<p><em><strong>研究结果支持进入第二阶段，以探索针对压力相关神经精神疾病的首创途径</strong></em></p>
<p>Protagenic Therapeutics Inc.（纳斯达克代码：PTIX）是一家开发针对慢性压力生物学及其下游精神和神经影响的生物制药公司，今天报告了其 PT00114 的第一阶段多剂量（MD）研究的积极安全性结果。</p>
<p>PT00114 是一种合成类脑肽的类似物，认为它参与在长期暴露于压力后恢复体内平衡。其作用机制根植于重新平衡功能失调的压力反应电路，代表了一种不同于传统神经递质聚焦方法的途径，可能为那些现有疗法治疗不足的患者提供新的解决方案。</p>
<p><strong>第一阶段 MD 研究概述</strong></p>
<p>该研究在健康志愿者中进行，旨在评估 PT00114 在多个剂量水平上的安全性、耐受性和药代动力学特征。所有计划的队列均已完成给药。</p>
<p>初步分析显示：</p>
<ul>
<li>PT00114 在所有研究的剂量范围内耐受良好。</li>
<li>报告的不良事件与基于肽的注射疗法的预期一致，包括预期的注射部位反应。</li>
<li>未观察到严重不良事件，所有参与者均完成了指定的给药计划。</li>
</ul>
<p>&#34;这些结果为推进 PT00114 提供了明确的安全基础，&#34;Protagenic Therapeutics 的执行董事长 Garo Armen 博士表示。&#34;第一阶段研究达到了其设计目标——建立耐受性并描述该化合物在人体中的行为。此外，几位接受 PT00114 的参与者报告了改善的幸福感，这一发现虽然在此阶段是轶事性的，但与该化合物的预期生物活性一致。&#34;</p>
<p>Armen 博士补充道：&#34;在压力相关的精神疾病中，存在显著的未满足需求，许多患者在多种疗法之间循环而未能获得足够的缓解。PT00114 的上游机制——调节压力轴而不仅仅是神经递质释放——提供了一种根本不同的方法。第一阶段的安全性特征使我们有信心继续推进。&#34;</p>
<p><strong>下一步</strong></p>
<p>Protagenic Therapeutics 正在最终确定对完整第一阶段数据集的详细分析，包括药代动力学建模以支持剂量选择。一旦分析完成，将发布综合报告。</p>
<p>该公司预计将在 2026 年初启动第二阶段研究，以评估 PT00114 在受慢性压力相关精神疾病影响的目标患者群体中的效果。关于研究设计和终点的更多细节将在未来几个月内公布。</p>
<p><strong>关于 Protagenic Therapeutics, Inc.</strong></p>
<p>Protagenic Therapeutics, Inc.（纳斯达克代码：PTIX）是一家专注于开发创新的基于肽的疗法，针对压力相关的神经和情绪障碍的生物途径。该公司的主要化合物 PT00114 是一种合成类自然脑肽的类似物，有助于调节身体的压力反应和情绪平衡。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿中的声明包含美国联邦证券法意义上的&#34;前瞻性声明&#34;。前瞻性声明可以通过诸如&#34;项目&#34;、&#34;可能&#34;、&#34;将&#34;、&#34;可以&#34;、&#34;会&#34;、&#34;应该&#34;、&#34;相信&#34;、&#34;期望&#34;、&#34;预期&#34;、&#34;估计&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;潜在&#34;、&#34;承诺&#34;或类似的未来时期的参考词来识别。本报告中的前瞻性声明的示例包括但不限于关于公司预计提交其 10-Q 季度报告的声明、公司计划在小组面前提出上诉的声明，以及公司证券在上诉期间的持续上市。前瞻性声明不是历史事实或未来表现的保证。相反，它们基于公司对其业务未来、未来计划、战略、预测、预期事件和趋势、经济及其他未来条件的当前信念、期望和假设。由于前瞻性声明涉及未来，因此它们受到固有风险和不确定性的影响，实际结果可能与前瞻性声明中所述的结果有重大差异。可能导致实际结果不同的重要因素包括但不限于，无法保证公司将提交 10-Q 表格，无法保证公司将满足纳斯达克合规标准，无法保证纳斯达克将给予公司任何必要的退市救济，或公司是否能够同意或最终满足任何此类救济的适用纳斯达克要求，以及在公司向 SEC 提交的文件中描述的其他重要因素。公司在本报告中所做的任何前瞻性声明仅基于当前可用的信息，并仅在声明之日有效。除非适用法律要求，否则公司明确不承担公开更新任何前瞻性声明的义务，无论是书面还是口头，可能会不时做出，无论是由于新信息、未来发展还是其他原因。</p>
<p><strong>公司联系方式：</strong></p>
<p>Alexander K. Arrow, MD, CFA</p>
<p>首席财务官</p>
<p>Protagenic Therapeutics, Inc.</p>
<p>149 Fifth Ave, Suite 500, New York, NY 10010</p>
<p>电话：213-260-4342</p>
<p>电子邮件：alex.arrow@protagenic.com</p>
<p><strong>来源：</strong> Protagenic Therapeutics, Inc.</p>
<p>查看原始新闻稿，请访问 ACCESS Newswire</p>
<p><img src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTExNTc4OA?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTExNTc4OA"/></p>

PTIX

<p>Protagenic Therapeutics Inc. 报告了其 PT00114 的 I 期研究的积极安全结果，该合成脑肽旨在治疗与压力相关的神经精神疾病。研究显示 PT00114 耐受性良好，没有严重不良事件。该公司计划在 2026 年推进至 II 期，以进一步探索其治疗潜力。PT00114 通过调节压力反应电路提供了一种新方法，而不仅仅是专注于神经递质的释放</p>

<p><em><strong>Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions</strong></em></p>
