In a thrilling turn of events, San Francisco-based biotech powerhouse Structure Therapeutics experienced a meteoric rise in its shares, surging by an astonishing 70% during premarket trading on Friday. The catalyst behind this exhilarating leap was the announcement of promising Phase Ib results for Structure’s groundbreaking weight-loss drug candidate.
The four-week trial, featuring 24 patients, delivered staggering findings: a remarkable reduction of up to 4.9 kilograms in mean body weight from baseline, accompanied by an impressive placebo-adjusted weight loss of up to 4.9%. While it’s essential to remember that these are early results, they’ve undeniably set the biotech world abuzz with anticipation for more comprehensive data.
Analysts, caught up in the excitement, didn’t hold back their praise, deeming the findings “impressive” and suggesting that Structure’s weight loss drug could emerge as a “highly competitive” challenger to efforts by industry giants Pfizer and Eli Lilly in the quest for an effective weight-loss medication.
Adding to the intrigue, Structure Therapeutics also unveiled a significant development: a $300 million private placement equity financing. The infusion of funds, when combined with existing cash reserves and short-term investments, is expected to extend the company’s financial runway all the way through to the end of 2026.
At the heart of this excitement lies Structure’s investigation of GSBR-1290, a highly selective oral glucagon-like peptide-1 (GLP-1) receptor agonist, in overweight and obese patients. While GLP-1 receptor agonists have traditionally been employed to manage glucose levels in individuals with type 2 diabetes, they are increasingly gaining attention as potential weight-loss solutions.
In a related update, Structure Therapeutics revealed a study delay involving a Phase IIa trial that encompassed 40 patients in the obesity cohort and another 40 in the type 2 diabetes cohort, conducted over a 12-week period. The delay arose from a data collection oversight in 24 patients from the obesity cohort during their final visit.
To ensure the integrity of the study, these 24 participants are being replaced, pushing the reporting of topline results to the first quarter of 2024. However, the type 2 diabetes cohort remains on track to unveil its topline results by the fourth quarter of 2023.
Looking ahead, Structure Therapeutics has an ambitious agenda. The company is gearing up to launch two Phase IIb studies on GSBR-1290, targeting patients with type 2 diabetes and obesity. These studies are expected to enroll a substantial 500 patients and 275 patients, respectively.
To prepare for these pivotal studies, the company is embarking on a separate formulation bridging study, transitioning from capsules to tablets. This transformative study is slated to kick off in the fourth quarter of 2023 and conclude by the second quarter of 2024. The resulting tablet formulation will be instrumental in shaping the future of the type 2 diabetes and obesity studies.
While the demand for GLP-1 receptor agonists continues to soar, these drugs are not without their regulatory challenges. The European Medicines Agency has raised concerns about a potential risk of thyroid cancer in patients taking these medications.
Nevertheless, titans like Lilly and Novo Nordisk are charging ahead, vying for a piece of what could be a staggering $50 billion market by 2030, according to research by Morgan Stanley. The weight loss race is on, and Structure Therapeutics is sprinting toward the finish line with its sights set high.