Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global
biopharmaceutical company developing novel oral small molecule
therapeutics for metabolic and cardiopulmonary diseases, today
announced positive results from the Phase 1b multiple ascending
dose (MAD) study of its highly selective oral GLP-1 receptor
agonist, GSBR-1290, in healthy overweight or obese individuals. In
the 28-day study, GSBR-1290 demonstrated significant weight loss
supporting once-daily (QD) dosing and an encouraging safety and
tolerability profile.
“These positive Phase 1b results support GSBR-1290 as a
promising, differentiated oral GLP-1 receptor agonist with
once-daily dosing,” said Raymond Stevens, Ph.D., Founder and CEO of
Structure. “GSBR-1290 demonstrated an encouraging safety and
tolerability profile with no adverse event-related discontinuations
and we are encouraged by the weight loss observed following four
weeks of treatment. We look forward to sharing results of GSBR-1290
over a longer 12-week period in the Phase 2a study, and we continue
to move forward with all activities in order to begin Phase 2b
clinical trials in both type 2 diabetes and obesity as planned in
2024.”
Phase 1b Study Results
The Phase 1b MAD study focused on the safety and tolerability of
GSBR-1290 in 24 healthy overweight or obese individuals.
Participants were randomized 3:1 to GSBR-1290 or placebo across
three dose cohorts with target doses of 30mg, 60mg or 90mg.
GSBR-1290 demonstrated reductions in mean body weight ranging up
to 4.9 kg compared to baseline, and up to 4.9%
placebo-adjusted.
Table 1: Percent weight change from baseline to day 28
|
Placebo(n=5) |
GSBR-129030 mg(n=6) |
GSBR-129060 mg(n=6) |
GSBR-129090 mg(n=5) |
% weight changefrom baseline |
-0.5% |
-1.6% |
-5.2% |
-5.4% |
% weight changeplacebo-adjusted(90% CI) |
- |
-1.1%(-3.8 to 1.7) |
-4.6%(-6.6 to -2.7) |
-4.9%(-7.8 to -1.9) |
Exploratory p-valuevs. placebo |
- |
0.494 |
0.002 |
0.013 |
GSBR-1290 demonstrated an encouraging safety and tolerability
profile following once-daily dosing. No participants discontinued
the study drug due to adverse events. The majority of adverse
events reported were mild, with no severe or serious adverse events
observed. As expected for this class, leading adverse events were
gastrointestinal-related, with the two most common adverse events
being nausea and vomiting, with higher incidences observed in the
60 and 90 mg dose cohorts compared to placebo. There were no
clinically meaningful changes in liver function tests.
Table 2: Summary of Treatment Emergent Adverse Events
(TEAEs)
Event, N (%) |
GSBR-1290 30 mg (n=6) |
GSBR-1290 60 mg (n=6) |
GSBR-1290 90 mg (n=6) |
Placebo pooled (n=6) |
Any TEAE |
5 (83) |
6 (100) |
6 (100) |
4 (66) |
Any TEAE bymaximum severity |
|
|
|
|
Mild |
4 (66) |
4 (66) |
3 (50) |
4 (66) |
Moderate |
1 (16) |
2 (33) |
3 (50) |
0 |
Severe |
0 |
0 |
0 |
0 |
Any Serious AdverseEvents |
0 |
0 |
0 |
0 |
Phase 2a Program Update
A data collection omission occurred at a clinical site that
impacted the obesity cohort (120 mg dose level) of the Phase 2a
study, where weight was not collected at the final (week 12) visit
for 24 of the 40 enrolled participants. Other safety and laboratory
assessments were measured at all visits, including the week 12
visit as per protocol. Structure will enroll additional
participants in the Phase 2a obesity cohort to replace those for
whom 12-week weight data was not collected. The replacement
participants will follow the same study protocol, without changes
in the titration schema or target dose (120 mg/QD). As a result,
Structure now plans to report topline data from the obesity cohort
in the first half of 2024. While Structure remains blinded to data
from the Phase 2a obesity cohort, there were no adverse-event
related discontinuations through the end of the study at 12 weeks
for any of the 40 participants in the Phase 2a obesity cohort.
Structure remains on track to report topline data from the type
2 diabetes cohort of the Phase 2a study in the latter half of the
fourth quarter of 2023 as planned, along with results from the
Japanese ethno-bridging study of GSBR-1290.
Phase 2b Studies Planned to Initiate in
2024
Structure continues to plan to initiate two Phase 2b studies of
GSBR-1290 in 2024. The type 2 diabetes study is expected to include
approximately 500 individuals across the United States, Europe and
Japan. The obesity study is expected to include approximately 275
individuals across the United States and Europe.
In preparation for the Phase 2b studies, Structure is also
planning a separate formulation bridging PK study to support the
planned transition from capsules to tablets, which is expected to
initiate in the fourth quarter of 2023 and complete in the second
quarter of 2024. Pending supportive data from this bridging study,
the tablet formulation would be used in future GSBR-1290 studies
starting with the planned Phase 2b studies.
Conference Call and Webcast Information
Structure will host a conference call and webcast today,
September 29, 2023 at 8:30 a.m. Eastern Time. A live webcast of the
call will be available on the Investor Relations page of
Structure’s website at
https://ir.structuretx.com/events-presentations/events. To access
the call by phone, participants should visit this link
(registration link) to receive dial-in details. The webcast will be
made available for replay on the company's website beginning
approximately two hours after the live event. The replay of the
webcast will be available for 90 days.
About the Oral Incretin Metabolic Franchise
GSBR-1290 is an orally-available, small molecule agonist of the
glucagon-like-peptide-1 (GLP-1) receptor, a validated drug target
for the treatment of type 2 diabetes and obesity. GSBR-1290 was
designed through the company’s structure-based drug discovery
platform and is designed to be a biased GPCR agonist, which
selectively activates the G-protein signaling pathway. Beyond
GSBR-1290, Structure is developing next generation combination
GLP-1R candidates, including dual GLP-1R/GIPR agonists and amylin
agonists, each designed with customized properties to achieve
additional benefits.
About Structure Therapeutics
Structure Therapeutics is a leading clinical-stage
biopharmaceutical company focused on discovering and developing
innovative oral treatments for chronic metabolic and
cardiopulmonary 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 Statements
This 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, the
clinical data from Structure’s Phase 1b MAD study for GSBR-1290,
the clinical update from Structure’s Phase 2a study, for GSBR-1290
in patients with type 2 diabetes and obesity, any expectations
regarding the safety, efficacy or tolerability of GSBR-1290 and
other candidates under development, the ability of GSBR-1290 to
treat type 2 diabetes, obesity or related indications, the planned
initiation and study design of Structure’s Phase 2b studies for
GSBR-1290 in patients with type 2 diabetes and obesity and the
timing thereof; the planned timing of the Company’s data results
and continued development of GSBR-1290 and next generation
combination GLP-1R candidates 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 preliminary
nature of the results due to length of the study and sample size,
the risks that unblinded data is not consistent with blinded data,
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 any global pandemics, 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 Annual Report on Form 10-K filed
with the SEC on March 30, 2023, Quarterly Report on Form 10-Q filed
with the SEC on August 10, 2023, and future reports the Company may
file with the SEC from time to time. 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.
Investors:Danielle KeatleyStructure
Therapeutics Inc.ir@structuretx.com
Media:Dan Budwick1ABDan@1abmedia.com
Structure Therapeutics (NASDAQ:GPCR)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Structure Therapeutics (NASDAQ:GPCR)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024