<div class="lb-trans"><p><em><strong>研究结果支持进入第二阶段，以探索针对压力相关神经精神疾病的首创途径</strong></em></p>
</div><p>Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its Phase 1 Multiple Dose (MD) study of PT00114.</p>
<div class="lb-trans"><p>Protagenic Therapeutics Inc.（纳斯达克代码：PTIX）是一家开发针对慢性压力生物学及其下游精神和神经影响的生物制药公司，今天报告了其 PT00114 的第一阶段多剂量（MD）研究的积极安全性结果。</p>
</div><p>PT00114 is a synthetic analogue of a naturally occurring brain peptide thought to be involved in restoring homeostasis following prolonged exposure to stress. Its mechanism of action-rooted in rebalancing dysfunctional stress-response circuits-represents a departure from conventional neurotransmitter-focused approaches and may offer a new pathway for patients whose conditions remain insufficiently treated with existing therapies.</p>
<div class="lb-trans"><p>PT00114 是一种合成类脑肽的类似物，认为它参与在长期暴露于压力后恢复体内平衡。其作用机制根植于重新平衡功能失调的压力反应电路，代表了一种不同于传统神经递质聚焦方法的途径，可能为那些现有疗法治疗不足的患者提供新的解决方案。</p>
</div><p><strong>Phase 1 MD Study Overview</strong></p>
<div class="lb-trans"><p><strong>第一阶段 MD 研究概述</strong></p>
</div><p>The study was conducted in healthy volunteers and was designed to evaluate the safety, tolerability, and pharmacokinetic profile of PT00114 across multiple dose levels. All planned cohorts have completed dosing.</p>
<div class="lb-trans"><p>该研究在健康志愿者中进行，旨在评估 PT00114 在多个剂量水平上的安全性、耐受性和药代动力学特征。所有计划的队列均已完成给药。</p>
</div><p>Preliminary analyses show:</p>
<div class="lb-trans"><p>初步分析显示：</p>
</div><ul>
<li>PT00114 was well tolerated across all dose ranges studied.</li>
<li>Reported adverse events were consistent with expectations for a peptide-based injectable therapy, including expected injection-site reactions.</li>
<li>No serious adverse events were observed, and all participants completed the assigned dosing schedules.</li>
</ul>
<div class="lb-trans"><ul>
<li>PT00114 在所有研究的剂量范围内耐受良好。</li>
<li>报告的不良事件与基于肽的注射疗法的预期一致，包括预期的注射部位反应。</li>
<li>未观察到严重不良事件，所有参与者均完成了指定的给药计划。</li>
</ul>
</div><p>&#34;These results provide a clear safety foundation for advancing PT00114,&#34; said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics. &#34;The Phase 1 study achieved what it was designed to do-establish tolerability and characterize the compound's behavior in humans. In addition, several participants who received PT00114 reported an improved sense of well-being, a finding that, while anecdotal at this stage, aligns with the compound's intended biological activity.&#34;</p>
<div class="lb-trans"><p>&#34;这些结果为推进 PT00114 提供了明确的安全基础，&#34;Protagenic Therapeutics 的执行董事长 Garo Armen 博士表示。&#34;第一阶段研究达到了其设计目标——建立耐受性并描述该化合物在人体中的行为。此外，几位接受 PT00114 的参与者报告了改善的幸福感，这一发现虽然在此阶段是轶事性的，但与该化合物的预期生物活性一致。&#34;</p>
