Radella Pharmaceuticals Reports Phase 1a Results of MD-18 for Obesity

Radella Pharmaceuticals, LLC, headquartered in New York, has announced promising results from its Phase 1a MD-18 clinical study, which focuses on evaluating the safety, tolerability, and pharmacokinetics of its investigational MD-18 program designed to treat obesity and diabetes. MD-18 is a novel therapeutic approach targeting protein-tyrosine phosphatase 1B (PTP1B), a crucial factor in managing glucose levels and energy metabolism. Radella has developed a unique family of peptides that target PTP1B by disrupting a specific, non-allosteric interaction with another regulatory protein, thereby avoiding the off-target effects common with other PTP1B inhibitors.

The Phase 1a clinical trial was a single-center, single-dose, randomized, double-blind, placebo-controlled study. It involved 35 healthy participants who received varying single subcutaneous doses of MD-18, ranging from 40mg to 320mg. The outcomes revealed that MD-18 was safe and well-tolerated at all dose levels, with no serious adverse effects or discontinuations. Only mild, temporary injection site reactions were observed, establishing a favorable safety profile. After 7 days, significant metabolic improvements were noted in subjects receiving MD-18: reduced leptin levels, better insulin sensitivity, and decreased levels of alanine aminotransferase (ALT), LDL-cholesterol, and total cholesterol, which were not present in the placebo group. Additionally, there was a reported reduction in appetite among those receiving MD-18.

Dr. Amir Tirosh, Radella's Chief Medical Officer, highlighted the potential of MD-18, noting its ability to offer significant metabolic benefits from just one dose. MD-18 employs a unique mechanism targeting both insulin sensitivity and energy expenditure through PTP1B regulation and the leptin pathway, presenting a transformative approach for those with obesity and metabolic diseases.

MD-18's innovative method involves disrupting a protein-protein interaction to regulate PTP1B, a validated therapeutic target. Extensive preclinical studies have shown that modulating PTP1B with MD-18 leads to significant improvements in insulin sensitivity, weight loss, and reduced adiposity, while preserving lean muscle mass, distinguishing it from current treatments.

Daniel Cohen, founder and CEO of Radella, emphasized that current obesity treatments mainly focus on suppressing appetite without addressing the root causes of metabolic dysfunction. He pointed out that MD-18's unique mechanism demonstrates potential in improving insulin sensitivity and other critical metabolic pathways, offering a new therapeutic option either as a standalone treatment or in combination with existing therapies. Following the encouraging Phase 1a results, Radella aims to advance its clinical program to fully explore MD-18's therapeutic potential.

Radella plans to commence a Phase 1b study before the year's end. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous doses of MD-18 in up to 72 subjects, including those who are overweight without other health conditions as well as patients with obesity or type 2 diabetes. These cohorts will examine both the dose and frequency over four weeks, with an eight-week extension for the obese and diabetic groups.

Radella Pharmaceuticals, based in New York, with additional operations in Aberdeen and Tel Aviv, is a clinical-stage biopharmaceutical company focused on developing revolutionary therapies for cardiometabolic diseases and other significant therapeutic areas, including neurodegenerative and fatty liver diseases. Their lead asset, MD-18, is a first-in-class peptide targeting multiple pathways involved in obesity and related metabolic conditions, marking a significant advancement in targeting PTP1B.