Aphaia Pharma Publishes Phase 1 and 2 Clinical Data of Oral Formulation in Patients with Obesity and Prediabetes

• Aphaia’s lead formulation orchestrates a comprehensive hormonal response from nutrient-sensing cells with potential to modify the course of obesity and associated metabolic diseases.
• It is currently under evaluation in a Phase 2 trial in individuals with obesity, following positive Phase 2 trial data in patients with prediabetes

ZUG, Switzerland and SAN JUAN, Puerto Rico, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Aphaia Pharma, a clinical-stage company developing precision-targeted drug formulations that harness endogenous enteroendocrine systems to treat obesity and associated metabolic disease, announced today the publication of a peer-reviewed article in Diabetes, Obesity and Metabolism, entitled “Coated glucose microbeads stimulate enteric hormone release and improve glucose tolerance in Phase 1 and 2 clinical trials.”

The article, available here, showcases data from two Phase 1 trials that provide proof-of-concept for the mechanism of action of Aphaia’s lead formulation and from a Phase 2 trial demonstrating clinical efficacy in patients with pre-diabetes. After 6 weeks of treatment with Aphaia’s formulation, glucose handling was significantly improved, as measured with an oral glucose tolerance test (OGTT). Adverse events were infrequent and modest in all three trials.

“This peer-reviewed publication validates our approach and underscores its potential for the treatment of obesity and related diseases,” said Steffen-Sebastian Bolz, M.D., Ph.D., chief scientific officer of Aphaia Pharma. “Unlike incretin mimetics, our approach harnesses nutrient-sensing cells in the gut to elicit a broad and targeted endogenous response, resulting in comparable efficacy with far fewer side effects. We are excited by the efficacy data reported in this article and look forward to the results of our larger Phase 2 study in obese patients that we anticipate will be released in Q3 next year.”  

Christian Sina, M.D., professor of Medicine at University of Luebeck, director of the Institute of Nutritional Medicine at UKSH, Germany, principal investigator of the Phase 2 trial and article co-author, added, “Given the mechanism of action and benign safety profile, this oral formulation presents significant disruptive potential as a sustainable treatment alternative for patients with obesity and related diseases, as proposed in the published article.”

Key highlights from the Phase 1 studies include:

• In individuals with obesity, Aphaia’s formulation achieved targeted release in the distal small intestine, thereby inducing the therapeutically relevant release of a broad spectrum of enteric hormones with very low inter-individual variability; hormones released include glucagon-like-peptide 1 (GLP-1), GLP-2, peptide tyrosine-tyrosine (PYY), glicentin, oxyntomodulin (OXM), and glucose-dependent insulinotropic peptide (GIP).
• The targeted distal release of APH-012 avoids glucose absorption, given the lower abundance and absorptive capacity of glucose transporters in the distal small intestine.
• The hormone release starts 1.5 h after Aphaia’s formulation intake, similar to what’s reported following a meal intake, and lasts for 4-6 hours; this long-lasting effect is associated with the continuous release of glucose from the beads and is key for the therapeutic effect of Aphaia’s formulation.
• Aphaia’s formulation intake triggers peripheral effects as well, including the release of pancreatic insulin and C-peptide, a valuable indicator of metabolic health.

Key highlights from the Phase 2 study include:

• In a post hoc analysis of pre-diabetic patients, treatment with Aphaia’s formulation for 6 weeks improved OGTT glucose level 2h post challenge from 8.72 ± 0.81 to 6.76 ± 1.13 mmol/L (n=12, p= 0.003); placebo had no significant effect in this patient group (8.64 ± 0.84 versus 8.13 ± 1.38 mmol/L; p= 0.247).
• Treatment with Aphaia’s formulation for 6 weeks reduced OGTT area under the curve (AUC 0-120 minutes) from 1261 ± 103 to 1163 ± 80 min*mmol/L (n=12; p= 0.005); the placebo treatment had no significant effect on AUC in this subgroup (1250 ± 98 to 1225 ± 117 min*mmol/L; p= 0.466).

About the Phase 1 trials
The data presented here combine results from two Phase 1 trials designed to assess the pharmacodynamics (PD) and pharmacokinetics (PK) of different bead coating variations, as well as cargo doses, in 20 healthy subjects with obesity after overnight fasting. Venous blood samples for hormone analysis were collected 1 hour and 30 minutes before formulation intake, followed by additional samples every 30 minutes after intake and up to 10 hours post-consumption. For additional information on the study design, refer to NCT05737927 and NCT05713773.

About the Phase 2 trial
The Phase 2 trial (NCT05803772) (EudraCT 2022-003205-29) was a randomized, double-blind, placebo-controlled, multi-center proof-of-concept study that evaluated the safety and efficacy of APHD-012 (12g dose of Aphaia’s oral glucose formulation) in 30 adults with prediabetes, diabetes, or healthy individuals in a cross-over design. Patients were randomized to receive a once-daily dose of either Aphaia’s formulation or a matching placebo for six weeks, followed by a washout period of 4 weeks, and subsequent crossover to the other treatment arm for another 6 weeks. The primary endpoint of the trial was the ability of Aphaia’s formulation improve glucose tolerance in individuals with a pathological oral glucose tolerance test (OGTT) after 6 weeks of administration.

About Aphaia’s oral formulation
Aphaia’s coated glucose formulation is designed to be released at discrete parts of the small intestine, to elicit a comprehensive activation of 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.

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, it is being evaluated in a 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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