Phase 1 interim results expected for SPY002,
two distinct extended half-life TL1A antibodies, in 2Q2025
Phase 1 interim results expected for SPY003,
an extended half-life IL-23 antibody, in 2H2025
Phase 2 platform trial in ulcerative colitis
(UC) remains on track for initiation in mid-2025 with SPY001
(α4β7), followed by SPY002 (TL1A), SPY003 (IL-23), and combinations
thereof, with initial results expected in 2026
Announces indication expansion into rheumatoid
arthritis (RA) with SPY002;
Phase 2 RA trial initiation
anticipated in mid-2025 with topline results in 2026
Strong balance sheet with preliminary cash,
cash equivalents, and marketable securities balance of over
$600M as of December 31, 2024*, anticipated to provide cash
runway into the second half of 2028
WALTHAM,
Mass., Jan. 13, 2025 /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 IBD and other immune-mediated
diseases, today highlighted its 2025 priorities, including:
upcoming first-in-human clinical data for SPY002 and SPY003, an
indication expansion of its SPY002 program into RA, and a plan to
deliver four clinical proof-of-concept readouts in 2026.
"Spyre made substantial progress in 2024 including entering
first-in-human studies with SPY001 and SPY002. We reported
outstanding interim Phase 1 results for SPY001 suggesting the
potential for quarterly or twice-annual dosing with a molecule that
has the potential to match or exceed the efficacy of the current
best-selling product in IBD and look forward to reporting interim
Phase 1 results for SPY002 and SPY003 in 2025. This year, we expect
to advance all three programs into a groundbreaking Phase 2
platform study in ulcerative colitis patients testing monotherapies
and combination therapies under a single master protocol," said
Cameron Turtle, DPhil, CEO of Spyre.
"We are also announcing the planned expansion of our SPY002 program
into RA, a debilitating condition affecting millions of patients
worldwide with continued unmet need for effective agents and
improved convenience. The potential benefit of anti-TL1A in RA is
supported by multiple lines of evidence including human genetics,
blood and tissue samples from RA patients, and animal models of
disease. With SPY002's class-leading potency and half-life
established in pre-clinical studies, it has the potential to become
the first-in-class and best-in-class anti-TL1A treatment for RA.
Between these planned Phase 2 studies in UC and RA, we expect to
deliver four proof-of-concept readouts in 2026."
Anticipated 2025 milestones for Spyre's next-generation
monotherapies
- SPY001 – a highly potent and selective, half-life extended,
investigational anti-α4β7 monoclonal antibody
-
- Initiation of Phase 2 proof-of-concept study in UC patients in
mid-2025 with target exposures that have the potential to increase
or accelerate efficacy
- Longer-term Phase 1 data expected to be presented at a medical
meeting in 2025, following interim data presented in November 2024 demonstrating SPY001 was well
tolerated with a half-life of >90 days, supporting Q3M-Q6M
dosing
- SPY002 – a program with two highly potent and selective,
half-life extended, investigational anti-TL1A monoclonal antibodies
- Phase 1 studies initiated in 4Q2024 for both anti-TL1A
molecules
- Phase 1 interim data for both molecules on track for
2Q2025
- SPY003 – a highly potent and selective, half-life extended
investigational monoclonal antibody targeting the p19 subunit of
IL-23
- Phase 1 initiation on track for 1Q2025
- Phase 1 interim data expected in 2H2025
Platform Phase 2 trial in ulcerative colitis evaluating
next-generation monotherapies and paradigm-changing
combinations
- Spyre plans to advance SPY001, SPY002, SPY003, and combinations
thereof into a double-blind, randomized, placebo-controlled, Phase
2 platform trial with a master protocol in patients with
moderately-to-severely active ulcerative colitis
- Platform trial is designed to efficiently evaluate each
of Spyre's monotherapy and combination therapies against a
common placebo control and to evaluate the contribution of each
monotherapy component to the safety and efficacy of Spyre's
combination therapies
- Trial is anticipated to initiate in mid-2025 with SPY001,
followed by SPY002, SPY003, and combinations thereof. All
investigational products in the study are expected to be dosed as
subcutaneous quarterly injections in the maintenance setting
with pharmacokinetic exposures targeting maximal efficacy
based on published exposure- or dose- responses for each mechanism
of action
- Initial open label monotherapy data from this study are
expected beginning in mid-2026, with full placebo-controlled data
expected in 2027
Rheumatoid arthritis indication expansion
- SPY002 (anti-TL1A) has first-in-class and best-in-class
potential in RA, a chronic autoimmune inflammatory condition that
affects millions of individuals worldwide
- Lack of response, insufficient response, or waning of response
to existing mechanisms highlights the need for new treatment
options
- TL1A levels are elevated in the blood and synovial fluid
of RA patients and higher TL1A levels are correlated with disease
severity
- TL1A blockade has been shown to be efficacious in murine
models of inflammatory arthritis. Blockade using Spyre's anti-TL1A
antibodies matched or exceeded the efficacy of anti-TNF treatment
in collagen-induced rat models of RA
- SPY002's projected quarterly to twice-annual subcutaneous
dosing in a single autoinjector has the potential to be the
most convenient product available for RA
- Phase 2 clinical trial initiation expected in mid-2025
with topline results in 2026
Strong financial position
The Company had a preliminary cash, cash equivalents, and
marketable securities balance of approximately $603 million as of December 31, 2024*. The Company anticipates that
this cash balance provides operational runway into the second half
of 2028.
* These preliminary selected financial results are
unaudited and subject to adjustment. The Company expects to report
its final and complete fourth quarter and full-year 2024 financial
results in late February
2025.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to
create next-generation inflammatory bowel disease (IBD) and other
immune-mediated disease 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
SPY001 and SPY002 molecules, including the potential for
quarterly or twice-annual dosing; the potential for its
product candidates to have efficacy improvement and convenience
advantage over existing products targeting IBD and RA; the
therapeutic benefits of its product candidates as monotherapies or
in combinations and their picomolar potencies, extended half-lives,
and high concentration formulations; the potential of a SPY002
molecule to be best-in-class half-life extended anti-TL1A
antibodies and best-in-class and first-in-class anti-TL1A treatment
for RA; the expected designs and timing of the platform Phase
2 trials in IBD and RA, including the selection of a SPY002
molecule for each planned Phase 2 trial and the timing of each
cohort; 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 for its studies in IBD; the
expected initiation of proof-of-concept studies, including number
of proof-of-concept studies and timing for receipt of readouts; its
plans to initiate a study of SPY002 in indications outside of IBD,
including timing thereof; potential market opportunities; the
Company's expected cash, cash equivalents and short-term
investments of approximately $603
million as of December 31,
2024; 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," "aim," "strategy," "target,"
"anticipate," "achieve," "believe," "contemplate," "continue,"
"could," "estimate," "expect," "intends," "may," "might," "plan,"
"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 trials, 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 platform 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.
