Aphaia Pharma doses first patient in its Phase 2 trial

Founded in 2018, Aphaia Pharma is a clinical-stage biopharmaceutical company harnessing proprietary precision-targeted drug formulations to restore endogenous hormone release from nutrient-sensing cells in the GI 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 being evaluated in two Phase 2 trials, one for chronic weight management in individuals with obesity and the second to improve glucose tolerance in individuals with prediabetes. Prediabetes is a serious health condition where blood sugar levels are elevated but not yet in the type 2 diabetes range. Prediabetes is becoming increasingly common and affects more than 10% of the population in Europe, the U.S. and Asia. The versatile design of Aphaia’s technology platform provides an opportunity for the development of treatments for multiple disease patterns.

Aphaia has dosed the first patient in phase 2 clinical trial (NCT05803772) (EudraCT 2022-003205-29) run in the US and Germany. The study is a randomized, double-blind, placebo-controlled, multi-center proof-of-concept study that will evaluate the safety and efficacy of APH-012 in approximately 30 adults with prediabetes in a cross-over design. Patients will be randomized to receive a once-daily dose of either APH-012 or APH-012P, a matching placebo, for six weeks. The primary endpoint of the trial is APH-012’s ability to improve glucose tolerance in individuals with a pathological oral glucose tolerance test (OGTT) after 6 weeks of administration.

“We are pleased to continue to evaluate APH-012 in additional indications beyond obesity in the clinic since we believe in the potential of our unique approach to help treat multiple metabolic diseases,” said Kai Deusch, Chief Business & Medical Officer of Aphaia Pharma. “This trial builds on the success of our Phase 1 study, which demonstrated APH-012’s ability to safely induce the release of gut-derived hormones involved in regulating key processes known to be altered in prediabetes, such as glucose tolerance and metabolism, appetite control, and energy expenditure. We look forward to evaluating the results of the trial, which we hope to release by Q4 2023, as they will complement the data of our obesity trial expected to be available by Q1 2024.”

Born global
With its headquarters in Zug, Switzerland, Aphaia has an office in the United States and Canada and has partnered its clinical and commercial supply development and manufacturing with a good manufacturing practice (GMP) certified partner in Puerto Rico. With the CFO based in Switzerland, the startup has a global team in different locations worldwide.

(Press release/RAN)