<p>西班牙的监管批准推动了随机、安慰剂对照研究；患者在没有治疗中断的情况下，EGFR 抑制剂皮肤毒性显著减少</p>
<p>, /PRNewswire/ -- <strong>Hoth Therapeutics, Inc. (NASDAQ: HOTH)</strong>，一家临床阶段生物制药公司，今天宣布已获得西班牙的监管授权，进行 HT-001 的 2a 期 CLEER 试验，同时报告了令人鼓舞的中期临床结果，显示出在经历 EGFR 抑制剂相关皮肤毒性的癌症患者中具有显著的疗效和安全性。</p>
<p>该授权支持 Hoth 的随机、安慰剂对照、剂量范围 2a 期研究的持续推进，评估 HT-001 在治疗与表皮生长因子受体（EGFR）抑制剂疗法相关的皮肤毒性方面的效果。</p>
<p><strong>中期临床结果突显强劲的疗效信号</strong></p>
<p>正在进行的研究的初步数据显示：</p>
<ul>
<li>患者达到了主要疗效终点，皮疹严重程度在第 6 周降低到临床可管理水平（ARIGA ≤1）</li>
<li>超过 65% 的患者报告疼痛和瘙痒显著减少</li>
<li>零患者需要减少剂量或中断其基础 EGFR 抑制剂癌症治疗</li>
<li>安全性良好，未观察到限制治疗的严重不良事件</li>
</ul>
<p>这些发现表明 HT-001 可能使患者能够更长时间地接受拯救生命的癌症治疗，解决了当前肿瘤治疗方案的一个主要限制。</p>
<p><strong>监管势头 + 临床验证</strong>&#34;监管进展与强劲的临床信号相结合，帮助为西班牙的患者开辟了新的途径，&#34;Hoth Therapeutics 首席执行官 Robb Knie 表示。&#34;在展示出显著的患者获益的同时获得欧洲授权，进一步强化了我们对 HT-001 有潜力成为肿瘤学中关键支持性治疗的信念。&#34;</p>
<p>西班牙的授权标志着 Hoth 在欧洲战略中的重要一步，并支持在其他地区的持续试验执行和扩展。</p>
<p><strong>关于 CLEER 试验</strong> CLEER 试验（通过规避 EGFR 抑制剂反应延长化疗）是一项 2a 期随机、安慰剂对照、平行、剂量范围研究，评估 HT-001 在经历 EGFR 抑制剂相关皮肤毒性的患者中的效果。</p>
<p><strong>关于 HT-001</strong> HT-001 是一种新型局部治疗药物，旨在针对与癌症治疗引起的皮肤毒性相关的炎症通路，旨在改善耐受性并实现不间断治疗。</p>
<p><strong>关于 Hoth Therapeutics, Inc.</strong></p>
<p>Hoth Therapeutics 是一家临床阶段生物制药公司，致力于开发创新、具有影响力和突破性的治疗方案，旨在改善患者的生活质量。我们是早期制药研究和开发的催化剂，将药物从实验室提升到临床前和临床测试。通过以患者为中心的方法，我们与科学家、临床医生和关键意见领袖团队合作，寻求和研究具有巨大潜力的治疗方案，以创造突破并多样化治疗选择。欲了解更多信息，请访问 https://ir.hoththerapeutics.com/ 。</p>
<p><strong>前瞻性声明</strong> 本新闻稿包含基于 Hoth 当前预期的前瞻性声明，这些声明可能构成 1995 年《私人证券诉讼改革法案》及其他联邦证券法下安全港条款的前瞻性声明，并且受到重大风险、不确定性和假设的影响。这些声明涉及 Hoth 的商业策略；监管提交的时间；获得和维持现有产品候选者及我们可能开发的任何其他产品候选者的监管批准的能力，以及我们可能获得的任何批准下的标签；临床试验的时间和成本，以及其他费用的时间和成本；我们产品的市场接受度；当前冠状病毒大流行或任何其他健康流行病对我们业务、临床试验、研究项目、医疗系统或全球经济整体的最终影响；我们的知识产权；我们对第三方组织的依赖；我们的竞争地位；我们的行业环境；我们预期的财务和运营结果，包括预期的收入来源；我们对可用市场规模、产品益处、产品定价和产品推出时间的假设；管理层对未来收购的预期；关于我们的目标、意图、计划和预期的声明，包括新产品和市场的推出；以及我们的现金需求和融资计划。有许多因素可能导致实际事件与这些前瞻性声明所指示的情况存在重大差异。您不应过于依赖这些前瞻性声明，这些声明中包含诸如 “可能”、“相信”、“预期”、“打算”、“估计”、“期望”、“可能”、“继续”、“预测”、“潜在”、“项目” 或类似术语、这些术语的变体或其否定形式等词汇。尽管公司相信前瞻性声明中反映的预期是合理的，但公司无法保证这些结果。Hoth 可能无法实现其预期，其信念可能并不正确。实际结果可能因各种重要因素而与这些前瞻性声明所指示的情况存在重大差异，包括但不限于市场条件以及在 Hoth 最近的 10-K 表格年度报告和 Hoth 向美国证券交易委员会提交的其他文件中描述的 “风险因素” 部分。所有这些声明仅在作出时有效。因此，前瞻性声明应仅视为 Hoth 当前的计划、估计和信念。投资者不应对前瞻性声明过于依赖。Hoth 无法保证未来的结果、事件、活动水平、表现或成就。Hoth 不承担并明确拒绝任何更新、重新发布或修订任何前瞻性声明以反映新信息、未来事件或情况或反映意外事件发生的义务，除非适用法律要求。</p>
<p><strong>投资者联系：</strong></p>
<p>LR Advisors LLC</p>
<p>电子邮件：[email protected]</p>
<p>www.hoththerapeutics.com</p>
<p>电话：(678) 570-6791</p>
<p>来源 Hoth Therapeutics, Inc.</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9Tlk1MTY1MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUxNjE3UFJfTkVXU19VU1BSX19fX19OWTUxNjUz?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://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9Tlk1MTY1MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUxNjE3UFJfTkVXU19VU1BSX19fX19OWTUxNjUz"/></p>

