Radella Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced topline results from its Phase 1a study of MD-18, an investigational treatment for obesity and diabetes.
The study evaluated MD-18’s safety, tolerability, and pharmacokinetics.
MD-18 targets protein-tyrosine phosphatase 1B (PTP1B), a therapeutic target supporting glucose homeostasis and energy metabolism. The drug uses a novel peptide approach to specifically target PTP1B, avoiding off-target effects seen with other inhibitors.
The randomised, double-blind, placebo-controlled trial enrolled 35 healthy participants who received a single subcutaneous dose of MD-18 ranging from 40mg to 320mg.
The treatment was well-tolerated at all dose levels, with no serious adverse events or discontinuations.
Mild, transient injection site reactions were the only treatment-related side effects, demonstrating a favourable safety profile.
After seven days, subjects receiving MD-18 showed notable improvements in metabolic parameters, including reduced leptin levels, improved insulin sensitivity, and decreases in alanine aminotransferase (ALT), LDL cholesterol, and total cholesterol. These effects were not seen in the placebo group.
Additionally, participants reported reduced appetite.
Radella Pharmaceuticals founder, chairman, and CEO Daniel Cohen said: “Current obesity treatments primarily focus on appetite suppression without addressing the underlying causes of metabolic dysfunction.
“MD-18’s differentiated mechanism, which has shown promise in improving both insulin sensitivity and additional key metabolic pathways, could potentially offer a new therapeutic option for patients, either as a standalone treatment or in combination with existing therapies.
“Based on these encouraging Phase 1a results, we look forward to advancing our clinical programme to evaluate MD-18’s full therapeutic potential.”
Radella Pharmaceuticals plans to launch a Phase 1b study by the year’s end to further support the clinical development of this investigational MD-18 platform. It will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous doses of MD-18.
The study will include up to 72 subjects, consisting of overweight volunteers and patients with obesity or type 2 diabetes. The trial will evaluate both dose levels and frequency over a four-week period, with an eight-week extension for the obesity and diabetes cohorts.
The biopharmaceutical company is also advancing a pipeline of follow-on assets targeting unmet needs in neurodegenerative diseases and fatty liver disease.
