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, it has completed enrolment in the second arm of its Phase 2 trial, which is evaluating the safety and efficacy of two separate doses of Aphaia’s formulation, or their respective placebos, twice per day to induce weight loss in individuals with obesity. The company had already completed enrolment in Part 1 of the trial, evaluating a once-daily 12g dose of its oral glucose formulation (APHD-012), in April 2024.
Aphaia’s lead drug candidate is a proprietary oral glucose formulation designed to be released at discrete parts of the small intestine to restore endogenous nutrient-sensing signalling pathways and stimulate the release of the broad spectrum of enteric hormones that control multiple homeostatic functions like appetite, hunger, satiety, glucose metabolism and energy expenditure. This includes glucagon-like-peptide 1 (GLP-1), peptide tyrosine-tyrosine (PYY), glicentin and oxyntomodulin (OXM) among others.
“There is a large unmet need for treatment solutions for patients with obesity beyond hormone replacement therapy. We believe in the potential of our targeted oral glucose formulation to deliver long-term benefits for patients with minimal side effects, given its capacity to restore the endogenous release of the full spectrum of metabolically active hormones involved in satiety and glucose metabolism,” explained Dr Steffen-Sebastian Bolz, chief scientific officer of Aphaia Pharma. “Arm 2 of the trial will further allow us to refine the dosing regimen to optimize treatment response should we confirm an effect of circadian rhythm on treatment efficacy.”
The Phase 2 trial (NCT05385978) is a randomised, double-blind, placebo-controlled, proof-of-concept study assessing the safety and efficacy of Aphaia’s oral glucose formulation in adults with obesity. It is comprised of two arms: Arm 1 includes two cohorts totalling 174 patients randomised to receive a once-daily dose of either APHD-012 (12g of Aphaia’s glucose formulation) or APH-012P, a matching placebo, prior to main daily meals for six (Cohort 1) or twelve months (Cohort 2).
Arm 2 includes four cohorts with a total of 54 additional patients randomized to receive either 6g (APHD-006) or 8g (APHD-008) of Aphaia’s glucose formulation or their respective placebos twice per day. The primary endpoint of the trial is the change from baseline in percent weight compared to placebo. The study will also evaluate exploratory secondary endpoints, which are hallmarks of multiple metabolic diseases closely associated with obesity.