Radella Pharmaceuticals has announced positive topline results from its Phase Ia trial of MD-18, an investigational therapy for obesity and diabetes. The study assessed the pharmacokinetics, safety, and tolerability of MD-18 in healthy participants, revealing promising metabolic improvements.
Novel PTP1B Inhibitor
MD-18 is a novel peptide designed to target protein-tyrosine phosphatase 1B (PTP1B), a key regulator of glucose metabolism and energy expenditure. Its mechanism of action involves disrupting a specific protein-protein interaction to modulate PTP1B activity, potentially avoiding off-target effects seen with other treatments.
Phase Ia Trial Results
The Phase Ia trial was a randomized, double-blind, placebo-controlled study involving 35 healthy volunteers. Participants received a single subcutaneous dose of MD-18, ranging from 40mg to 320mg. The results indicated that MD-18 was well-tolerated across all dose levels, with no serious adverse events or discontinuations reported.
Notably, subjects treated with MD-18 exhibited consistent metabolic improvements seven days after dosing. These improvements included:
- Reductions in leptin levels
- Enhanced insulin sensitivity
- Decreases in alanine aminotransferase (ALT)
- Decreases in total cholesterol
- Decreases in low-density lipoprotein (LDL) cholesterol
Management Commentary
"Current obesity treatments primarily focus on appetite suppression without addressing the underlying causes of metabolic dysfunction," said Daniel Cohen, CEO, chairman, and founder of Radella Pharmaceuticals. "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."
Future Directions
Radella plans to initiate a Phase Ib study by the end of the year to further investigate MD-18's tolerability, safety, pharmacokinetics, and pharmacodynamics. This study will involve multiple subcutaneous doses administered to up to 72 participants, including individuals with obesity or type 2 diabetes. The Phase Ib trial will explore various doses and dose frequencies over a four-week period, with an eight-week extension planned for specific cohorts.
