On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint Met, Statistical Significance (P<0.025)

在意向治疗分析中，共同主要症状终点符合统计学意义（P<0.025）

Multiple Secondary Symptom Endpoints Met, Statistical Significance (P<0.025)

符合多个次要症状终点，有统计学意义（P<0.025）

On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and Secondary Sign Endpoints Not Met

在意向治疗分析中，未满足共同主要体征终点和次要体征终点

PL9643 Demonstrated Superiority Over Vehicle in Multiple Sign Endpoints

PL9643在多个符号端点上显示出优于车辆的优势

Excellent Safety and Tolerability Profile

良好的安全性和耐受性

Future Discussions Planned with FDA Regarding Regulatory Approval Path

计划与FDA就监管批准途径进行未来讨论

Company to Host Conference Call at 8:30 a.m. ET Today

公司将于美国东部时间今天上午8:30主持电话会议

CRANBURY, N.J., Feb. 28, 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 results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED)..

新泽西州克兰伯里，2024年2月28日/PRNewswire/--Palatin Technologies，Inc.（纽约证券交易所美国代码：PTN），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，今天宣布了其PL9643 MELODY-1关键性3期临床试验的结果，该试验评估了PL9643与赋形剂治疗干眼症（DED）的安全性和有效性。。

MELODY-1 had two co-primary efficacy endpoints: one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining), as well as multiple other symptom and sign secondary endpoints of DED. Duration of treatment was 12 weeks with a 4-week run-in period. Analysis of the data indicated that both age and sex needed to be accounted for in the primary statistical analysis, (60% of the subjects were over age 60; 68% of the subjects were female).

MELODY-1有两个共同的主要疗效终点：一个临床症状（疼痛）和一个临床体征（结膜lissamine green染色），以及DED的多个其他症状和体征次要终点。治疗持续时间为12周，磨合期为4周。数据分析表明，在主要统计分析中需要考虑年龄和性别（60%的受试者年龄超过60岁；68%的受试者为女性）。

After adjusting the Intent-to-Treat (ITT) analysis for age and gender, PL9643 treatment demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints.

在调整了年龄和性别的意向治疗（ITT）分析后，PL9643治疗显示出临床意义（视觉模拟评分比基线降低>10分），并且对于疼痛的共同主要症状终点（p<0.025）和其他多个症状终点具有统计学意义。

PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance. In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance..

PL9643治疗共同主要体征终点和次要体征终点在ITT人群中表现出优于媒介物的积极治疗效果，但没有达到统计学意义。在未经调整的计划分析中，共同主要终点和次要终点没有达到统计学意义。。

'Even with a high vehicle response, PL9643 treatment was clinically meaningful and statistically significantly effective on an ITT basis in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints,' said Carl Spana, Ph.D., President and CEO of Palatin. 'We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign endpoints.'.

Palatin总裁兼首席执行官卡尔·斯潘（CarlSpana）博士说：“即使载体反应很高，PL9643治疗在ITT基础上在减少患者共同原发性疼痛终点和多种其他症状终点的症状方面也具有临床意义和统计学显着效果。”我们很高兴PL9643治疗显示出优异的安全性和耐受性数据，包括与多个标志终点的载体相比具有优异的疗效。”。

'It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom. While additional analyses are ongoing, the initial results reinforce the potential of PL9643 as a treatment to address both symptoms and signs of DED,' continued Dr. Spana. 'Our comprehensive data analysis is ongoing, and upon completion, we plan to meet with the FDA to discuss and get feedback on the design of the next pivotal Phase 3 clinical trial.

“重要的是要注意，在DED中进行的一项临床研究很少显示出对体征和症状的疗效。斯帕纳博士继续说，虽然正在进行其他分析，但初步结果加强了PL9643作为治疗DED症状和体征的潜力我们正在进行全面的数据分析，完成后，我们计划与FDA会面，讨论下一个关键的3期临床试验的设计并获得反馈。

Furthermore, we will continue with our efforts for a collaboration partner for our DED program.'.

此外，我们将继续努力为我们的DED计划寻找合作伙伴。”。

Safety analysis indicated PL9643 was well-tolerated. There were fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287).

