Empros Pharma AB has initiated their third clinical trial for their anti-obesity treatment, EMP16. This is a phase 2b trial and follows an earlier successful Proof-of-concept trial.
Ulf Holmbäck, CSO of Empros commented: “This phase 2b study represent a significant milestone for
Empros. We now leave the early stage clinical development and enter late phase clinical trials with
EMP 16 – our novel modified release combination of acarbose and orlistat”.
The primary objective is to confirm the added effect of acarbose in EMP16 on efficacy compared to
modified release orlistat and Xenical in order to satisfy the Fixed Combination Regulation. Secondary
objectives are to show that the half-dose version of EMP16 has at least the same efficacy as Xenical,
but clearly superior in tolerability. The half dose will also be explored as a potential OTC medication
which could become a very interesting commercial development for EMP16. In parallel to the SESAM
trial, Empros plan to conduct a crossover phase 1 trial in 2023 to confirm the pharmacodynamic and
pharmacokinetic properties of EMP16.
The new trial, SESAM (Study Exploring the Supportive effect of Acarbose in weight Management), is a
6-month, double-blinded trial involving 320 patients with obesity/overweight with co-morbidities.
The CRO running the study, CTC AB, has begun screening and top-line data is expected in Q1 2024.
Empros Pharma develops EMP16, a treatment for obesity planned to be ready for launch in 2027.
EMP16 is unique within the obesity field as safety can be bridged from previous products; i.e., the
required phase 3 program is much smaller compared with all other emerging products. The product
has already demonstrated efficacy in a 6-month clinical trial and will be one of the first obesity drug
products launched after the expected Mounjaro launch. Empros Pharma was founded in 2013 by
researchers and entrepreneurs at Uppsala University with the investor Flerie Invest. The EMP16
product has demonstrated its efficacy in a proof-of-concept clinical trial, as recently published in
Obesity: Effects of a novel weight‐loss combination product containing orlistat and acarbose on
obesity: A randomized, placebo‐controlled trial – Holmbäck et al. Obesity (Silver Spring). 2022
Canaccord Genuity is acting as exclusive business development advisor for EMP16 and organizations
with an interest to commercialize EMP16 are encouraged to contact Issac Jacob at Canaccord.