Radella Pharmaceuticals reveals promising Phase 1b trial results for MD-18, showcasing significant weight loss and cardiometabolic health improvements.
Radella Pharmaceuticals announced its Phase 1b clinical trial of MD-18 achieved significant weight loss along with cardiometabolic improvements amongst participants. MD-18 targets obesity and type 2 diabetes while providing a clean and safe tolerability profile.
Daniel Cohen, founder and chief executive officer of Radella, discussed the importance of the results from the clinical trials, saying, "These data validate MD-18 as a next-generation approach to cardiovascular and metabolic health. Participants lost weight and waist circumference and saw improvements in cholesterol and insulin measures. These findings indicate that MD-18 may offer pan-cardiometabolic benefits for common obesity co-morbidities, including heart disease and diabetes."1
MD-18, a first-in-class peptide employs a dual-pronged procedure escalating insulin sensitivity while increasing energy expenditure through reactivation of leptin signaling (often hindered by obesity) through accurate modulation of PTP1B enzymes. Radella believes MD-18 entices the user’s body to burn calories already stored within the body, leading to the desired weight loss results while still maintaining lean muscle mass. This is MD-18’s most notable distinction from other GLP-1 receptor agonists, as other GLP-1s focus on weight reduction through appetite suppression and are commonly linked to decreases in lean muscle mass and tolerability concerns.
The Phase 1b clinical trials, conducted as double-blind placebo-controlling with ascending dosage, registered healthy participants receiving either the placebo or an ascending dosage of MD-18. The trials, spanning four weeks without titration, were held at the Sheba Medical Center in Israel.
Initial results from the trials revealed:
MD-18 aims to reinstitute metabolic signaling by targeting PTP1B modulation, with MD-18 demonstrating in both preclinical models and clinical trials increased insulin sensitivity, lower cholesterol levels, and reductions in alanine aminotransferase. According to the CDC, upwards of two-in-five American adults suffer from obesity; while also being diagnosed with additional chronic conditions such as high blood pressure, heart disease, and diabetes, these additional biomarkers highlight MD-18’s capabilities beyond weight loss.
Following the results of MD-18’s Phase 1b clinical trials, Radella expects to initiate an additional two cohorts into its intent-to-treat population. The additional cohorts will include patients without type 2 diabetes, patients who are overweight, and patients that are overweight and diagnosed with type 2 diabetes. Trials will again administer participants with placebo or a single weekly injection of MD-18 with trials scheduled for 12 weeks.
