spyre expects to introduce SPY002 to its
planned Phase 2 study in ulcerative colitis exploring quarterly
monotherapies and combinations; the Company also intends to
initiate a proof-of-concept Phase 2 study outside of IBD in
2025
Strong balance sheet with proforma cash, cash
equivalents, and marketable securities balance on September 30, 2024 of over $630M following recent oversubscribed
$230M financing, providing cash
runway into the second half of 2028
WALTHAM,
Mass., Dec. 2, 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 Phase 1 clinical trials of two investigational half-life
extended anti-TL1A monoclonal antibodies.
"TL1A inhibition has demonstrated compelling
efficacy in ulcerative colitis and Crohn's disease patients and has
been shown in pre-clinical IBD models to provide additive benefit
when used in combination with other targeted agents. Further, TL1A
is implicated in numerous inflammatory and fibrotic diseases beyond
IBD," said Josh Friedman, M.D.,
Ph.D., SVP of Clinical Development at Spyre. "Our SPY002 molecules
were engineered to build upon the evidence from first-generation
molecules with optimized properties including picomolar potencies,
extended half-lives, and high concentration formulations."
The SPY002 Phase 1 Trials (NCT06672718 and
NCT06622070) are double blind, placebo-controlled single-ascending
dose studies in healthy volunteers. The studies are each expected
to enroll approximately 56 healthy adult participants. The primary
endpoint is safety, with pharmacokinetics (PK) serving as a
secondary endpoint. Interim safety, PK, and pharmacodynamic (PD)
data from these trials are expected in the second quarter of 2025.
Pending data from the Phase 1 trials, the Company anticipates
progressing the SPY002 program into Phase 2 development in
2025.
"Entering the clinic with two optimized anti-TL1A
molecules is an exciting next step as we build upon our compelling
Phase 1 results for our next-generation anti-α4β7 antibody, SPY001,
which exhibited a greater than 90-day half-life enabling quarterly
or twice annual dosing in maintenance. Pending Phase 1 success and
regulatory feedback, we look forward to introducing one of the
SPY002 molecules into our groundbreaking Phase 2 platform study of
monotherapies and combination therapies in ulcerative colitis next
year, as well as initiating an efficient Phase 2 proof-of-concept
study outside of IBD," said Cameron
Turtle, D.Phil., Chief Executive Officer of Spyre. "Both of
these studies are fully financed following our recent
oversubscribed financing. The first-in-human study for SPY003, our
extended half-life IL-23 antibody, remains on track to initiate in
the first quarter of 2025, which will mark our fourth optimized
antibody to initiate clinical trials within nine months."
The Company had a pro forma cash balance of
approximately $630.1 million as of
September 30, 2024, which includes
cash, cash equivalents, and marketable securities as of
September 30, 2024 of approximately
$414.2 million, plus net proceeds of
approximately $215.9 million from the
Company's previously announced underwritten public offering,
including the full exercise by the underwriters of their option to
purchase additional shares of common stock, and assumes no other
changes to cash, cash equivalents and marketable securities since
September 30, 2024.
About SPY002-091 and SPY002-072
SPY002-091 and SPY002-072 are investigational,
extended half-life monoclonal antibodies targeting TL1A for the
potential treatment of inflammatory and fibrotic diseases including
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, SPY002 candidates demonstrated
equivalent or better potency to first-generation anti-TL1As and
exhibited significantly longer half-lives, with the potential for
quarterly or twice-yearly dosing. Spyre is advancing two molecules
into Phase 1 trials (NCT06672718 and NCT06622070), and the Company
expects interim safety, pharmacokinetic, and pharmacodynamic data
in the second quarter of 2025. Pending data from the Phase 1
trials, the Company anticipates progressing the SPY002 program into
Phase 2 development 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.
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, the
planned dosing regimen for SPY002 molecules, the potential for
efficacy improvement and substantial convenience advantage over
first-generation anti-TL1As, the therapeutic benefits of its
product candidates as monotherapies or in combinations and their
picomolar potencies, extended half-lives, and high concentration
formulations, the expected design and timing of the platform Phase
2 trial, including the selection of a SPY002 molecule for the
planned Phase 2 trial, its plans to conduct its first-in-human
study of SPY003, including expected timing thereof, the expected
timing for receipt of interim PK, PD and safety data, its plans to
initiate a study of SPY002 in indications outside of IBD, including
timing thereof, and the sufficiency of its cash runway into the
second half of 2028. 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 and clinical trial designs, including
the planned Phase 2 trial, to be materially different from those
expressed or implied by these forward-looking statements. These
risks and uncertainties include, but are not limited to regulatory
feedback including potential disagreement by regulatory authorities
with the Company's interpretation of data and the Company's planned
clinical trials for its product candidates, including the Company's
planned Phase 2 clinical trial design and 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.
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SOURCE Spyre Therapeutics, Inc.