DMT-310

*仅供医学专业人士阅读参考 2025 EADV皮科解读会第二场圆满落幕，三大疾病诊疗迎精准升级 2025年12月6日晚，由琼海博鳌基层卫生健康创新发展中心指导、医学界皮肤频道策划举办的“皮科专家带你看EADV 2025”系列学术会议第二场在云端顺利召开。本次会议延续了首届的前沿视野与专业深度，聚焦中重度斑块状银屑病、玫瑰痤疮与慢性瘙痒管理三大皮肤科核心临床议题，吸引了来自全国各地的皮肤科医师、学者线上参与。会议由华北理工大学孙良丹教授担任主席，特邀北京大学第一医院余进教授、华北理工大学附属医院杨洁教授、河北医科大学第一医院张国强教授进行专题报告，共同解读2025年欧洲皮肤病与性病学会（EADV）年会的最新科研进展与临床启示。 学术引领，推动中国皮肤科精准化进程 会议伊始，大会主席华北理工大学孙良丹教授发表致辞。孙良丹教授指出，EADV年会虽已落幕，但其释放的学术能量与临床启示仍需通过专业视角进行及时梳理与转化。本次系列会议旨在将国际前沿声音转化为适合中国患者的本土策略，推动我国皮肤科诊疗向精准化、规范化迈进。 孙良丹教授强调，当前皮肤科治疗已进入“靶向时代”，从JAK抑制剂在炎症性皮肤病中的循证证据，到生物制剂在银屑病全程管理中的策略优化，从瘙痒机制研究的突破到玫瑰痤疮分类治疗与长期管理理念的更新，国际进展不断拓展疾病认知边界，也重塑着临床路径。他期待通过本次会议的思维碰撞与经验交流，与会者不仅能看清国际前沿，更能走实中国皮肤科治疗的“进阶之路”。 氘可来昔替尼——中重度斑块状银屑病系统治疗的口服优选 北京大学第一医院余进教授以“氘可来昔替尼：中重度斑块状银屑病患者启动系统治疗的优选药”为题，从作用机制、适用人群、疗效数据、安全性及用药便捷性等维度展开深入解读。 精准抑制TYK2且已纳入医保，提升治疗可及性 余进教授指出，银屑病治疗虽已进入生物制剂时代，但注射不便、部分患者疗效衰减等问题仍存，口服药物的补充至关重要。氘可来昔替尼是全球首个且唯一的口服高选择性酪氨酸激酶2（TYK2）变构抑制剂，可精准抑制TYK2调节结构域，靶向阻断IL-23/17核心轴，且在临床剂量下对 JAK1、JAK2、JAK3抑制作用可忽略不计，无泛JAK抑制剂的黑框警告。该药物2022年9月获FDA批准，2023年10月国内上市，2024年11月纳入医保，医保后每日仅需16元，大幅提升了药物可及性。 适配3类典型场景满足不同患者诊疗需求 余进教授结合三类典型临床场景，明确了氘可来昔替尼的适用人群：一是职场与家庭压力大、无法频繁就医的中青年四肢斑块患者；二是头皮等顽固部位受累、对传统药物有安全顾虑的老年患者；三是需长期治疗、无法耐受频繁监测的体力工作者。氘可来昔替尼的口服便捷性、特殊部位疗效及安全性，可精准匹配这类患者的诊疗需求。 24周PASI 75的应答率为72.4%，疗效可维持至52周 在疗效方面，以中国为主的亚洲Ⅲ期临床研究显示，氘可来昔替尼治疗24周时PASI 75的应答率达72.4%，PASI 90的应答率48.3%，疗效可维持至52周无衰减；国内真实世界研究中，16周PASI 75的应答率高达90%，四肢、头皮等部位皮损均可实现完全清除。安全性方面，短期不良反应以轻度咽炎、头痛为主，消化道不适发生率低于阿普米司特，因不良事件停药率仅2.4%；5年长期数据证实，其不良事件发生率随用药时长逐年下降，无严重感染、血栓等特殊风险。 每日一次口服，简化流程提升长期依从性 氘可来昔替尼为每日一次口服制剂，无需剂量滴定或调整，可随餐或空腹服用，食物不影响药效；治疗前仅需筛查结核，无活动性肺结核即可使用，对乙肝等肝病患者无需特殊干预，仅需维持原有基础治疗，大幅简化了诊疗流程，有助于提升患者长期用药依从性。 