HOTH

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<p>Hoth Therapeutics, Inc. 已获得西班牙的监管授权，进行其 HT-001 的 2a 期 CLEER 试验，旨在治疗癌症患者因 EGFR 抑制剂引起的皮肤毒性。中期结果显示出显著的疗效，超过 65% 的患者报告疼痛和瘙痒减轻，并且没有治疗中断。试验的成功支持了 Hoth 在欧洲扩展临床研究的战略，突显了 HT-001 作为肿瘤学支持治疗的潜力</p>

<p><em>Regulatory Clearance in Spain Advances Randomized,</em> <em>Placebo-Controlled Study; Patients Show Meaningful Reductions in EGFR-Inhibitor Skin Toxicities with No Treatment Disruptions</em></p>
<div class="lb-trans"><p>西班牙的监管批准推动了随机、安慰剂对照研究；患者在没有治疗中断的情况下，EGFR 抑制剂皮肤毒性显著减少</p>
</div><p>, /PRNewswire/ -- <strong>Hoth Therapeutics, Inc. (NASDAQ: HOTH)</strong>, a clinical-stage biopharmaceutical company, today announced that it has secured regulatory authorization in Spain for its Phase 2a CLEER Trial of HT-001, while concurrently reporting encouraging interim clinical results demonstrating meaningful efficacy and safety in cancer patients experiencing EGFR inhibitor-associated skin toxicities.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- <strong>Hoth Therapeutics, Inc. (NASDAQ: HOTH)</strong>，一家临床阶段生物制药公司，今天宣布已获得西班牙的监管授权，进行 HT-001 的 2a 期 CLEER 试验，同时报告了令人鼓舞的中期临床结果，显示出在经历 EGFR 抑制剂相关皮肤毒性的癌症患者中具有显著的疗效和安全性。</p>
</div><p>The authorization supports the continued advancement of Hoth's randomized, placebo-controlled, dose-ranging Phase 2a study evaluating HT-001 for the treatment of dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor therapies.</p>
<div class="lb-trans"><p>该授权支持 Hoth 的随机、安慰剂对照、剂量范围 2a 期研究的持续推进，评估 HT-001 在治疗与表皮生长因子受体（EGFR）抑制剂疗法相关的皮肤毒性方面的效果。</p>
</div><p><strong>Interim Clinical Results Highlight Strong Efficacy Signal</strong></p>
<div class="lb-trans"><p><strong>中期临床结果突显强劲的疗效信号</strong></p>
</div><p>Preliminary data from the ongoing study indicate:</p>
<div class="lb-trans"><p>正在进行的研究的初步数据显示：</p>
</div><ul>
<li>Patients achieved the primary efficacy endpoint, with rash severity reduced to clinically manageable levels (ARIGA ≤1) by Week 6</li>
<li>Over 65% of patients reported meaningful reductions in pain and itching</li>
<li>Zero patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapy</li>
<li>Favorable safety profile, with no treatment-limiting adverse events observed</li>
</ul>
<div class="lb-trans"><ul>
<li>患者达到了主要疗效终点，皮疹严重程度在第 6 周降低到临床可管理水平（ARIGA ≤1）</li>
<li>超过 65% 的患者报告疼痛和瘙痒显著减少</li>
<li>零患者需要减少剂量或中断其基础 EGFR 抑制剂癌症治疗</li>
<li>安全性良好，未观察到限制治疗的严重不良事件</li>
</ul>