安全性分析表明PL9643耐受性良好。与载体（6.3%，N=18/287）相比，PL9643组眼部治疗相关不良事件较少（5.6%，N=16/288），PL9643组研究中断较少（7.0%，N=20/288）与载体（11.1%，N=32/287）相比。

PL9643 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment that also has an excellent safety and tolerability profile.1.

PL9643代表了缓解干眼症患者的机会。虽然DED是最常见的眼部疾病之一，估计在美国有3800万人受到影响，但只有约1800万人被诊断出，只有不到10%的被诊断出患有处方药。这表明对有效治疗的显着未满足的医疗需求也具有优异的安全性和耐受性。

The data from the pivotal Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints, after treatment for 12 weeks.

关键的3期MELODY-1试验的数据是一项多中心，随机，双盲和媒介物对照研究，在美国招募了575名患者。该试验评估了黑皮质素激动剂PL9643眼用溶液与媒介物在中度至重度DED患者中的多个体征和症状终点的安全性和有效性，治疗12周后。

The study design was based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-Phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program..

该研究设计基于PL9643治疗DED的第二阶段阳性结果，以及与FDA就关键的第三阶段临床计划的关键要素举行的第二阶段会议结束。。

Conference Call / Webcast

电话会议/网络广播

Palatin will host a conference call and audio webcast on February 28, 2024, at 8:30 a.m. Eastern Time to discuss the PL9643 Phase 3 clinical study results in greater detail. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 295124. The audio webcast and replay can be accessed by logging on to the 'Investor-Webcasts' section of Palatin's website at http://www.palatin.com or by clicking here.

Palatin将于2024年2月28日东部时间上午8:30主持电话会议和音频网络广播，以更详细地讨论PL9643 3期临床研究结果。有兴趣收听电话会议直播的个人可以拨打1-888-506-0062（美国）或1-973-528-0011（国际），参与者访问代码：295124。可以通过登录Palatin网站的“投资者网络广播”部分访问音频网络广播和重播http://www.palatin.com或者单击此处。

A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 50021. The webcast and telephone replay will be available through March 13, 2024..

通话结束后一小时将提供电话和音频网络广播重播。要访问电话重播，请拨打1-877-481-4010（美国）或1-919-882-2331（国际），重播密码50021。网络广播和电话重播将持续到2024年3月13日。。

About Dry Eye Disease (DED)

关于干眼病（DED）

Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment.

干眼症是一种常见的炎症性疾病，如果不及时治疗，可能会变得非常痛苦，并导致角膜和视力的永久性损伤。DED影响眼睛的角膜和结膜，导致刺激，发红，疼痛和视力模糊。该疾病的特征是眼睛前表面水分和润滑不足，导致干燥，炎症，疼痛，不适，刺激，生活质量下降，严重时会导致永久性视力障碍。

Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity..

许多医生和患者通常认为现有的DED治疗方法不足，通常需要数周或数月才能证明其活动。。

References

参考文献

1.  Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.

1、市场范围2023年干眼症产品市场回顾；不包括OTC人工泪液和其他Rx抗炎和催泪兴奋剂。

About Melanocortin Receptor Agonists and Inflammation

关于黑皮质素受体激动剂和炎症

The melanocortin receptor ('MCr') system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MCR1 through MCR5. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

黑皮质素受体（“MCr”）系统对炎症，免疫系统反应，新陈代谢，食物摄入和性功能有影响。有五种黑皮质素受体，MCR1到MCR5。通过使用激活受体功能的受体特异性激动剂或阻断受体功能的受体特异性拮抗剂来调节这些受体，可以具有医学上显着的药理作用。

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation..

位于眼睛（以及其他地方，例如肠道和肾脏）的许多组织和免疫细胞表达黑皮质素受体，使我们有机会直接激活自然途径来解决疾病炎症。。

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, including PL9643, 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. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby.

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，例如关于正在开发的Palatin产品的声明，包括PL9643、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、候选产品的建议适应症，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节以及1995年《私人证券诉讼改革法》中定义的“前瞻性声明”。Palatin打算此类前瞻性声明应遵守由此产生的安全港。

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'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 is not re.

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资助其技术开发以及建立和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，帕拉丁产品的商业接受程度，以及帕拉丁定期向证券交易委员会提交文件中讨论的其他因素。Palatin不是re。

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

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

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SOURCE Palatin Technologies, Inc.

来源：Palatin Technologies，Inc。

Company Codes: AMEX:PTN

公司代码：美国运通：PTN