GPCR 8-K
Structure Therapeutics Inc. (GPCR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On September 29, 2023, Structure Therapeutics Inc. (the “Company”) issued a press release and will be hosting a conference call and webcast to discuss the results of its Phase 1b multiple ascending dose study of its oral GLP-1 agonist, GSBR-1290, in healthy overweight or obese individuals and provide a program update.
Copies of the press release and investor presentation the Company intends to use during the conference call and webcast are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, respectively.
The information set forth in this Item 7.01 and in the press release and investor presentation attached hereto as Exhibits 99.1 and 99.2, respectively, is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information set forth in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated September 29, 2023. | |
| 99.2 | Investor Presentation, dated September 29, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Structure Therapeutics Inc. | ||
| Date: September 29, 2023 | By: | /s/ Raymond Stevens |
| Raymond Stevens, Ph.D. | ||
| Chief Executive Officer | ||
Exhibit 99.1
Structure Therapeutics Announces Positive Results
from Phase 1b Clinical Study of Oral GLP-1
Receptor Agonist GSBR-1290 and Provides Program Update
GSBR-1290 shown to be generally well-tolerated with no adverse event-related discontinuations in Phase 1b multiple ascending dose study
Significant weight loss at 28 days supporting once-daily dosing
Topline data from Phase 2a type 2 diabetes cohort expected in latter half of fourth quarter 2023; topline data from obesity cohort now expected in the first half 2024
Phase 2b studies in type 2 diabetes and obesity planned for initiation in 2024
Company to host conference call today, September 29 at 8:30 a.m. ET
SAN FRANCISCO – September 29, 2023 – 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-1290 30 mg (n=6) |
GSBR-1290 60 mg (n=6) |
GSBR-1290 90 mg (n=5) | |||||
| % weight change from baseline | -0.5% | -1.6% | -5.2% | -5.4% | ||||
| % weight change placebo-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-value vs. 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 by maximum 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 Adverse Events | 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 Keatley
Structure Therapeutics Inc.
Media:
Dan Budwick
1AB
| GSBR-1290 Phase 1b MAD Results September 29, 2023 |
| Attendees • Raymond Stevens, Ph.D., Chief Executive Officer • Mark Bach, M.D., Ph.D., Chief Medical Officer • Blai Coll, M.D., Ph.D., VP Clinical Development • Jun Yoon, Chief Financial Officer • Danielle Keatley, Investor Relations |
| Forward looking statements This presentation 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 presentation, 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 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 presentation 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. |
| Agenda • Opening Remarks (Ray Stevens) • GSBR-1290 Phase 1b MAD Study Top Line Data (Blai Coll) • GSBR-1290 Program Update and Next Steps (Mark Bach) • Conclusion (Ray Stevens) • Q&A |
| Disrupting the GLP-1R peptide-dominated market with oral small molecules 2005/2010 2014 2017 2019 2021 2022 Our powerful platform enables a franchise approach to potentially replace the marketed peptides GLP-1R GLP-1R/GIPR Peptide Drugs on the Market Incretin drugs evolution – Aimed at improving convenience & clinical efficacy for patients GLP-1R/GIPR GLP-1R/Amylin Lead Optimization GLP-1R GSBR-1290 Phase 2a GLP-1R/GCGR GLP-1R/GIPR/GCGR Hit Identification Our Small Molecules Incretin Franchise Approval: Life Cycle Management |