</div><p>These findings suggest that HT-001 may enable patients to remain on life-saving cancer therapies longer, addressing a major limitation of current oncology treatment regimens.</p>
<div class="lb-trans"><p>这些发现表明 HT-001 可能使患者能够更长时间地接受拯救生命的癌症治疗，解决了当前肿瘤治疗方案的一个主要限制。</p>
</div><p><strong>Regulatory Momentum + Clinical Validation</strong>&#34;Regulatory advancement paired with strong clinical signals has helped open up a new avenue for patients in Spain,&#34; said Robb Knie, Chief Executive Officer of Hoth Therapeutics. &#34;Securing European authorization while demonstrating meaningful patient benefit reinforces our belief that HT-001 has the potential to become a critical supportive care therapy in oncology.&#34;</p>
<div class="lb-trans"><p><strong>监管势头 + 临床验证</strong>&#34;监管进展与强劲的临床信号相结合，帮助为西班牙的患者开辟了新的途径，&#34;Hoth Therapeutics 首席执行官 Robb Knie 表示。&#34;在展示出显著的患者获益的同时获得欧洲授权，进一步强化了我们对 HT-001 有潜力成为肿瘤学中关键支持性治疗的信念。&#34;</p>
</div><p>The Spain authorization marks an important step in Hoth's European strategy and supports continued trial execution and expansion across additional regions.</p>
<div class="lb-trans"><p>西班牙的授权标志着 Hoth 在欧洲战略中的重要一步，并支持在其他地区的持续试验执行和扩展。</p>
</div><p><strong>About the CLEER Trial</strong> The CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions) is a Phase 2a randomized, placebo-controlled, parallel, dose-ranging study evaluating HT-001 in patients experiencing EGFR inhibitor-related dermatologic toxicities.</p>
<div class="lb-trans"><p><strong>关于 CLEER 试验</strong> CLEER 试验（通过规避 EGFR 抑制剂反应延长化疗）是一项 2a 期随机、安慰剂对照、平行、剂量范围研究，评估 HT-001 在经历 EGFR 抑制剂相关皮肤毒性的患者中的效果。</p>
</div><p><strong>About HT-001</strong> HT-001 is a novel topical therapeutic designed to target inflammatory pathways associated with cancer therapy-induced skin toxicities, with the goal of improving tolerability and enabling uninterrupted treatment.</p>
<div class="lb-trans"><p><strong>关于 HT-001</strong> HT-001 是一种新型局部治疗药物，旨在针对与癌症治疗引起的皮肤毒性相关的炎症通路，旨在改善耐受性并实现不间断治疗。</p>
</div><p><strong>About Hoth Therapeutics, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Hoth Therapeutics, Inc.</strong></p>
</div><p>Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/ .</p>
<div class="lb-trans"><p>Hoth Therapeutics 是一家临床阶段生物制药公司，致力于开发创新、具有影响力和突破性的治疗方案，旨在改善患者的生活质量。我们是早期制药研究和开发的催化剂，将药物从实验室提升到临床前和临床测试。通过以患者为中心的方法，我们与科学家、临床医生和关键意见领袖团队合作，寻求和研究具有巨大潜力的治疗方案，以创造突破并多样化治疗选择。欲了解更多信息，请访问 https://ir.hoththerapeutics.com/ 。</p>
