The study has been approved by the U.S. Food and Drug Administration (FDA) and by the German Federal Institute for Drugs and Medical Devices (BfArM) and will be conducted in the USA and Germany.
“We are really excited to continue to evaluate our lead candidate, APH-012, in this Phase 2 trial since it represents a new approach for the treatment of individuals with obesity by addressing the underlying disease pathology,” said Steffen-Sebastian Bolz, M.D., Ph.D., Chief Scientific Officer of Aphaia Pharma. “APH-012 is designed to restore the intestinal hormone response, which is critical for weight control and metabolic balance.”
Kai Deusch, M.D., Ph.D., Chief Medical and Business Officer of Aphaia Pharma, added, “This trial builds on the success of our previous Phase 1 study, which showed that our innovative and novel approach with APH-012 safely induces the endogenous release of the full spectrum of enteric hormones that regulate appetite, energy expenditure and ultimately, weight. The trial will advance throughout the next year with data expected in Q4 2023. In parallel, Aphaia is advancing an extended study program which will test APH-012 in a variety of other clinical conditions related to a dysfunctional intestinal endocrine response.”
Christian Sina, M.D., Principal Investigator of the Phase 2 trial and Director of Nutritional Medicine at the University of Lübeck and the University Medical Center of Schleswig-Holstein, Germany, added, “Individuals with obesity are in need of treatment alternatives that can safely and naturally improve their metabolic health in the long term without having to rely on aggressive surgical procedures or hormone-analogue treatment options that often result in side effects and decreased quality of life, limiting long-term use. The mechanism of action of APH-012 is unique, and I look forward to seeing the results of this new drug modality as part of this Phase 2 trial.”
The Phase 2 trial (NCT05385978) is a randomized, double-blind, placebo-controlled, proof-of-concept study that will evaluate the safety and efficacy of APH-012 in approximately 150 adults with obesity. Patients will be placed in two cohorts and will be randomized to receive a once daily dose of either APH-012 or APH-012P, a matching placebo, prior to main daily meals for 6 months (Cohort 1) or 12 months (Cohort 2). The primary endpoint of the trial is the change from baseline in percent weight compared to placebo.
APH-012 is a 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 like appetite, hunger, satiety and glucose metabolism. This includes glucagon-like-peptide 1 (GLP-1), peptide tyrosine-tyrosine (PYY), glicentin and oxyntomodulin (OXM) among others.
About Aphaia Pharma
Aphaia Pharma is a clinical-stage biopharmaceutical company harnessing proprietary precision-targeted drug delivery technology to restore endogenous hormone release in the gastrointestinal tract to treat and prevent metabolic disorders such as obesity and associated diseases. Aphaia’s lead candidate, APH-012, a glucose formulation, has been shown to safely restore endogenous hormone release in individuals with obesity. APH-012 is now being evaluated in a Phase 2 trial in the U.S. and Germany for chronic weight management and is preparing to be evaluated in a second Phase 2 trial for the improvement of pre-diabetes in individuals with a pathological oral glucose tolerance test (OGTT). The versatile design of Aphaia’s technology platform provides an opportunity for the development of treatments for multiple disease patterns.