NEW YORK--(BUSINESS WIRE)--Radella Pharmaceuticals, LLC., a clinical-stage biopharmaceutical company developing innovative therapies for cardiometabolic disorders, today announced topline results from the Phase 1a MD-18 clinical study evaluating the safety, tolerability, and pharmacokinetics of its investigational MD-18 program for the treatment of obesity and diabetes. MD-18 represents a breakthrough in targeting protein-tyrosine phosphatase 1B (PTP1B), a therapeutic target that has been shown to play a major role in glucose homeostasis and energy metabolism. Radella has identified a family of novel peptides targeting PTP1B through the disruption of a highly-specific, non-allosteric interaction with a second regulatory protein. This approach avoids the off-target effects that have been associated with inhibitors of PTP1B.
The Phase 1a study, a single center, single dose, randomized, double-blind, placebo-controlled trial, enrolled 35 healthy subjects who received a single subcutaneous dose of MD-18 ranging from 40mg to 320mg. MD-18 was shown to be safe and well-tolerated across all dose levels, with no serious adverse events or discontinuations. The only treatment-related effects were mild, transient injection site reactions, establishing a favorable safety profile in humans. Notably, subjects receiving MD-18 showed consistent improvements across a number of metabolic parameters after 7 days, including reductions in leptin levels, improved insulin sensitivity, and decreases in alanine aminotransferase (ALT), LDL-cholesterol, and total cholesterol, all of which were not observed in patients on placebo. Patients receiving MD-18 also reported reductions in appetite.
“These findings after just a single dose highlight the potential of MD-18 to deliver clinically meaningful metabolic benefits,” said Amir Tirosh, MD, PhD, Chief Medical Officer of Radella and Director, Division of Endocrinology, Diabetes and Metabolism at Sheba Medical Center and Professor of Medicine at Tel-Aviv University School of Medicine. “MD-18’s unique mechanism of action targets both insulin sensitivity and energy expenditure through PTP1B regulation and the leptin pathway, representing a potentially transformative approach for patients with obesity and metabolic disease.”
MD-18’s novel approach disrupts a protein-protein interaction (PPI) to regulate PTP1B, a well-validated therapeutic target. Extensive preclinical studies in disease-relevant models have demonstrated that modulation of PTP1B by MD-18 leads to significant improvements in insulin sensitivity and a significant loss of weight and adiposity with preservation of lean muscle mass – crucial differentiators from existing treatments.
“Current obesity treatments primarily focus on appetite suppression without addressing the underlying causes of metabolic dysfunction,” said Daniel Cohen, Founder, Chairman, and Chief Executive Officer of Radella. “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 program to evaluate MD-18’s full therapeutic potential.”
Radella plans to initiate a Phase 1b study before the end of the year to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous doses of MD-18 in up to 72 subjects, including overweight volunteers without other health conditions as well as patients with obesity or type 2 diabetes. Cohorts will assess both dose and dose frequency over 4 weeks, with an 8-week extension for the obese and diabetic cohorts.
For more information on the MD-18 clinical program, please visit: radellapharma.com.
About Radella Pharmaceuticals
Radella Pharmaceuticals, LLC., headquartered in New York, NY, with operations in Aberdeen, SCO and Tel Aviv, ISR, is a privately-backed, clinical-stage biopharmaceutical company developing transformative therapies in cardiometabolic disease and beyond. Singularly focused on delivering curative solutions to patients and bettering human health, the company has successfully advanced its lead asset, MD-18, into clinical trials, developing a pipeline of follow-on assets targeting unmet needs in other large therapeutic areas, including neurodegenerative and fatty liver disease. MD-18 is a first-in-class peptide that targets multiple pathways involved in obesity and related metabolic conditions. MD-18 demonstrates a breakthrough in targeting protein-tyrosine phosphatase 1B (PTP1B), a historically challenging therapeutic target that plays a crucial role in metabolic regulation. MD-18’s unique mechanism of action, which targets both insulin sensitivity and energy expenditure through PTP1B regulation and the leptin pathway, represents a potentially transformative approach for patients with cardiometabolic disease and its adjacencies. For more information on Radella’s clinical program and current trials, visit radellapharma.com.
