Aphaia Pharma Announces Dosing of First Patient in its Phase 2 Trial Evaluating its Lead Candidate APH-012 for Prediabetes
ZUG, Switzerland and SAN JUAN, Puerto Rico, April 25, 2023 (GLOBE NEWSWIRE) — 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 the first patient has been dosed in a Phase 2 study evaluating the safety and efficacy of its lead candidate, APH-012, to improve glucose tolerance in patients with prediabetes.
“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, M.D. Ph.D., 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.”
Christian Sina, M.D., Principal Investigator for the Aphaia Phase 2 trial program, added, “Prediabetes is becoming increasingly more common worldwide and typically progresses to manifest type 2 diabetes in a large fraction of patients. There is a high medical need for therapeutic approaches that can help prevent diabetes progression when lifestyle changes, such as diet and exercise, are unable to restore blood glucose to normal levels. I look forward to evaluating APH-012’s unique mechanism of action and its potential to provide a much-needed solution to slow down or even revert prediabetic conditions.”
The Phase 2 trial (NCT05803772) (EudraCT 2022-003205-29) 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.
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 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. The versatile design of Aphaia’s technology platform provides an opportunity for the development of treatments for multiple disease patterns.
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Günter Jucho
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jucho@aphaiapharma.com
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LifeSci Communications
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