</div><p>Dr. Armen added, &#34;There is significant unmet need in stress-related psychiatric conditions, where many patients cycle through multiple therapies without adequate relief. PT00114's upstream mechanism-modulating the stress axis rather than solely neurotransmitter release-offers a fundamentally different approach. The safety profile emerging from Phase 1 gives us confidence to proceed.&#34;</p>
<div class="lb-trans"><p>Armen 博士补充道：&#34;在压力相关的精神疾病中，存在显著的未满足需求，许多患者在多种疗法之间循环而未能获得足够的缓解。PT00114 的上游机制——调节压力轴而不仅仅是神经递质释放——提供了一种根本不同的方法。第一阶段的安全性特征使我们有信心继续推进。&#34;</p>
</div><p><strong>Next Steps</strong></p>
<div class="lb-trans"><p><strong>下一步</strong></p>
</div><p>Protagenic Therapeutics is finalizing its detailed analysis of the full Phase 1 dataset, including pharmacokinetic modeling to support dose selection. A comprehensive report will be released once analyses are complete.</p>
<div class="lb-trans"><p>Protagenic Therapeutics 正在最终确定对完整第一阶段数据集的详细分析，包括药代动力学建模以支持剂量选择。一旦分析完成，将发布综合报告。</p>
</div><p>The company expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in a targeted patient population affected by chronic stress-related psychiatric disorders. Additional details on study design and endpoints will be communicated in the coming months.</p>
<div class="lb-trans"><p>该公司预计将在 2026 年初启动第二阶段研究，以评估 PT00114 在受慢性压力相关精神疾病影响的目标患者群体中的效果。关于研究设计和终点的更多细节将在未来几个月内公布。</p>
</div><p><strong>About Protagenic Therapeutics, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Protagenic Therapeutics, Inc.</strong></p>
</div><p>Protagenic Therapeutics, Inc. (NASDAQ:PTIX) is a biopharmaceutical company focused on developing innovative peptide-based therapeutics targeting the biological pathways underlying stress-related neurological and mood disorders. The company's lead compound, PT00114, is a synthetic analog of a naturally occurring brain peptide that helps regulate the body's stress response and emotional equilibrium.</p>
<div class="lb-trans"><p>Protagenic Therapeutics, Inc.（纳斯达克代码：PTIX）是一家专注于开发创新的基于肽的疗法，针对压力相关的神经和情绪障碍的生物途径。该公司的主要化合物 PT00114 是一种合成类自然脑肽的类似物，有助于调节身体的压力反应和情绪平衡。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>Statements in this press release contain &#34;forward-looking statements&#34; within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as &#34;projects,&#34; &#34;may,&#34; &#34;will,&#34; &#34;could,&#34; &#34;would,&#34; &#34;should,&#34; &#34;believes,&#34; &#34;expects,&#34; &#34;anticipates,&#34; &#34;estimates,&#34; &#34;intends,&#34; &#34;plans,&#34; &#34;potential,&#34; &#34;promise&#34; or similar references to future periods. Examples of forward-looking statements in this current report include, without limitation, statements regarding the Company's expected filing of its Quarterly Report on Form 10-Q, the Company's planned appeal before the Panel, and the continued listing of the Company's securities pending the appeal. Forward-looking statements are statements that are not historical facts nor assurances of future