Structure Therapeutics (GPCR) investor relations material

Clinical development and pipeline updates

• Phase III ACCOMPLISH-1 and ACCOMPLISH-2 global studies have been initiated, focusing on oral GLP-1 small molecule with a best-in-class profile; recruitment and retention are key priorities.

• Amylin program (ACCG-2671) has entered a phase II-A 12-week multiple ascending dose (MAD) study, with recent data readouts showing promising safety and efficacy signals.

• Additional data readouts are expected in Q4, including body composition, type 2 diabetes, and a switch study from injectable to oral therapy.

• A second amylin molecule and a GLP-1/GIP combination are set to enter the clinic by year-end, with further MAD study results expected in the first half of next year.

• Phase III readout for the oral GLP-1 program is anticipated at the end of 2028.

Market landscape and competitive positioning

• Oral GLP-1 drugs have rapidly gained market share, now accounting for 17% of the GLP-1 space, with projections to reach 50% by 2030.

• Small molecule oral drugs offer advantages in accessibility, affordability, manufacturing, and scalability compared to peptide-based therapies.

• The company is the first to bring an oral amylin small molecule into the clinic, leveraging a structure-based drug discovery platform for competitive advantage.

• A robust IP portfolio has been established for both GLP-1 and amylin programs, aiming to create barriers to entry as competition intensifies.

Key clinical data and trial design insights

• The oral amylin candidate demonstrated a six-day half-life, clean safety profile, and 3.3% weight loss at the 10 mg dose, with positive bone health biomarker changes.

• Safety has been confirmed in a three-month tox study, with ongoing six- and nine-month studies; no serious adverse events or liver toxicity observed.

• The MAD study will explore both daily and weekly dosing, with adaptability in titration schedules to optimize efficacy and tolerability.

• Aleniglipron, the oral GLP-1 candidate, has shown 16% efficacy after eight weeks at the top dose, outperforming peers in the same class.

• Innovative trial designs, including open-label extensions and heat maps, are used to enhance compliance and capture detailed patient journeys.