According to the biopharma firm, this news brings its therapy for long-term weight management another ‘critical’ step closer to market.
Arvid Söderhall, CEO of Empros Pharma, 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. While it’s clear that some weight loss drugs in the market can help patients lose considerable body weight, these are not silver bullets.
“Not all patients tolerate these drugs due to side effects such as nausea and vomiting while others may be anxious about taking injections or systemic drugs. Also, these medications are costly and a large number of patients have to pay for them out of pocket.”
Empros has now set its sights on a phase 3 trial, with clinical data expected in 2026 and a potential product launch anticipated for 2027.
Patients in the trial lost at least 10% of their body weight, with some losing up to 23% and the average weight loss close to 8%.
EMP16 also demonstrated a well-known safety profile as well as manageable tolerability.
Söderhall adds: “Obesity is a chronic disease, and just as blood pressure increases when you stop taking blood pressure medication, the patients’ weight and the accompanying health problems are likely to quickly return when they stop taking weight loss drugs.
“This is where EMP16 comes in. It not only has a well-established safety and tolerability profile, but it will be economically sustainable for patients to take over the long-term. Furthermore, EMP16 inherently stimulates a behavioural component as consuming a low fat/low carb diet will mitigate side effects.
“It fulfils the unmet need for a product that patients can take for long periods to successfully manage their weight. Our phase 2 data support our ambitions for EMP16 to become a very significant drug in the expanding portfolio of pharmaceutical treatments.”