Phase 2 clinical study expected to begin in mid-calendar year 2024

第二阶段临床研究预计于2024年中开始

Topline data expected by calendar year-end 2024

2024年日历年末的预期顶线数据

Hosting virtual KOL event 'Beyond GLPs' on May 8, 2024

2024年5月8日举办虚拟KOL活动“超越GLPs”

Focus will be on Company's metabolic program and the multiple roles for novel melanocortin receptor 4 agonists in treating obesity and weight loss maintenance

重点将放在公司的代谢计划以及新型黑皮质素受体4激动剂在治疗肥胖和减肥维持中的多重作用

CRANBURY, N.J., May 2, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the treatment of obesity.

新泽西州克兰伯里（CRANBURY），2024年5月2日/PRNewswire/-Palatin Technologies，Inc.（纽约证券交易所美国代码：PTN），一家开发基于调节黑皮质素受体系统活性分子的一流药物的生物制药公司，今天宣布，美国食品和药物管理局（FDA）已经完成了对使用黑皮质素受体4激动剂（MCR4）bremelanotide治疗肥胖症的研究性新药（IND）申请的30天审查。

The Company is cleared to begin enrollment in a Phase 2 clinical study evaluating the safety and efficacy of bremelanotide, co-administered with tirzepatide (GLP1/GIP) in obese patients. The Phase 2 clinical study is expected to start mid-calendar year 2024, with topline data results by the end of calendar year 2024..

该公司已获准开始参加一项2期临床研究，该研究评估了bremelanotide的安全性和有效性，该药物与替罗西肽（GLP1/GIP）联合用于肥胖患者。第二阶段临床研究预计将于2024年中开始，到2024年年底将有最终数据结果。。

Phase 2 Trial Design

第二阶段试验设计

The clinical study, 'A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity' has been reviewed by FDA with an approval to proceed under Palatin's IND.

这项临床研究“一项II期，随机，双盲，安慰剂对照的临床研究，研究了布雷黑肽与Tirzepatide（GLP-1/GIP）联合治疗肥胖的安全性，耐受性和有效性”，已由FDA审查，并批准根据Palatin的IND进行。

The study is designed to enroll up to 60 patients actively on tirzepatide at approximately five trial sites in the U.S. The primary endpoint of the trial is to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight. Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens.

这项研究的目的是在美国大约五个试验地点招募多达60名积极服用tirzepatide的患者。该试验的主要终点是证明bremelanotide与tirzepatide联合给药对减轻体重的安全性和有效性。患者将仅接受tirzepatide治疗四周，确认合格，然后随机分为四种治疗方案之一。

Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1/GIP therapy..

患者将接受多项安全性和有效性评估，以帮助描述bremelanotide作为独立治疗或与GLP-1/GIP治疗联合治疗一般肥胖的有效性。。

'Therapeutic options for obesity treatment requires multiple pathways to safely, effectively, and consistently treat and maintain weight loss. MCR4 agonism is a well validated mechanism for weight loss. Our research and emerging clinical data indicate that combining an MCR4 agonist with incretin therapeutics like tirzepatide may result in synergistic effects on weight loss allowing for increased weight loss at lower and better tolerated doses,' said Carl Spana, Ph.D., President and CEO of Palatin.

“肥胖治疗的治疗选择需要多种途径来安全，有效，一致地治疗和维持体重减轻。MCR4激动剂是一种经过充分验证的减肥机制。Palatin总裁兼首席执行官卡尔·斯潘（CarlSpana）博士说：“我们的研究和新出现的临床数据表明，将MCR4激动剂与肠降血糖素治疗剂（如替罗巴肽）联合使用可能会对减肥产生协同作用，从而在较低和更好的耐受剂量下增加减肥效果。”。

'We have extensive experience in obesity research, a portfolio of novel selective MCR4 agonists, and ready access to bremelanotide, an FDA approved MCR4 agonist. We are excited by the FDA's acceptance of our IND to further study the utility of melanocortin agonists as a potential treatment option for obesity.'.

“我们在肥胖研究，新型选择性MCR4激动剂组合以及FDA批准的MCR4激动剂bremelanotide方面拥有丰富的经验。FDA接受我们的IND，进一步研究黑皮质素激动剂作为肥胖潜在治疗选择的效用，我们对此感到兴奋。”。

Virtual KOL Event

虚拟KOL事件

The event will focus on the Company's metabolic program evaluating novel selective melanocortin receptor 4 agonists (MCR4) as effective and safe treatment for obesity and weight loss maintenance. The KOL event features Jesse Richards, DO (Oklahoma State University College of Osteopathic Medicine), who will discuss the current treatment landscape for obesity, including the use of incretin therapeutics as the standard of care, and the unmet need for new treatments with alternative mechanisms of action, and how combining a melanocortin agonist with incretins, like GLP-1s, can optimize treatment..

