Aphaia Pharma: Enrollment for Phase 2 trial in individuals with obesity

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 completed enrollment in its Phase 2 trial evaluating the safety and efficacy of a once-daily 12g dose of its oral glucose formulation (APHD-012) to induce weight loss in individuals with obesity. The company also announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the trial’s protocol to further explore the contribution of circadian effects in weight loss treatment. The new protocol will include four additional cohorts, which will be dosed with either 6g (APHD-006) or 8g (APHD-008) of Aphaia’s formulation or their respective placebos twice per day.

With the expansion of the protocol, Aphaia aims to leverage the beneficial effects of circadian timing, which are known to improve metabolic diseases and weight control. Part of the strategy is to readjust the patient’s internal clock and metabolism to optimize long-term therapeutic outcomes for patients.

"We are delighted to have finalized enrollment of the two first cohorts and look forward to releasing topline data from this first part of the study by Q3 2024," said Steffen-Sebastian Bolz, M.D., Ph.D., chief scientific officer of Aphaia Pharma. "In addition, we are excited to have received approval to move forward with the twice-daily protocol of our oral glucose formulation as it will enable us to evaluate whether treatment administration aligned with circadian principles can potentially optimize treatment performance and further enhance long-term benefit for patients.”

Aphaia’s oral glucose formulation distinguishes itself from conventional obesity treatments, such as hormone replacement therapies, through its capacity to restore the endogenous release of the entire spectrum of metabolically active hormones. By directly correcting the underlying pathomechanism to restore physiological balance, it offers the potential to provide a much-needed solution for chronic management of weight loss without the side effects that may restrict long-term treatment with current options.

The Phase 2 trial (NCT05385978) is a randomized, 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 totaling 174 patients randomized 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.

About Aphaia’s drug candidate
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 signaling 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.