- The POEM study demonstrated an improved tolerability profile in patients taking EMP16 together with dietary support
- Strong efficacy from Phase 2a (LEAAP) and Phase 2b (SESAM) trials, combined with the tolerability data from POEM positions EMP16 as a promising weight-loss maintenance therapy
- Weight-loss maintenance has no approved therapeutics and represents a >$100B market
Empros Pharma AB, a Stockholm-based biopharmaceutical company developing EMP16, an investigational oral fixed dose combination of orlistat and acarbose for obesity and long-term weight-loss maintenance, is pleased to announce positive topline results from its Phase 2 POEM study. The POEM results showed an improved tolerability profile in patients taking EMP16 when administered with appropriate dietary guidance.
Completion of the POEM trial, together with the robust weight-loss efficacy demonstrated in the SESAM and LEAAP trials (~8% at 6 months), represents an important milestone in the development of EMP16 as a sustainable, long-term weight-loss maintenance therapy designed for the prevention of weight regain following pharmacologically induced weight loss. Empros plans to advance EMP16 into a Phase 2 proof-of-concept trial in the weight-loss maintenance setting.
Opportunity for EMP16 in Weight-Loss Maintenance
Despite the availability of GLP-1s for weight loss, up to 80% of patients discontinue anti-obesity medications (AOMs) within two years and, on average, subsequently regain approximately two-thirds of the weight they had lost. With no approved therapeutic options for weight-loss maintenance, physicians face challenges in managing patients who wish to discontinue their prescribed AOMs. Consequently, the weight-loss maintenance segment represents a substantial unmet medical need and a market opportunity exceeding $100 billion. EMP16’s safety demonstrated in the POEM trial, together with strong weight loss findings from prior studies, highlight EMP16’s potential to address this critical gap in long-term weight management.
Arvid Söderhäll, CEO of Empros Pharma, commented:
“The obesity field is undergoing a revolution with the advent of incretin-based therapies. However, long-term weight-loss maintenance remains a major unmet need. EMP16 checks all the boxes for sustainable, long-term treatment — proven safety, lifestyle support, tolerability, oral convenience, and affordability.”
About the POEM Study
The POEM study (“Pilot Dose-Escalation study with EMP16 in Preparation for Phase III”) was a 5.5-week, single-blinded Phase 2 trial (N = 39) designed to investigate dietary support strategies and dose escalation of EMP16.
The data demonstrates that when patients receive appropriate dietary support, there is an improvement in the tolerability profile for both EMP16 and conventional orlistat.
About Empros Pharma
Empros Pharma was founded in 2013 by researchers and entrepreneurs at Uppsala University with the investor Flerie Invest.
www.emprospharma.com
For BD/partnering enquiries:
Back Bay Life Science Advisors has been retained by the company to explore investment opportunities or strategic partnerships for EMP16. Interested parties should direct inquiries to: Vasilios M. Kofitsas, Partner and Managing Director, at info@bblsa.com