Swiss/US-based clinical-stage biopharmaceutical company Aphaia Pharma has initiated the dosing of the first subject in a second Phase II trial focused on assessing its oral candidate based on glucose for the treatment of obesity.
Building upon insights from a preceding Phase II trial, the current study aims to improve weight loss and metabolic outcomes while maintaining a low incidence of side effects that were previously observed.
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Key findings from the initial Phase II trial revealed that Aphaia Pharma’s oral formulation showed promising weight loss effects and was well tolerated across all subjects.
The treatment was found to trigger the release of a wide array of L-cell hormones, including glucagon-like-peptide 1 (GLP-1), GLP-2, glicentin, and oxyntomodulin, which are integral to various bodily functions such as glucose regulation, hunger, and satiety.
The six-month treatment duration in the earlier trial suggested potential improvements in the structural and functional aspects of L-cells, highlighting the capability of the formulation to combat the complex underlying mechanisms of obesity.
The formulation comprises a coated glucose solution that is released in specific sections of the small intestine.
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By GlobalDataThis process is designed to rejuvenate the body’s intrinsic nutrient-sensing signals and stimulate a comprehensive range of enteric hormones that govern essential homeostatic functions.
The company is developing targeted drug formulations aimed at reactivating natural hormone secretion from nutrient-sensing cells within the gastrointestinal tract for advancing treatments for metabolic disorders, including obesity and its related conditions.
Aphaia Pharma chief scientific officer Steffen-Sebastian Bolz said: “While we await the finalisation of the second Phase II trial, anticipated in mid-2026, and plan to share the complete Phase II dataset, we are pleased to report that data from the first Phase II study continue to confirm our formulation’s mechanism of action in restoring hormone release across all treated individuals, including healthy, pre-diabetic, and diabetic patients.
“It also continues to demonstrate the benign safety profile, which we expect will improve patient compliance and adherence to the treatment regime, a key prerequisite for long-term treatment.”