| Positive results from Phase 1b MAD study and program update • GSBR-1290 (Oral small molecule GLP-1R agonist) demonstrates once-a-day dosing • Topline data from Phase 1b MAD study (4 wk): - Significant weight reduction with once-a-day dosing at 28 days - Encouraging safety and tolerability profile with no adverse event-related discontinuations in Phase 1b multiple ascending dose study • Topline data from Phase 2a study (12 wk): - Type 2 diabetes cohort expected in latter half of fourth quarter 2023 - Obesity cohort expected with capsule to tablet PK/formulation study in 1H 2024 • Phase 2b studies in type 2 diabetes (~26 wk) and obesity (~36 wk) planned for initiation in 2H 2024 |
| GSBR-1290 Phase 1b MAD Study Top Line Data (Blai Coll, M.D., Ph.D., VP Clinical Development) |
| GSBR-1290 Phase 1b MAD study design: Key eligibility criteria Cohort 1 n=8 (6:2) 5 mg 15 mg 30 mg 60 mg Follow up Cohort 3 n=8 (6:2) 0 1 2 3 4 5 weeks 10 mg 30 mg Follow up 0 1 2 3 4 5 weeks Cohort 2 n=8 (6:2) 10 mg 30 mg 60 mg 90 mg Follow up Healthy overweight/obese adult men and women BMI ≥27.0 and ≤40.0 kg/m Age ≥18 and ≤75 years 2 Primary Objectives Safety and Tolerability Secondary Objectives Efficacy – Clinical Activity • Adverse events and tolerability • Safety laboratory • Vital signs and ECG • Change in body weight |
| GSBR-1290 Phase 1b MAD study: Participant disposition GSBR-1290 Phase 1b MAD study Randomized (N=24) GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90mg (N=6) Placebo (N=6) Discontinue study drug due to AE 0 0 0 0 Dose down titrated or hold 0 0 0 0 Completed study 6 (100%) 6 (100%) 5 (83.3%)* 5 (83.3%)* No participants discontinued due to Adverse Events *One participant in 90 mg arm and one in placebo discontinued due to personal travel reasons |
| Mean (SD) Median GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90 mg (N=6) Placebo pooled (N=6) Age, years 49.7 (9.1) 54.5 41.5 (5.4) 43 49.8 (19.9) 48 45.2 (14.6) 41 Sex, female N (%) 2 (33) 4 (66) 2 (33) 5 (83) Weight, Kg 104.6 (19.5) 103.5 93.8 (11.7) 89.1 88.7 (18) 89.8 92.2 (13.3) 90.2 BMI, kg/m2 Mean (SD) 33.2 (3.6) 32 33 (3.2) 33.6 32.1 (3.4) 31.7 31.7 (2.3) 32.2 BMI, kg/m2 =>30, N (%) 5 (83) 5 (83) 5 (83) 5 (83) Heart rate, bpm 71.2 (9.6) 71.5 73.3 (5.2) 75.5 68 (9.3) 67 74.5 (15.5) 74 Glucose, mg/dL 93.3 (3.6) 95 92.7 (10) 93.5 95 (6.4) 96.5 92.2 (3.4) 92.5 • Predominantly female participants, average age 41-49 years • Baseline characteristics consistent across groups, including BMI (31-33 kg/m2) GSBR-1290 Phase 1b MAD study: Baseline characteristics |
| -0.5% -1.6% -5.2% -5.4% -6.0% -5.0% -4.0% -3.0% -2.0% -1.0% 0.0% Placebo 30 mg 60 mg 90 mg % Weight change from baseline to Day 28 GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Positive signs of clinical activity at Day 28 with once-a-day dosing of GSBR-1290 • Changes in body weight (BW) observed at early time points (first week) • Statistically significant reductions in BW (up to 4.9% placebo-adjusted) with QD dosing Placebo GSBR-1290 30 mg GSBR-1290 60 mg GSBR-1290 90 mg % Change in BW placebo-adjusted - -1.1% -4.6% -4.9% 90% CI - -3.8 to 1.7 -6.6 to -2.7 -7.8 to -1.9 P-value vs placebo* - 0.494 0.002 0.013 * Exploratory end point. t test -6 -5 -4 -3 -2 -1 0 0 5 10 15 20 25 30 Weight change from baseline (kg) Study Days Placebo GSBR-1290 30 mg GSBR-1290 60 mg GSBR-1290 90 mg P=0.013 P=0.006 P=0.429 Mean weight change from baseline (kg) Mean weight change from baseline (%) GSBR-1290 |
| GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Changes in mean fasting plasma glucose placebo-adjusted GSBR-1290 30 mg GSBR-1290 60 mg GSBR-1290 90 mg FPG, mg/dL Consistent decrease in fasting plasma glucose (FPG) at ascending doses of GSBR-1290 -8 -7.8 -7.6 -7.4 -7.2 -7 -6.8 -6.6 -6.4 Mean change from Baseline to Day 28 |
| GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Changes in heart rate placebo-adjusted • Higher pulse rate observed with GSBR-1290 as expected for the class • Increases consistent with other GLP-1RAs 1,2 • No dose-dependency observed 1,2 Granhall C, Donsmark M, Blicher TM, et al. Clin Pharmacokinet. 2019;58(6):781-791. Pratt E, Ma X, Liu R, et al. Diabetes Obes Metab. 2023;25:2634–2641. Beats per minute (BPM) 0 5 10 15 20 25 Mean change from Baseline to Day 28 GSBR-1290 30 mg GSBR-1290 60 mg GSBR-1290 90 mg |
| GSBR-1290 Phase 1b MAD study: Safety and Tolerability 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 by maximum 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 Adverse Events 0 0 0 0 • No severe or serious adverse events • Majority of all reported adverse events (50-66%) were mild |
| GSBR-1290 Phase 1b MAD study: Safety and Tolerability Most common TEAEs were GI-related as expected for GLP1-RAs Event, N (%) GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90 mg (N=6) Placebo pooled (N=6) Nausea 1 (16.7) 5 (83.3) 5 (83.3) 0 Vomiting 0 3 (50) 3 (50) 0 Diarrhea 1 (16.7) 3 (50) 3 (50) 0 Abdominal pain 1 (16.7) 0 4 (66.7) 0 Constipation 1 (16.7) 0 2 (33.3) 0 Headache 3 (50) 5 (83) 4 (66.7) 1 (16.7) Mean Change from Baseline to Day 28 ALT, (U/L) Mean (SD) -3.3 (6.5) -5 (8.8) -2.8 (3.5) -1.8 (7) AST, (U/L) Mean (SD) -3.8 (4.1) -2.5 (2.9) -0.6 (4.6) -0.7 (5.7) Symptomatic hypoglycemia 0 0 0 0 • No discontinuations related to GI adverse events • No severe or serious adverse events • Dose-related on target GI effects |
| GSBR-1290 Phase 1b MAD study: Safety and Tolerability Temporal course and severity of nausea 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4 GSBR1290 90 mg mild GSBR-1290 90 mg moderate Placebo 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4 GSBR1290 60 mg mild GSBR-1290 60 mg moderate Placebo 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4 GSBR1290 30 mg mild GSBR-1290 30 mg moderate Placebo 10 mg 30mg 5 mg 15 mg 30mg 60 mg 10 mg 30mg 60mg 90 mg • Lower incidence of nausea in the lowest target dose group (30 mg) • Majority of events mild in severity • Highest incidence observed in the first week for the 60 mg and 90 mg target dose groups GSBR-1290 30 mg Target Dose GSBR-1290 60 mg Target Dose GSBR-1290 90 mg Target Dose |
| GSBR-1290 Phase 1b MAD study: Safety and Tolerability Temporal course and severity of vomiting 0% 10% 20% 30% 40% 50% 60% Week 1 Week 2 Week 3 Week 4 GSBR1290 60 mg mild GSBR-1290 60 mg moderate Placebo 0% 10% 20% 30% 40% 50% 60% Week 1 Week 2 Week 3 Week 4 GSBR1290 90 mg mild GSBR-1290 90 mg moderate Placebo 5 mg 15 mg 30mg 60 mg 10 mg 30mg 60mg 90 mg • 30 mg cohort: No vomiting events • 60 mg cohort: All events accumulated in the first week • 90 mg cohort: Higher incidence of vomiting coinciding with 90 mg up-titration GSBR-1290 60 mg Target Dose GSBR-1290 90 mg Target Dose |
