Structure Therapeutics (NASDAQ: GPCR) has reached a significant milestone in its obesity treatment program with the completion of enrollment in two pivotal clinical trials for aleniglipron, marking a major step forward in the development of oral alternatives to injectable weight loss medications.
The company has successfully enrolled over 300 patients across its ACCESS and ACCESS II studies, positioning aleniglipron as the second most advanced oral GLP-1 small molecule in development. The ACCESS study includes approximately 220 adults living with obesity or overweight with weight-related comorbidities, evaluating doses up to 120 mg. The ACCESS II trial, involving about 80 patients, will investigate higher doses of 180 mg and 240 mg, both utilizing optimized 4-week titration schedules.
"We believe 2025 will be a transformative year for all oral selective GLP-1 small molecules in obesity and related diseases to address making these medicines more accessible to all," said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. "Structure Therapeutics is well-positioned as a leader with aleniglipron as the second most advanced oral GLP-1 small molecule with 36-week data by year-end and a potential best-in-class profile that is combinable with other medicines."
Expanding the Obesity Treatment Portfolio
Beyond aleniglipron, Structure Therapeutics is advancing ACCG-2671, its oral small molecule amylin receptor agonist. The compound has demonstrated promising preclinical results, showing robust in vivo efficacy and favorable pharmacokinetics supporting once-daily oral dosing. The company plans to initiate Phase 1 clinical studies by the end of 2025.
Dr. Blai Coll, Chief Medical Officer, emphasized the strategic importance of these developments: "Our top priority is execution of ACCESS and ACCESS II clinical studies, and we're excited to announce the completion of enrollment in both studies, which speaks to investigator and patient enthusiasm for aleniglipron."
Strong Financial Position Supports Development
Structure Therapeutics maintains a robust financial foundation with $883.5 million in cash, cash equivalents, and short-term investments as of December 31, 2024. This financial position is expected to fund operations and key clinical milestones through at least 2027, including preparations for Phase 3 studies of aleniglipron.
The company's R&D expenses reached $108.8 million for 2024, reflecting increased investment in clinical programs and personnel expansion to support development efforts. Despite a net loss of $122.5 million for the year, the substantial cash reserves provide a strong runway for advancing their pipeline of oral metabolic disease treatments.
Pipeline Expansion and Future Directions
Structure Therapeutics is simultaneously developing several other promising candidates, including oral small molecule programs targeting GIPR, GCGR, and APJR pathways. The APJR agonist ANPA-0073 has already completed Phase 1 studies with favorable tolerability results, and long-term toxicology studies are expected to conclude in 2025.
This comprehensive approach to developing oral alternatives for obesity treatment positions Structure Therapeutics at the forefront of addressing the growing global obesity crisis with more accessible therapeutic options. The company's progress in 2024 and strong financial position suggest a promising trajectory for their innovative drug development programs.