</div><p><strong>Forward-Looking Statement</strong> This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as &#34;could,&#34; &#34;believe,&#34; &#34;anticipate,&#34; &#34;intend,&#34; &#34;estimate,&#34; &#34;expect,&#34; &#34;may,&#34; &#34;continue,&#34; &#34;predict,&#34; &#34;potential,&#34; &#34;project&#34; or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled &#34;Risk Factors&#34; in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.</p>
<div class="lb-trans"><p><strong>前瞻性声明</strong> 本新闻稿包含基于 Hoth 当前预期的前瞻性声明，这些声明可能构成 1995 年《私人证券诉讼改革法案》及其他联邦证券法下安全港条款的前瞻性声明，并且受到重大风险、不确定性和假设的影响。这些声明涉及 Hoth 的商业策略；监管提交的时间；获得和维持现有产品候选者及我们可能开发的任何其他产品候选者的监管批准的能力，以及我们可能获得的任何批准下的标签；临床试验的时间和成本，以及其他费用的时间和成本；我们产品的市场接受度；当前冠状病毒大流行或任何其他健康流行病对我们业务、临床试验、研究项目、医疗系统或全球经济整体的最终影响；我们的知识产权；我们对第三方组织的依赖；我们的竞争地位；我们的行业环境；我们预期的财务和运营结果，包括预期的收入来源；我们对可用市场规模、产品益处、产品定价和产品推出时间的假设；管理层对未来收购的预期；关于我们的目标、意图、计划和预期的声明，包括新产品和市场的推出；以及我们的现金需求和融资计划。有许多因素可能导致实际事件与这些前瞻性声明所指示的情况存在重大差异。您不应过于依赖这些前瞻性声明，这些声明中包含诸如 “可能”、“相信”、“预期”、“打算”、“估计”、“期望”、“可能”、“继续”、“预测”、“潜在”、“项目” 或类似术语、这些术语的变体或其否定形式等词汇。尽管公司相信前瞻性声明中反映的预期是合理的，但公司无法保证这些结果。Hoth 可能无法实现其预期，其信念可能并不正确。实际结果可能因各种重要因素而与这些前瞻性声明所指示的情况存在重大差异，包括但不限于市场条件以及在 Hoth 最近的 10-K 表格年度报告和 Hoth 向美国证券交易委员会提交的其他文件中描述的 “风险因素” 部分。所有这些声明仅在作出时有效。因此，前瞻性声明应仅视为 Hoth 当前的计划、估计和信念。投资者不应对前瞻性声明过于依赖。Hoth 无法保证未来的结果、事件、活动水平、表现或成就。Hoth 不承担并明确拒绝任何更新、重新发布或修订任何前瞻性声明以反映新信息、未来事件或情况或反映意外事件发生的义务，除非适用法律要求。</p>
</div><p><strong>Investor Contact:</strong></p>
<div class="lb-trans"><p><strong>投资者联系：</strong></p>
</div><p>LR Advisors LLC</p>
<div class="lb-trans"><p>LR Advisors LLC</p>
</div><p>Email: [email protected]</p>
<div class="lb-trans"><p>电子邮件：[email protected]</p>
</div><p>www.hoththerapeutics.com</p>
<div class="lb-trans"><p>www.hoththerapeutics.com</p>
</div><p>Phone: (678) 570-6791</p>
<div class="lb-trans"><p>电话：(678) 570-6791</p>
</div><p>SOURCE Hoth Therapeutics, Inc.</p>
<div class="lb-trans"><p>来源 Hoth Therapeutics, Inc.</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9Tlk1MTY1MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUxNjE3UFJfTkVXU19VU1BSX19fX19OWTUxNjUz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=NY51653&amp;Transmission_Id=202605051617PR_NEWS_USPR_____NY51653&amp;DateId=20260505"/></p>

16:17 ETHoth Therapeutics Secures European Authorization in Spain for HT-001 Phase 2a Trial as Interim Data Show Strong Efficacy in Cancer Patients

prnewswire

Hoth Therapeutics

Invesco Nasdaq Biotechnology ETF

Hoth Therapeutics 在西班牙获得 HT-001 二期 a 阶段试验的欧洲授权，中期数据显示该药物对癌症患者具有显著疗效