Reported positive results from aleniglipron Phase 2 ACCESS II study
with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs
at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs
Data from ACCESS OLE expected in Q3 2026;
Data from the Body Composition and Type 2 Diabetes/Obesity data expected in Q4 2026
Positive end-of-Phase 2 feedback received from FDA;
aleniglipron Phase 3 initiation on track for Q3 2026
Initial data from Phase 1 single ascending dose (SAD) study of
oral small molecule amylin receptor agonist ACCG-2671 and
initiation of multiple ascending dose (MAD) study expected in Q3 2026;
Phase 1 initiation of second oral amylin candidate ACCG-3535 expected in Q4 2026
Aleniglipron, amylin and combination data to be presented
at the
Cash, cash equivalents and short-term investments of
“With positive end of Phase 2 feedback received from the FDA for aleniglipron, we are well positioned to start our Phase 3 registrational program for chronic weight management in the third quarter,” said
Recent and Upcoming Milestones
Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight
In
- The Phase 2 ACCESS II study demonstrated a placebo-adjusted mean weight loss of 16.3% (39 Ibs; p<0.0001) at the 180 mg dose and 16.0% (37 Ibs; p<0.0001) at the 240 mg dose at 44 weeks.
- The ongoing ACCESS OLE study achieved continued weight loss up to 16.2% (40.5 lbs) observed with 120 mg dose at 56 weeks.
- No weight loss plateau was observed in any of the studies.
Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to report topline results from the ACCESS OLE and Body Composition studies in Q3 and Q4 2026, respectively.
The Company received positive end-of-Phase 2 feedback from the
The Company is also conducting supplementary studies to enhance the competitive profile of aleniglipron, including:
- Ongoing study of ACCESS OLE to evaluate the tolerability profile of the dosing regimen starting at the 2.5 mg dose for those previously on placebo and to collect up to 72 weeks of data exposure to aleniglipron, including 180 mg dose. Data are expected in Q3 2026.
- Ongoing Body Composition study to assess the effect of aleniglipron on body fat loss over a 44-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. These data will be used to inform the size of a sub study into the Phase 3 program. Data are expected in Q4 2026.
- Ongoing 30-week study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron to evaluate the potential for including participants with T2DM in the Phase 3 obesity program. Data are expected in Q4 2026.
- Ongoing SWITCH study to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. Data are expected in Q4 2026.
Oral Small Molecule Amylin Receptor Agonists
- In
December 2025 , the Company advanced ACCG-2671 into a Phase 1 clinical study as the industry’s most advanced oral small molecule amylin therapy for the treatment of obesity. ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect of single ascending doses in healthy adult participants with data anticipated in 2H 2026. In addition, the Company expects to initiate a multiple ascending dose (MAD) study in Q3 2026. - In
November 2025 , the Company declared a second oral small molecule dual amylin calcitonin receptor agonist development candidate, ACCG-3535. ACCG-3535, which is a unique chemical structure compared to ACCG-2671, demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats. Combination therapy with semaglutide (both concurrently and as a subsequent add-on to semaglutide) resulted in superior weight loss compared to semaglutide or ACCG-3535 monotherapy. The Company expects to initiate a Phase 1 clinical study of ACCG-3535 in Q4 2026.
Multiple presentations at
Details of the presentations are as follows:
Title: ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight
Session: Oral Presentations - Human Studies in Obesity Treatment: Emerging Therapeutic Options and Strategies for Decision-Making (1032-OR)
Speaker:
Date:
Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial
Session:
Date:
Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials
Session: Late Breaking Poster Session (3101-LB)
Date:
Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs
Session: Late Breaking Poster Session (3061-LB)
Date:
Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists
Session: Late Breaking Poster Session (3062-LB)
Date:
Additional information about the
First Quarter 2026 Financial Highlights
Cash Position: Cash, cash equivalents and short-term investments totaled
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were
Net Loss: Net loss for the first quarter of 2026 totaled
About Aleniglipron and Structure Therapeutics’ Oral Metabolic Franchise
Aleniglipron (GSBR-1290) is an investigational orally-available, small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics’ structure-based drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. Beyond aleniglipron,
About
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 expected timing of ACCESS OLE and Body Composition studies data readouts; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase 1 study of ACCG-2671; the planned initiation of the ACCG-3535 Phase 1 study and the timing thereof; the belief that data to date from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies support and inform aleniglipron advancement into Phase 3 clinical development; the Company’s anticipated cash runway and uses of cash; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases "anticipated," "believe," "expect," "potential," "to be," "will," 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 topline results that the Company reports are based on 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 the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company's planned Phase 3 clinical program and other clinical studies; disruptions to the operations of the FDA or other
Investors:
212-915-2577
cdavis@lifesciadvisors.com
ir@structuretx.com
Media:
1AB
Dan@1abmedia.com
| Condensed Consolidated Statements of Operations | ||||||||
| (unaudited) | ||||||||
| (In thousands) | ||||||||
| THREE MONTHS ENDED | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 66,507 | $ | 42,867 | ||||
| General and administrative | 22,872 | 13,444 | ||||||
| Total operating expenses | 89,379 | 56,311 | ||||||
| Loss from operations | (89,379 | ) | (56,311 | ) | ||||
| Interest and other income, net | 13,601 | 9,576 | ||||||
| Loss before provision for income taxes | (75,778 | ) | (46,735 | ) | ||||
| Provision for (benefit from) income taxes | 190 | 98 | ||||||
| Net loss | $ | (75,968 | ) | $ | (46,833 | ) | ||
| Research and development | $ | 5,101 | $ | 2,699 | ||||
| General and administrative | 6,538 | 3,219 | ||||||
| Total share-based compensation | $ | 11,639 | $ | 5,918 | ||||
| Condensed Consolidated Balance Sheet Data | |||||||
| (unaudited) | |||||||
| (In thousands) | |||||||
| 2026 | 2025 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash, cash equivalents and short-term investments | $ | 1,458,504 | $ | 1,446,197 | |||
| Prepaid expenses and other current assets | 32,094 | 124,106 | |||||
| Total current assets | 1,490,598 | 1,570,303 | |||||
| Property and equipment, net | 6,365 | 6,653 | |||||
| Operating right-of-use assets | 5,606 | 6,245 | |||||
| Other non-current assets | 5,555 | 717 | |||||
| Total assets | $ | 1,508,124 | $ | 1,583,918 | |||
| Liabilities and shareholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 7,822 | $ | 13,864 | |||
| Accrued expenses and other current liabilities | 46,553 | 46,543 | |||||
| Operating lease liabilities, current portion | 2,609 | 2,878 | |||||
| Total current liabilities | 56,984 | 63,285 | |||||
| Operating lease liabilities, net of current portion | 3,183 | 3,609 | |||||
| Other non-current liabilities | 863 | 647 | |||||
| Total liabilities | 61,030 | 67,541 | |||||
| Total shareholders’ equity | 1,447,094 | 1,516,377 | |||||
| Total liabilities and shareholders’ equity | $ | 1,508,124 | $ | 1,583,918 | |||
Source: