Aphaia Pharma Updates Phase 2 Obesity Trial Enrollment and Design

Swiss and Canadian-based Aphaia Pharma, a clinical-stage biopharmaceutical firm, has successfully enrolled participants for the initial phases of its Phase 2 trial. The trial is designed to assess the impact of a daily 12g oral glucose formulation, known as APHD-012, on weight loss for those struggling with obesity. The FDA has granted approval for an expansion of the trial to delve into the role of circadian rhythms in weight management, which will involve an additional four cohorts receiving twice-daily doses of either 6g or 8g of Aphaia’s formulation or placebos.

Aphaia Pharma's strategy includes adjusting the circadian timing to enhance metabolic health and weight regulation. The company's approach is to reset the internal clock and metabolic processes of patients to achieve better long-term health outcomes. Steffen-Sebastian Bolz, the company's chief scientific officer, expressed excitement over the completion of the first two cohorts and the anticipated release of preliminary data by the third quarter of 2024.

The oral glucose formulation developed by Aphaia Pharma is unique in that it aims to restore the body's natural hormone release, which is essential for metabolic balance. This method stands out from traditional obesity treatments, such as hormone replacement therapies, by directly addressing the root cause of metabolic imbalances without the side effects that might hinder long-term treatment.

The Phase 2 trial, registered as NCT05385978, is a randomized, double-blind, placebo-controlled study. It is divided into two arms: the first includes two cohorts with 174 patients who will receive either APHD-012 or a placebo before their main meals for six or twelve months. The second arm will involve an additional 54 patients receiving twice-daily doses of either 6g or 8g of the formulation or placebos. The primary goal is to measure the percentage change in weight from baseline compared to the placebo group. The study will also look into secondary endpoints related to metabolic diseases associated with obesity.

Aphaia’s lead drug candidate works by releasing a formulation in the small intestine to restore nutrient-sensing signaling pathways. This stimulates the release of a range of hormones that control appetite, hunger, satiety, glucose metabolism, and energy expenditure, including GLP-1, PYY, glicentin, and OXM.

Aphaia Pharma, with headquarters in Switzerland, Canada, and Puerto Rico, is focused on developing treatments for metabolic disorders such as obesity and related diseases. The company's technology platform is versatile, offering potential for the development of treatments for a variety of disease patterns.