该活动将重点关注该公司的代谢计划，评估新型选择性黑皮质素受体4激动剂（MCR4）作为肥胖和减肥维持的有效且安全的治疗方法。KOL活动的特点是Jesse Richards，DO（俄克拉荷马州立大学骨科医学院），他将讨论目前肥胖的治疗前景，包括使用肠促胰岛素治疗作为护理标准，以及对替代作用机制的新治疗的未满足需求，以及如何将黑皮质素激动剂与肠促胰岛素（如GLP-1s）结合使用可以优化治疗。。

The virtual KOL event will take place at 10:00 AM Eastern Time on May 8th. A live question and answer session will follow the formal presentations. To register for the event, please click here.

虚拟KOL活动将于5月8日东部时间上午10:00举行。正式演讲后将进行现场问答环节。要注册活动，请单击此处。

Palatin has significant experience and an extensive intellectual property portfolio in the design and development of MCR4 agonists that can be used as treatments for obesity. This includes novel selective MCR4 peptide agonists and oral small molecule MCR4 agonists.

Palatin在设计和开发可用于治疗肥胖症的MCR4激动剂方面拥有丰富的经验和广泛的知识产权组合。这包括新型选择性MCR4肽激动剂和口服小分子MCR4激动剂。

Palatin previously announced a poster presentation of preclinical data, entitled Melanocortin receptor 4 agonist PL8905 in Combination with Glucagon Like Peptide-1 Produces Synergistic Weight Loss, Reduced Food Intake, and Greater Glucose Control in Diet-Induced Obese (DIO) Rats (Dodd et al.) at the Peptide Therapeutics Symposium, October 16-17, 2023 in La Jolla, CA..

Palatin之前在2023年10月16日至17日于加利福尼亚州拉霍亚举行的肽治疗研讨会上宣布了一份临床前数据海报，题为黑皮质素受体4激动剂PL8905与胰高血糖素样肽-1联合使用，可在饮食诱导的肥胖（DIO）大鼠中产生协同减肥，减少食物摄入和更好的葡萄糖控制（Dodd等人）。。

GLP-1 agonists are currently the standard of care treatment for obesity. However, real-world use data shows that more than two-thirds (68%) of obese patients discontinue use in the first year. Side effects, especially at higher dose levels and a plateau effect, contribute to the high discontinuation rate.

GLP-1激动剂目前是肥胖的标准治疗方法。然而，实际使用数据显示，超过三分之二（68%）的肥胖患者在第一年停止使用。副作用，特别是在较高剂量水平和平台效应下，导致高停药率。

Palatin's innovative approach aims to address these issues by improving treatment adherence and promoting consistent long term weight loss through combination therapy. By co-administering an MCR4 agonist with a GLP-1 agonist, Palatin anticipates achieving significant weight loss at lower doses, with improved tolerability.

Palatin的创新方法旨在通过改善治疗依从性和通过联合治疗促进持续的长期减肥来解决这些问题。通过将MCR4激动剂与GLP-1激动剂共同给药，Palatin预期在较低剂量下实现显着的体重减轻，并具有改善的耐受性。

Combination drug therapy will be a key part of improving the overall health and quality of life for obese patients..

联合药物治疗将是改善肥胖患者整体健康和生活质量的关键部分。。

The use of combination therapy is supported by preclinical data with MCR4 agonist PL8905 and two previous clinical studies with MCR4 agonist bremelanotide demonstrating statistically significant effects on reducing food intake and weight loss in obese patients (published data; Spana C, Jordan R, Fischkoff S.

联合治疗的使用得到了MCR4激动剂PL8905的临床前数据和之前两项MCR4激动剂bremelanotide的临床研究的支持，这两项临床研究表明，在减少肥胖患者的食物摄入和体重减轻方面具有统计学意义（已发表的数据；Spana C，Jordan R，Fischkoff S。

Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes Obes Metab. 2022;1-10. doi:10.1111/dom.14672 is available at www.Palatin.com)..

bremelanotide对肥胖女性体重的影响：来自两项1期随机对照试验的数据。糖尿病Obes代谢。2022年；1-10。doi:10.1111/dom.14672可从www.Palatin.com获得）。。

About Melanocortin Receptor 4 Agonists Effect on Obesity

关于黑皮质素受体4激动剂对肥胖的影响

Genetic analysis has identified the melanocortin receptor 4 (MCR4) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MCR4 pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders.

