US-based biopharmaceutical company Radella Pharmaceuticals has reported topline outcomes from a Phase Ia trial that assessed the pharmacokinetics, safety and tolerability of MD-18, an investigational therapy for obesity and diabetes.
MD-18 is a new peptide targeting protein-tyrosine phosphatase 1B (PTP1B) that is intended to become a key player in glucose regulation and energy metabolism.
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Its mechanism of action involves disrupting a protein-protein interaction to regulate PTP1B, differentiating it from existing treatments by avoiding off-target effects.
The randomised, double-blind and placebo-controlled trial involved 35 healthy participants, who were each given a single subcutaneous dose of MD-18 ranging from 40mg to 320mg.
The results indicated that the therapy was well-tolerated and safe at all dose levels, with no severe adverse events or discontinuations reported.
In addition, subjects who received the treatment showed consistent metabolic improvements seven days after the dose.
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By GlobalDataThese included reductions in leptin levels, enhanced insulin sensitivity, and decreases in alanine aminotransferase (ALT), total cholesterol and low-density lipoprotein (LDL) cholesterol.
Radella Pharmaceuticals CEO, chairman and founder 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 Ia results, we look forward to advancing our clinical programme to evaluate MD-18’s full therapeutic potential.”
Radella is preparing to launch a Phase Ib study by the end of this year to further assess MD-18’s tolerability, safety, pharmacokinetics and pharmacodynamics.
The Phase Ib trial will involve several subcutaneous doses being given to up to 72 individuals, including patients with obesity or type 2 diabetes.
It will explore various doses and dose frequencies over four weeks, with an eight-week extension for specific cohorts.
