Structure Therapeutics Initiates Phase 2a Study of Oral GLP-1 agonist GSBR-1290 for the Treatment of Type 2 Diabetes and Obesity
25 Mai 2023 - 10:30PM
Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global
biopharmaceutical company developing novel oral small molecule
therapeutics for metabolic and pulmonary diseases, today announced
that it has dosed the first patient in its Phase 2a study of its
highly selective oral GLP-1 agonist GSBR-1290 in adults who are
overweight or obese and otherwise healthy, and in adults with type
2 diabetes mellitus (T2DM) who are overweight or obese. The Company
has also initiated an ethnobridging study of GSBR-1290 in Japanese
individuals and is planning to initiate an additional formulation
bridging study to evaluate a tablet formulation of GSBR-1290 before
the end of the year, both in preparation for the planned global
Phase 2b study in 2024.
“The initiation of the Phase 2a clinical trial marks a major
milestone in our mission to bring an effective and convenient oral
therapy to patients living with type 2 diabetes and obesity,” said
Mark Bach, M.D., Ph.D., Chief Medical Officer of Structure
Therapeutics. “We are excited to advance GSBR-1290, an orally
available small molecule GLP1 agonist, into the next stage of
clinical development. This is the first program in our GLP-1
incretin franchise, and evaluating GSBR-1290 in Japanese patients
demonstrates our commitment to rapidly developing this treatment
globally.”
About the Phase GSBR-1290 development
programThe 12-week Phase 2a randomized, double-blind,
placebo-controlled, parallel group study evaluates the safety,
tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of
GSBR-1290. The study will enroll approximately 94 adult
participants, including 40 patients who are overweight or obese and
otherwise healthy, and 54 patients who are overweight or obese with
T2DM. Healthy obese/overweight patients will be randomized to
GSBR-1290 (n=24; 120 mg) or placebo (n=16), and T2DM patients will
be randomized to GSBR-1290 high-dose (n=26; 90 mg), GSBR-1290
low-dose (n=10; 45 mg), or placebo (n=18). All patients on
GSBR-1290 will receive multiple-ascending doses of GSBR-1290 once
daily (QD) titrated up over the first five to six weeks of the
study (depending on the cohort arm), with the target dose then
being maintained for the remainder of the 12-week period.
Topline data from the Phase 2a study as well as the Phase1b MAD
study are expected to be announced in the latter half of the fourth
quarter of 2023.
In addition, the Company has initiated a Phase 1 ethnobridging
study to evaluate the safety, tolerability, and PK of single and
multiple doses of GSBR-1290 in Japanese patients. The study will
include 12 healthy adult Japanese participants randomized 3:1 to
GSBR-1290 or placebo, and six non-Japanese participants who will
all receive GSBR-1290. All participants will receive GSBR-1290 once
daily (QD) for seven days at each dose, with a total of four doses
titrated up over a 4-week period). Successful completion of this
study is intended to enable inclusion of Japanese patients in the
planned global Phase 2b study in 2024.
The Company is also planning a separate formulation bridging
pharmacokinetic study to support the planned transition from
capsules to tablets. Pending supportive data from this bridging
study, the tablet formulation would be used in future GSBR-1290
studies starting with the planned Phase 2b study.
About GSBR-1290GSBR-1290 is an orally-available
small molecule agonist of the GLP-1 receptor, a validated drug
target for the treatment of) T2DM and obesity. The Company
completed its Phase 1 single ascending dose (SAD) study in
September 2022. GSBR-1290 was generally well tolerated and
demonstrated dose-dependent PK and PD activity in 48 healthy
volunteers. The Company has completed dosing of its Phase 1b
multiple ascending dose (MAD) study focused on safety, PK and
tolerability in 24 healthy volunteers.
About Structure TherapeuticsStructure
Therapeutics is a leading clinical-stage biopharmaceutical company
focused on discovering and developing innovative oral treatments
for chronic metabolic and pulmonary conditions with significant
unmet medical needs. Utilizing its next generation structure-based
drug discovery platform, the company has established a
scientifically-driven, GPCR-targeted pipeline, featuring two
wholly-owned proprietary clinical-stage small molecule compounds
designed to surpass the limitations of traditional biologic and
peptide therapies and be accessible to more patients around the
world. For additional information, please visit
www.structuretx.com.
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. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements, including, without limitation, statements concerning
the Company’s future plans and prospects, any expectations
regarding the safety or efficacy of GSBR-1290 and other candidates
under development, the ability of GSBR-1290 to treat type 2
diabetes, obesity or related indications, plans with respect to
regulatory submissions, the planned timing of the Company’s
clinical trials, data results and continued development of
GSBR-1290 and expectations regarding an oral development candidate
targeting GLP-1R. In addition, when or if used in this press
release, the words “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants, as they relate to the
Company may identify forward-looking statements. Forward-looking
statements are neither historical facts nor assurances of future
performance. Although the Company believes the expectations
reflected in such forward-looking statements are reasonable, the
Company can give no assurance that such expectations will prove to
be correct. Readers are cautioned that actual results, levels of
activity, safety, performance or events and circumstances could
differ materially from those expressed or implied in the Company’s
forward-looking statements due to a variety of risks and
uncertainties, which include, without limitation, risks and
uncertainties related to the Company’s ability to advance
GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic
candidates, obtain regulatory approval of and ultimately
commercialize the Company’s therapeutic candidates, the timing and
results of preclinical and clinical trials, the Company’s ability
to fund development activities and achieve development goals, the
impact of the ongoing COVID-19 pandemic, inflation, supply chain
issues, rising interest rates and future bank failures on the
Company’s business, its ability to protect its intellectual
property and other risks and uncertainties described in the
Company’s filings with the Securities and Exchange Commission
(“SEC”), including the Company’s quarterly Report on Form 10-Q
filed with the SEC on May 11, 2023 and its subsequent periodic
reports filed with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. The Company undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made,
except as required by law.
Contacts:
Investors:Jun Yoon, Chief Financial
OfficerStructure Therapeutics Inc.ir@structuretx.com
Media:Dan Budwick1ABDan@1abmedia.com
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