Pressrelease Phase 2a trial
Swedish Start-Up Pharma reveals positive Phase 2a trial – results from a novel oral medication treatment of obesity
The Swedish Pharmaceutical start-up Empros Pharma AB has new clinical results from a Phase 2a trial of its first novel and unique product EMP16; an oral drug for the treatment of obesity. It is an innovative, safe, proprietary combination of orlistat and acarbose. The trials show best-in class safety and indicates stronger appetite suppressing effect and improved glycaemic control compared to existing alternatives like Xenical®.
The hunger ratings were reduced in more subjects during 14 days for the EMP16 treatment group compared with the Xenical® treatment group, which suggests a larger body weight reduction for EMP16 compared to Xenical in pivotal long-term studies. The blood glucose concentration after lunch was lower with EMP16 than with Xenical®, which is clinically important. These observations are in line with the proposed gastrointestinal brake effect of EMP16 mediated by modulation of satiety hormones.
The systemic exposure of orlistat was lower for all three doses of EMP16 compared to Xenical®, which emphasizes the unique safety of this product in this treatment class. It is expected that systemic side-effects will be absent for EMP16.
EMP16 has an improved gastrointestinal tolerability than Xenical, which will improve therapy compliance and contribute to improved weight management. It is clear from the recent study that the suspected augmented gastrointestinal originated side effects form the orlistat and acarbose combination is tethered by the novel, proprietary, modified release properties of EMP16.
The appetite supressing effect, the improved glycaemic control and the reduced energy uptake indicates that at least 7% weight reduction as compared to baseline after one year treatment is feasible. The demonstrated superior glycaemic control as compared to Xenical, is reflected in plasma insulin and blood glucose levels and is a strong positive feature of EMP16. These effects also predict the product use in patients with type-2 diabetes.
“Our conclusion is that EMP16 has the potential to become an effective and safe breakthrough product and reach out to a very large global market” says Arvid Söderhäll, CEO of Empros Pharma AB. “Our competitors in Big Pharma are struggling with new injectable products, that are sufficiently effective drugs. The Empros Uppsala team has chosen an incredible smart way; by clever pharmaceutical specialized design we avoid safety pitfalls and we will probably also reach great weight reduction effect. I am very proud to be a part of this.”
Read more of the Phase IIa trial at www.emprospharma.com/phase-2a-trial-concluded/
More information: Arvid Söderhäll, CEO, Empros Pharma, phone: +46 (0)70 723 33 63
The Study: This study a single-centre, controlled, randomized, parallel group Phase 2a study with the primary objective to evaluate the effect after two weeks’ treatment with three different dose combinations of the test formulation EMP16-01 on appetite/tolerability score, as compared to Xenical® (orlistat), measured by questionnaires. A total of 67 subjects with a mean age of 42.9 years and a mean BMI of 34.7 kg/m2 were included and treated, divided into four study arms. Sixty-four (64) subjects completed the study.
EMP16-01: An advanced proprietary innovation of an oral capsule containing a multiple unit, modified release, fixed combination of orlistat and acarbose. The tested dose combinations are (in mg orlistat/acarbose) 60/20, 90/30 and 120/40. Patents are applied for in 75 nations.
Empros Pharma AB: Founded in 2013 and located at Uppsala University and Karolinska Institute Science Park.