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.

纽约--（商业新闻短讯）--Radella Pharmaceuticals，LLC.，一家开发心脏代谢紊乱创新疗法的临床阶段生物制药公司，今天宣布了1a期MD-18临床研究的主要结果，该研究评估了其用于治疗肥胖和糖尿病的研究性MD-18计划的安全性，耐受性和药代动力学。

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.

MD-18代表了靶向蛋白酪氨酸磷酸酶1B（PTP1B）的突破，PTP1B是一种治疗靶点，已被证明在葡萄糖稳态和能量代谢中起主要作用。Radella通过破坏与第二种调节蛋白的高度特异性非变构相互作用，鉴定了一系列靶向PTP1B的新型肽。

This approach avoids the off-target effects that have been associated with inhibitors of PTP1B..

这种方法避免了与PTP1B抑制剂相关的脱靶效应。。

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.

1a期研究是一项单中心，单剂量，随机，双盲，安慰剂对照试验，招募了35名健康受试者，他们接受单次皮下剂量的MD-18，范围从40mg到320mg。MD-18被证明在所有剂量水平上都是安全且耐受性良好的，没有严重的不良事件或停药。

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.

唯一与治疗相关的影响是轻微的短暂注射部位反应，在人体内建立了良好的安全性。。

Patients receiving MD-18 also reported reductions in appetite..

接受MD-18治疗的患者也报告食欲下降。。

“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.

Radella首席医学官、Sheba医学中心内分泌、糖尿病和代谢科主任、特拉维夫大学医学院医学教授阿米尔·蒂罗什（AmirTirosh）医学博士说：“单次给药后的这些发现突显了MD-18具有临床意义的代谢益处的潜力。”。

“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独特的作用机制通过PTP1B调节和瘦素途径靶向胰岛素敏感性和能量消耗，代表了肥胖和代谢疾病患者潜在的变革方法。”。

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..

MD-18的新方法破坏了蛋白质-蛋白质相互作用（PPI）以调节PTP1B，这是一种经过充分验证的治疗靶标。在疾病相关模型中进行的广泛临床前研究表明，MD-18对PTP1B的调节可显着改善胰岛素敏感性，并显着减轻体重和肥胖，同时保留瘦肌肉量，这是与现有治疗方法的关键区别。。

“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.

Radella创始人、董事长兼首席执行官丹尼尔·科恩（DanielCohen）表示：“目前的肥胖治疗主要集中在抑制食欲，而没有解决代谢功能障碍的根本原因。”。“MD-18的分化机制有望改善胰岛素敏感性和其他关键代谢途径，可能为患者提供新的治疗选择，无论是作为独立治疗还是与现有治疗相结合。

Based on these encouraging Phase 1a results, we look forward to advancing our clinical program to evaluate MD-18’s full therapeutic potential.”.

基于这些令人鼓舞的1a期结果，我们期待着推进我们的临床计划，以评估MD-18的全部治疗潜力。”。

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.

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Cohorts will assess both dose and dose frequency over 4 weeks, with an 8-week extension for the obese and diabetic cohorts..

队列将在4周内评估剂量和剂量频率，肥胖和糖尿病队列延长8周。。

For more information on the MD-18 clinical program, please visit: radellapharma.com.

有关MD-18临床计划的更多信息，请访问：radellapharma.com。

About Radella Pharmaceuticals

关于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.

Radella Pharmaceuticals，LLC，总部位于纽约州纽约市，在阿伯丁，SCO和特拉维夫，ISR运营，是一家私人支持的临床阶段生物制药公司，开发心脏代谢疾病及其他疾病的转化疗法。该公司专注于为患者提供治愈性解决方案和改善人类健康，已成功将其领先资产MD-18推进临床试验，开发了一系列后续资产，以满足其他大型治疗领域的需求，包括神经退行性疾病和脂肪肝疾病。

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是一种一流的肽，其靶向涉及肥胖和相关代谢状况的多种途径。MD-18在靶向蛋白酪氨酸磷酸酶1B（PTP1B）方面取得了突破，PTP1B是一种具有历史挑战性的治疗靶点，在代谢调节中起着至关重要的作用。

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..

MD-18独特的作用机制通过PTP1B调节和瘦素途径靶向胰岛素敏感性和能量消耗，代表了心脏代谢疾病及其邻近患者的潜在变革方法。有关Radella临床项目和当前试验的更多信息，请访问radellapharma.com。。