Aphaia Pharma Completes Enrollment in Arm 2 of Phase 2 Trial in Individuals with Obesity

2024-06-13

临床2期

Enrollment has been completed for the last four cohorts evaluating the contribution of circadian effects in weight loss treatment using Aphaia’s formulation

Topline data anticipated in Q3 and Q4 2024 for Arm 1 and Arm 2 of the trial, respectively

ZUG, Switzerland and SAN JUAN, Puerto Rico and TORONTO, June 13, 2024 (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 that it has completed enrollment 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 enrollment in Part 1 of the trial, evaluating a once-daily 12g dose of its oral glucose formulation (APHD-012), in April.

"We are pleased to have completed enrollment for Arm 2 on schedule, allowing us to report topline data in Q4 2024, following Arm 1 data in Q3 2024,” said Steffen-Sebastian Bolz, M.D., Ph.D., chief scientific officer of Aphaia Pharma. “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. 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 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.

About Aphaia Pharma

Aphaia Pharma is a clinical-stage biopharmaceutical company with headquarters in Switzerland, Canada and Puerto Rico. It harnesses proprietary precision-targeted drug formulations to restore endogenous hormone release from nutrient-sensing cells in the gastrointestinal tract to treat and prevent metabolic disorders such as obesity and associated diseases. Aphaia’s lead drug candidate, an oral glucose formulation, has been shown to safely restore endogenous hormone release in individuals with obesity. It 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.

Aphaia Investor Contact

Günter Jucho

Chief Financial Officer

jucho@aphaiapharma.com

Media Contact

Madelin Hawtin

LifeSci Communications

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