| GSBR-1290: Promising oral small molecule GLP-1R agonist Promising safety and tolerability profile Once-a-day dosing Encouraging weight reduction at 4 weeks GSBR-1290 exhibited encouraging safety and tolerability profile with no adverse event-related discontinuations at all doses at 4wk GSBR-1290 early data of clinical efficacy were observed on a regimen of once daily dosing, taken with food GSBR-1290 demonstrated statistically significant reductions in weight at 60 and 90mg (up to 4.9% placebo-adjusted) |
| GSBR-1290 Program Update and Next Steps (Mark Bach, M.D., Ph.D., Chief Medical Officer) |
| GSBR-1290 Phase 2a study in T2DM and overweight/obese over 12 weeks Cohort 5A (n=18) PBO PBO PBO PBO PBO PBO Follow up Cohort 5B (n=10) 5 mg 10 mg 20 mg 30 mg 45 mg 45 mg X 7 weeks Follow up Cohort 5C (n=26) 5 mg 15 mg 30 mg 60 mg 90 mg 90 mg X 7 weeks Follow up 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 weeks N=54 Primary endpoint: Safety and tolerability Secondary endpoints**: Demonstrate decrease in HbA1c Demonstrate decrease in weight Demonstrate dose response in decrease in HbA1c and weight Primary endpoint: Safety and tolerability (N=~64) Secondary endpoint**: Demonstrate decrease in weight (N=~40) N=40 + 24 replacement participants Cohort 4 5 mg 15 mg 30 mg 60 mg 90 mg 90 mg 120 mg Follow up 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 weeks PBO PBO PBO PBO PBO PBO PBO Follow up (n=24) (n=16) Enrollment completed Top-line 12-week study results anticipated in latter half Q4 2023 Enrolling 24 new participants Top-line 12-week study results anticipated in 1H 2024 Type 2 Diabetes Healthy Overweight/Obese |
| GSBR-1290: Program progress and upcoming milestones 2023 2024 Phase 1b/MAD data (4 wk) • N=24, healthy overweight/obese participants, up to 90 mg • No adverse event-related discontinuations up to 90 mg • Statistically significant reductions in weight at 60 and 90 mg (up to 4.9% placebo-adjusted) Phase 2a T2D data (12 wk) • N=54, T2D participants, up to 90 mg • Results anticipated in latter half of Q4 2023 Japan PK/ethno-bridging study (4 wk) • N=18 healthy adult Japanese and non-Japanese participants, up to 60 mg • Results anticipated in latter half of Q4 2023 Phase 2a Obesity data (12 wk) • N=40 participants, up to 120 mg • Enrolling 24 replacement participants • Completion anticipated in 1H 2024 Capsule to tablet PK/Formulation study (12 wk) • Approximately 45 participants, up to 120 mg • Initiation planned in Q4 2023 • Completion anticipated in Q2 2024 Phase 2b T2D clinical trial (~26 wk) • Approximately 500 participants in US, Europe and Japan • Initiation planned in 2H 2024 Phase 2b Obesity clinical trial (~36 wk) • Approximately 275 participants in US and Europe • Initiation planned in 2H 2024 |
| Closing (Raymond Stevens, Ph.D., CEO) |
| Next steps: Continue to execute on oral incretin franchise strategy GSBR-1290 (Oral GLP-1R) GLP-1R+ Combo (GLP-1R/GIPR) GLP-1R+ Combo (GLP-1R/Amylin) 2023 2024 Phase 1b/MAD data (4 wk) Phase 2a T2D data (12 wk) JP PK/ethno-bridging study (4 wk) Phase 2a Obesity data (12 wk) Capsule to tablet PK/bridging study (12 wk) Initiate Phase 2b T2D study (~26 wk) Initiate Phase 2b Obesity study (~36 wk) Small molecule dual GLP-1/GIPR hits identified and lead optimization underway Small molecule dual agonist GLP-1/GIPR Development Candidate Small molecule Amylin hits identified and lead optimization underway Small molecule Amylin receptor agonist Development Candidate |
| Thank you! CONTACT US FOR ADDITIONAL INFORMATION: Email: [email protected] http://www.structuretx.com |