遗传分析已经确定下丘脑室旁核的黑皮质素受体4（MCR4）在食欲调节中起着核心作用。抑制MCR4途径信号传导的基因突变导致食欲亢进，能量消耗减少和早发性肥胖；这种突变已被确定为几种罕见的遗传性肥胖疾病的原因。

Agouti-related peptide is an endogenous antagonist of the MCR4 that works with neuropeptide Y to stimulate appetite, whereas MCR4 agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MCR4 therefore represents an attractive target for potential obesity treatments..

刺豚鼠相关肽是MCR4的内源性拮抗剂，与神经肽Y一起刺激食欲，而MCR4激动剂如α-和β-黑素细胞刺激素促进饱腹感。因此，MCR4的激动作用代表了潜在肥胖治疗的有吸引力的目标。。

About Obesity

关于肥胖

Obesity, which is defined as a body mass index (BMI) ≥30 kg/m2, represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers.

肥胖被定义为体重指数（BMI）≥30 kg/m2，代表着全球公共卫生问题的日益严重。肥胖会增加总体死亡风险和严重健康状况，包括高血压、高胆固醇、2型糖尿病、冠心病、中风和某些癌症。

Health-related quality of life is significantly lower among adults with obesity, and obesity is associated with increased health care resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.

肥胖成年人的健康相关生活质量显着降低，肥胖与医疗保健资源使用增加和经济负担高有关。因此，安全有效的肥胖治疗仍然是一个关键的未满足需求。肥胖患病率的全球增加是一个公共卫生问题，对医疗保健系统具有严重的成本影响。

In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity..

在美国，大约42%的成年人患有肥胖症，12-19岁的青少年中有五分之一患有肥胖症。。

About Palatin

关于Palatin

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential.

Palatin是一家生物制药公司，开发基于调节黑皮质素受体系统活性的分子的一流药物，具有靶向的受体特异性候选产品，用于治疗具有显着未满足的医疗需求和商业潜力的疾病。

Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on www.Palatin.com and follow us on Twitter at @PalatinTech..

Palatin的战略是开发产品，然后与行业领导者形成营销合作，以最大限度地发挥其商业潜力。要了解更多关于Palatin的信息，请访问www.Palatin.com，并在推特上关注我们@PalatinTech。。

Forward-looking Statements

前瞻性声明

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995.

本新闻稿中非历史事实的声明，包括关于Palatin Technologies，Inc.未来预期的声明，如关于Palatin产品开发中的声明、临床试验结果、包括FDA在内的监管机构的潜在行动、监管计划、开发计划、候选产品的拟议适应症以及候选产品的市场潜力，是1933年《证券法》第27A节、1934年《证券交易法》第21E节含义内的“前瞻性声明”，该术语在1995年《私人证券诉讼改革法》中有定义。

Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements.

Palatin希望此类前瞻性声明受到由此产生的安全港的约束。此类前瞻性声明涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致Palatin的实际结果与其历史结果或此类前瞻性声明明示或暗示的任何结果存在重大差异。

Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission.

Palatin的实际结果可能与前瞻性声明中讨论的结果存在重大差异，原因包括但不限于临床试验结果、FDA和其他监管机构的监管行动以及监管批准的需要、Palatin资助其技术开发和建立并成功完成临床试验的能力、完成临床试验和提交监管批准申请所需的时间和成本、竞争性制药、生物制药和生物技术公司开发的产品、Palatin产品的商业接受程度以及Palatin定期向证券交易委员会提交文件中讨论的其他因素。

Palatin is not responsible for upda.

Palatin不负责upda。

Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.

Palatin Technologies®是Palatin Technologies，Inc.的注册商标。

View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-announces-fda-clearance-of-ind-application-for-the-co-administration-of-bremelanotide-with-tirzepatide-glp-1-for-the-treatment-of-obesity-302134204.html

查看原始内容以下载多媒体：https://www.prnewswire.com/news-releases/palatin-announces-fda-clearance-of-ind-application-for-the-co-administration-of-bremelanotide-with-tirzepatide-glp-1-for-the-treatment-of-obesity-302134204.html

SOURCE Palatin Technologies, Inc.

来源：Palatin Technologies，Inc。

Company Codes: AMEX:PTN

公司代码：美国运通：PTN