Aphaia Pharma has initiated dosing of the first patient in a second Phase 2 clinical trial evaluating its oral glucose-based candidate for obesity treatment, the Swiss/US-based clinical-stage biopharmaceutical company announced. The new trial builds on encouraging initial results from a prior Phase 2 study and aims to further enhance weight loss and metabolic outcomes while preserving the demonstrated low level of adverse effects.
Promising Initial Phase 2 Results Drive Second Trial
The decision to advance to a second Phase 2 trial was informed by results and new mechanistic insights from the earlier Phase 2 study. Key findings from the initial trial demonstrated that Aphaia's oral formulation showed encouraging outcomes suggestive of competitive weight loss while continuing to be well-tolerated and safe in all individuals treated.
"We are very encouraged by the initial results from the first Phase 2 study, which have led us to design this follow-up trial aimed at maximizing our formulation's potential and further enhancing an already competitive and sustainable weight loss effect," said Steffen-Sebastian Bolz, M.D., Ph.D., chief scientific officer of Aphaia Pharma.
Broad Hormone Release Mechanism Confirmed
The treatment induced the release of a broad spectrum of L-cell hormones in all treated individuals, including healthy, pre-diabetic, and diabetic patients. These hormones include glucagon-like-peptide 1 (GLP-1), GLP-2, oxyntomodulin, glicentin, and others that are integral to various bodily functions such as glucose regulation, hunger, and satiety.
Data from the first Phase 2 study continue to confirm the formulation's mechanism of action in restoring hormone release across all treated individuals. The six-month treatment duration suggested potential improvements in structural and functional deficits at the L-cell level, underscoring Aphaia's differentiated approach and the formulation's potential to address the broader pathophysiology basis of the disease.
Targeted Intestinal Delivery System
Aphaia's formulation consists of a coated glucose formulation designed to be released at discrete parts of the small intestine. This targeted delivery system is engineered to restore endogenous nutrient-sensing signaling pathways and stimulate the release of the broad spectrum of enteric hormones that control multiple homeostatic functions, including appetite, hunger, satiety, and glucose metabolism.
The manufacturing process is highly scalable to ensure availability and accessibility, according to the company.
Safety Profile Supports Long-Term Treatment Potential
The formulation continues to demonstrate a benign safety profile, which the company expects will improve patient compliance and adherence to the treatment regime—a key prerequisite for long-term treatment. Bolz noted that this favorable safety profile, combined with the mechanism of action, positions the treatment as a potentially sustainable option for chronic weight management.
Timeline and Future Plans
The second Phase 2 trial is anticipated to be finalized in mid-2026, at which point Aphaia plans to share the complete Phase 2 dataset. The current trial is designed to further enhance weight loss and metabolic outcomes based on the mechanistic insights gained from the initial study.
Aphaia Pharma's versatile technology platform and the broad metabolic effects of its lead formulation provide opportunities for developing treatments for multiple disease patterns beyond obesity, positioning the company to address various metabolic disorders through its precision-targeted drug formulation approach.
