Full Press Release Details
Structure Therapeutics Reports Positive Topline
Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290
GSBR-1290 achieved a clinically meaningful and
statistically significant placebo-adjusted mean weight loss of 6.2% (p<0.0001) in the Phase 2a obesity study and up to 6.9% (p<0.0001)
in capsule to tablet PK study, in both cases at 12 weeks
GSBR-1290 demonstrated generally favorable safety
and tolerability results
with low AE-related study discontinuations
Pharmacokinetic data support dose proportional
exposure and once-daily oral dosing of GSBR-1290
36-week Phase 2b study in obesity on track to
begin in the fourth quarter of 2024
Company to host conference call today at 8:30
SAN FRANCISCO - June 3, 2024 - 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 12-week topline obesity data from its Phase 2a study of GSBR-1290, along with positive
topline results from its capsule to tablet PK study. Both studies achieved their primary and secondary objectives.
Topline Results Summary
1 Least-squares means and analyzed based on primary
efficacy estimand using a Mixed Model for Repeated Measures
"These topline results demonstrate the substantial weight loss
effect of GSBR-1290 and its potential to become a best-in-class oral small molecule GLP-1RA as well as an ideal backbone for future combination
therapeutics for the treatment of obesity and related diseases," said Raymond Stevens, Ph.D., Founder and CEO of Structure. "We
designed GSBR-1290 to be dosed once-a-day, and are pleased to see the competitive treatment effect at 12 weeks, dose proportional exposure
and target engagement over 24 hours."
Dr. Stevens continued: "We are pleased that our new tablet
performed well and that a start low and go-slow titration strategy proved beneficial and we will carry these observations into our planned
Phase 2b study. As previously reported, we believe our large safety window will allow us the option to explore higher doses in future
studies. As a non-peptide small molecule, our large-scale manufacturing process is expected to be more than capable of meeting the anticipated
global demand of a product with the profile of GSBR-1290. We are excited to move into a Phase 2b study in overweight and obese individuals.
"By 2030, the global prevalence of obesity is expected to reach
1 billion. There is a need for oral treatments, including small molecules, which are easier to make at scale, more stable thus easier
to transport and store, and more cost-effective," said Ania Jastreboff, M.D., Ph.D., Associate Professor of Medicine and Pediatrics
at Yale School of Medicine; Director, Yale Obesity Research Center (Y-Weight), and co-Director of the Yale Center for Weight Management.
"All these factors may enable greater treatment reach for this worldwide disease. The phase 2 data with GSBR-1290 demonstrate safety
to date and clinically meaningful weight reduction with 12 weeks of treatment and are encouraging for its development as a potential future
therapeutic for obesity."
GSBR-1290 Phase 2b Obesity Study Expected to Begin in Fourth Quarter
Structure plans to submit an IND to the FDA in the third quarter of
2024 to support initiation of trials in chronic weight management and thereafter initiate a Phase 2b obesity study of GSBR-1290 in the
fourth quarter of 2024. The 36-week global study is expected to use the tablet formulation of GSBR-1290 and include approximately 300
participants to be treated with multiple doses and dose titration regimens.
About the Phase 2a Study of GSBR-1290 in Obesity
The double-blind, 12-week placebo-controlled Phase 2a clinical trial
enrolled 64 healthy overweight or obese participants that were randomized to GSBR-1290 120mg (n=37) or placebo (n=27), dosed once daily
with weekly dose titrations.
About the GSBR-1290 capsule to tablet PK study
The 12-week placebo-controlled capsule to tablet PK study (n=54) was
designed to evaluate the tolerability, safety and pharmacokinetics of a new tablet formulation of GSBR-1290 and assess three different
dosing and titration regimens, while exploring changes in weight during the 12-week duration. Based on the results with the new tablet
formulation, Structure anticipates using the tablet formulation for future studies starting with the planned 36-week Phase 2b obesity
Conference Call and Webcast Information
Structure will host a conference call and webcast today, June 3,
2024 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 GSBR-1290 and Structure's Oral 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 mellitus (T2DM) and obesity. Through the Company's
structure-based drug discovery platform, GSBR-1290 was designed to be a biased GPCR agonist, which selectively activates the G-protein
signaling pathway. Structure has completed a Phase 2a study of GSBR-1290 in participants with obesity or who are overweight and T2DM with
high body mass index (BMI) 27. A Phase 2b study in obesity is expected to start in the fourth quarter of 2024, and the Phase 2 development
plan in T2DM is expected to be determined in the second half of 2024. Beyond GSBR-1290, Structure is developing next generation combination
GLP-1R candidates together with GIP, amylin, glucagon and apelin oral small molecules.
About Structure Therapeutics
Structure Therapeutics is a science-driven
clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule 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 robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small
molecule compounds designed to surpass the manufacturing scalability 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 potential to become a best-in-class oral small molecule GLP-1RA
as well as an ideal backbone for future combination therapeutics for the treatment of obesity and related diseases, any expectations regarding
the safety, efficacy, tolerability or once-daily dosing of GSBR-1290, including based on the clinical update from the Company's
Phase 2a obesity study and capsule to tablet PK study, and other candidates under development, the ability of GSBR-1290 to treat T2DM,
obesity or related indications, the planned IND submission and initiation and number of expected patients of the Company's Phase
2b obesity study and Phase 2 development plan in T2DM and the timing thereof, respectively and the planned timing of the continued development
of GSBR-1290. 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, efficacy, 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 topline results that the Company reports is based on a preliminary
analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical
trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results
due to length of the study and sample size and results from earlier clinical trials not necessarily being predictive of future results,
including the results using the LSM and mixed model for repeated measures which uses all available data, including data
from patients who did not follow-up at 12 weeks, and estimates how patients with missing data would have responded based on patients who
continued the study and had similar baseline characteristics (implicit imputation), potential delays in the IND submission or commencement,
enrollment and completion of the Company's planned Phase 2 trials, including the Company will need to receive allowance from the
FDA to proceed before initiating the planned Phase 2b trial, 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,
competitive products or approaches limiting the commercial value of the Company's product candidates, the timing and results of