Aphaia Pharma Initiates Second Phase 2 Trial of Oral Candidate in Obesity

• Second Phase 2 trial builds on encouraging initial results from a prior Phase 2 study
• Aphaia’s formulation activates gastrointestinal nutrient-sensing signaling pathways to modify the course of obesity and associated metabolic diseases

ZUG, Switzerland, SAN JUAN, Puerto Rico and TORONTO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Aphaia Pharma, a clinical-stage company harnessing precision-targeted drug formulations to restore endogenous endocrine balance for the treatment of obesity and associated metabolic diseases, today announced that it has dosed its first patient in a second Phase 2 study evaluating its lead oral glucose-based candidate in individuals with obesity.

Informed by results and new mechanistic insights from an earlier Phase 2 study, the current trial is designed to further enhance weight loss and metabolic outcomes, while preserving the already demonstrated remarkably low level of adverse effects.

“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. “While we await the finalization of the second Phase 2 trial—anticipated in mid-2026—and plan to share the complete Phase 2 dataset, we are pleased to report that data from the first Phase 2 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.”

Data highlights from the previous Phase 2 trial include:

• Aphaia’s oral formulation demonstrated encouraging outcomes suggestive of competitive weight loss, while continuing to be well-tolerated and safe in all individuals treated.
• Treatment induced the release of a broad spectrum of L-cell hormones (e.g., GLP-1, GLP-2, oxyntomodulin, glicentin, etc.) in all treated individuals, including healthy, pre-diabetic, and diabetic patients.
• The data suggest that treatment for 6 months may improve 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.
  

About Aphaia’s Oral Formulation
Aphaia’s formulation is a coated glucose formulation designed to be released at discrete parts of the small intestine 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. This includes glucagon-like-peptide 1 (GLP-1), GLP-2, peptide tyrosine-tyrosine (PYY), glicentin, and oxyntomodulin (OXM), among others. Its manufacturing process is highly scalable to ensure availability and accessibility.

About Aphaia Pharma
Aphaia Pharma is a Swiss/US-based clinical-stage biopharmaceutical company harnessing proprietary precision-targeted drug formulations to restore endogenous hormone release from nutrient-sensing cells in the gastrointestinal tract to treat and prevent metabolic disorders such as obesity and associated diseases. Aphaia’s lead candidate, an oral glucose formulation, has been shown to safely restore endogenous hormone release in individuals with obesity. After initial positive data in prediabetes patients and a Phase 2 study in obesity, it is being evaluated in a second Phase 2 trial for chronic weight management in individuals with obesity. The versatile design of Aphaia’s technology platform and broad metabolic effects of its lead formulation provides an opportunity for the development of treatments for multiple disease patterns.

Aphaia Investor Contact
Günter Jucho
Chief Financial Officer
jucho@aphaiapharma.com

Media Contact
Madelin Hawtin
LifeSci Communications
AphaiaPharma@lifescicomms.com

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