SOLNA, Sweden – Empros Pharma AB, a clinical-stage biopharmaceutical company pioneering next-generation oral therapies for obesity control, has received approval by the Swedish Medical Products Agency to initiate a new Phase II clinical trial for its lead asset, EMP16. The POEM Trial (Pilot dose-Escalation trial with EMP16), will generate important data to further optimize tolerability and patient adherence in preparation for the upcoming Phase III program.
POEM follows the successful Phase IIb SESAM trial, where 320 participants were enrolled in just one month, highlighting the strong unmet need for affordable, safe and effective oral therapies in obesity. SESAM was the second 6-month trial confirming EMP16’s efficacy and safety, demonstrating meaningful weight loss with a favorable profile versus conventional treatments in regards to overall health gain.
“With SESAM completed and Phase III preparations underway, the POEM trial is a focused study to further refine the patient experience,” says Dr. Ulf Holmbäck, Chief Scientific Officer at Empros Pharma. “We aim to ensure that EMP16 not only works, but is well-tolerated by everyone in everyday life, an essential factor for long-term success in weight management.”
A Smarter Path to Long-Term obesity control
EMP16 is a novel oral, modified-release fixed-dose combination of orlistat and acarbose designed to improve efficacy and reduce common gastrointestinal side effects. Unlike injectable GLP-1 agonists, EMP16 offers a gut-targeted option that supports metabolic health and improved diet, essential for long term obesity control.
The POEM trial will evaluate how nutritional support together with supplemental dietary fiber impacts tolerability during dose escalation of EMP16 in patients who previously experienced gastrointestinal side effects from anti-obesity medications. Empros aims to increase long-term adherence and broaden EMP16’s appeal in real-world use.
On Track for Phase III and Commercialization
The POEM data will help refine the Phase III protocol and support regulatory interactions. EMP16 remains on track for a 2028 launch, aided by existing safety data and prior regulatory feedback.
With rising interest from investors and licensing partners, Empros presents a differentiated, low-risk asset in the rapidly growing global obesity market.