performance. Instead, they are based on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks and uncertainties, and actual results may differ materially from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, without limitation, that there can be no assurance that the Company will file the Form 10-Q, that there can be no assurance that the Company will otherwise meet Nasdaq compliance standards, that there can be no assurance that Nasdaq will grant the Company any relief from delisting as necessary or whether the Company can agree to or ultimately meet applicable Nasdaq requirements for any such relief, and the other important factors described under the caption &#34;Risk Factors&#34; in the Company's filings with the SEC. Any forward-looking statement made by the Company in this current report is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, the Company expressly disclaims any obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.</p>
<div class="lb-trans"><p>本新闻稿中的声明包含美国联邦证券法意义上的&#34;前瞻性声明&#34;。前瞻性声明可以通过诸如&#34;项目&#34;、&#34;可能&#34;、&#34;将&#34;、&#34;可以&#34;、&#34;会&#34;、&#34;应该&#34;、&#34;相信&#34;、&#34;期望&#34;、&#34;预期&#34;、&#34;估计&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;潜在&#34;、&#34;承诺&#34;或类似的未来时期的参考词来识别。本报告中的前瞻性声明的示例包括但不限于关于公司预计提交其 10-Q 季度报告的声明、公司计划在小组面前提出上诉的声明，以及公司证券在上诉期间的持续上市。前瞻性声明不是历史事实或未来表现的保证。相反，它们基于公司对其业务未来、未来计划、战略、预测、预期事件和趋势、经济及其他未来条件的当前信念、期望和假设。由于前瞻性声明涉及未来，因此它们受到固有风险和不确定性的影响，实际结果可能与前瞻性声明中所述的结果有重大差异。可能导致实际结果不同的重要因素包括但不限于，无法保证公司将提交 10-Q 表格，无法保证公司将满足纳斯达克合规标准，无法保证纳斯达克将给予公司任何必要的退市救济，或公司是否能够同意或最终满足任何此类救济的适用纳斯达克要求，以及在公司向 SEC 提交的文件中描述的其他重要因素。公司在本报告中所做的任何前瞻性声明仅基于当前可用的信息，并仅在声明之日有效。除非适用法律要求，否则公司明确不承担公开更新任何前瞻性声明的义务，无论是书面还是口头，可能会不时做出，无论是由于新信息、未来发展还是其他原因。</p>
</div><p><strong>Company Contact:</strong></p>
<div class="lb-trans"><p><strong>公司联系方式：</strong></p>
</div><p>Alexander K. Arrow, MD, CFA</p>
<div class="lb-trans"><p>Alexander K. Arrow, MD, CFA</p>
</div><p>Chief Financial Officer</p>
<div class="lb-trans"><p>首席财务官</p>
</div><p>Protagenic Therapeutics, Inc.</p>
<div class="lb-trans"><p>Protagenic Therapeutics, Inc.</p>
</div><p>149 Fifth Ave, Suite 500, New York, NY 10010</p>
<div class="lb-trans"><p>149 Fifth Ave, Suite 500, New York, NY 10010</p>
</div><p>Tel: 213-260-4342</p>
<div class="lb-trans"><p>电话：213-260-4342</p>
</div><p>Email: alex.arrow@protagenic.com</p>
<div class="lb-trans"><p>电子邮件：alex.arrow@protagenic.com</p>
</div><p><strong>SOURCE:</strong> Protagenic Therapeutics, Inc.</p>
<div class="lb-trans"><p><strong>来源：</strong> Protagenic Therapeutics, Inc.</p>
</div><p>View the original press release on ACCESS Newswire</p>
<div class="lb-trans"><p>查看原始新闻稿，请访问 ACCESS Newswire</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTExNTc4OA" alt="" original-src="https://app.accessnewswire.com/img.ashx?id=1115788"/></p>

PT00114 多剂量研究第一阶段结果 | PTIX 股票新闻