Swedish biopharma Empros Pharma will dose the first subjects with its obesity combination therapy in a Phase III trial before the end of 2024, according to the company’s CEO Arvid Söderhall.
Söderhall told the Clinical Trials Arena that the company will likely be conducting two Phase III trials, one in patients with obesity and one in patients with obesity and type 2 diabetes, both of which will be held in the US, with plans to deliver data in 2026.
The announcement comes days after the company reported positive topline data from a Phase IIb trial of the combination therapy EMP16, a fixed dose combination of lipase inhibitor orlistat and glucosidase/amylase inhibitor acarbose.
Söderhall said: “Obesity is a complex chronic condition and it is amazing to be part of such huge advancements in a field where there is a clear unmet medical need. We’re very confident in our topline data, with our trials already demonstrating efficacy, safety, and tolerability.”
The Phase IIb SESAM study (NCT05934110) was a six-month, double-blinded trial involving 320 patients with obesity or those who were overweight with risk factors.
The data builds on previous proof-of-concept trial data and shows that a third of patients on EMP16 lost at least 10% of their body weight, with some responders losing up to 23%. The average weight loss was close to 8%. EMP16 also demonstrated a well-known safety profile as well as manageable tolerability.
The company has already held four trials of the candidate which have demonstrated efficacy, safety, and tolerability, and has met stringent FDA regulations for fixed-dose combinations.
If successful at Phase III, Empros Pharma hopes to launch the candidate in early 2027. Söderhall acknowledges that glucagon-like peptide-1 agonists (GLP1-RA’s) therapies are dominant in the obesity market but says that they provide quick weight loss which patients frequently relapse from.
In contrast, Söderhall says that EMP16 provides weight loss management, making it easier for patients to maintain weight loss. As a result, it could be used as a second-line therapy for obesity.
Obesity landscape
In 2022, the World Health Organization (WHO) 2.5 billion adults were classified as overweight with 890 million classified as obese. Obesity is associated with various comorbidities, including cardiovascular disease, diabetes mellitus, osteoarthritis, and gallbladder disease.
The obesity market is currently dominated by Novo Nordisk and Eli Lilly’s GLP1-RAs Wegovy and Zepbound, respectively.
GlobalData predicted the obesity market in 2023 to have been worth $7.7bn.
GlobalData is the parent company of Clinical Trials Arena.