余进教授总结指出，氘可来昔替尼以其高效、安全、口服便捷、医保覆盖的综合优势，已成为中重度斑块状银屑病系统治疗的重要优选，尤其适合作为生物制剂之外的补充或替代策略，丰富了个体化治疗选择。 玫瑰痤疮——从分型到表型，迈向精准管理新时代 华北理工大学附属医院杨洁教授以“玫瑰痤疮治疗新方法与新进展”为题，结合2025年 EADV共识，从诊疗模式转变、发病机制、治疗手段及未来展望等方面，带来了玫瑰痤疮诊疗的前沿认知，强调该病已进入“表型驱动、靶向治疗”的精准管理阶段。 从“分型”到“表型”，实现精准靶向 杨洁教授指出，传统玫瑰痤疮采用四分法（丘疹脓疱型、红斑毛细血管扩张型、肥大增生型、眼型），为基础诊疗提供了框架，但存在诊疗笼统的局限。2025年EADV共识强调“表型诊断”，即从患者具体的体征与症状（如持续性红斑、阵发性潮红、毛细血管扩张、眼部不适等）出发，绘制个性化“症状地图”。  这一转变让治疗目标更精准，核心目标为控制炎症、减轻持续性红斑，长期目标为延缓疾病进展、改善不可逆损伤，终极目标则是提升患者生活质量、实现长期病情稳定，也让医患沟通更具针对性，明确疾病可长期缓解但无法根治的现状，帮助患者建立合理预期。 多因素互作构成玫瑰痤疮复杂发病网络 杨洁教授阐释，玫瑰痤疮并非单一通路疾病，而是遗传、神经、血管、免疫、微生物多重因素互作的结果： 皮肤屏障受损与外部触发：患者存在先天屏障脆弱与后天易损的基础，经表皮水分丢失增加、角质层薄弱，外界刺激易穿透屏障激活免疫反应，同时暴露神经末梢引发神经源性炎症，形成“屏障受损－炎症激活－屏障进一步破坏”的循环。 微生物作用：毛囊蠕形螨过度增殖、死亡后释放芽孢杆菌，以及皮肤与肠道菌群失衡，均可触发免疫炎症反应，且肠脑皮肤轴的紊乱还会关联患者的情绪状态，加重病情。 免疫失调：玫瑰痤疮存在Th1/Th17免疫应答异常，皮脂腺丰富区域易形成炎症微环境，角质形成细胞释放的抗菌肽会过度激活促炎因子，放大炎症反应；KLK5-抗菌肽LL-37炎症通路则是连接外部触发与先天免疫缺陷的“分子枢纽”。 神经血管功能紊乱：患者存在神经系统高反应性，TRPV1/2离子通道对温度、化学刺激敏感，微小刺激即可引发神经信号异常与血管舒张，表现为潮红、持续性红斑，同时神经肽会招募免疫细胞与肥大细胞，加剧局部炎症。 肥大细胞作用：作为核心效应器与系统连接器，肥大细胞可驱动慢性炎症，并通过调控神经与血管，引发红斑、肿胀等症状，是玫瑰痤疮多机制网络的关键节点。 基础护理联合靶向药物，构建长期管理策略 针对上述机制，杨洁教授介绍了多项新型疗法： 基础护理与患者教育：科学防晒、全方位屏障修复是玫瑰痤疮治疗的基础，需指导患者规避诱发因素，建立长期治疗的认知。 局部药物：FDA 批准的甲硝唑、壬二酸、伊维菌素等药物可满足基础抗炎抗菌需求；新型5%封装过氧化苯甲酰乳膏（EBPO）兼具高效与温和的优势，可适配传统外用药不耐受的患者；1.5%米诺环素泡沫剂等新剂型也为临床提供了更多选择。 系统药物：亚抗菌剂量的多西环素、米诺环素可发挥抗炎作用且不易耐药，缓释剂型还能降低复发率；针对免疫失调的苏金单抗等IL-17抑制剂、钙调磷酸酶抑制剂，以及针对神经血管紊乱的溴莫尼定、羟甲唑啉等药物，可靶向改善对应症状；氨苯酚磺胺类药物则可通过抑制中性粒细胞发挥抗炎作用。 新兴疗法与在研药物：JAK/TYK2抑制剂虽暂未获批用于玫瑰痤疮，但理论上具备潜在治疗价值；DMT310凝胶（靶向TLR2通路）、曲美替尼（改善神经元性红斑）、依瑞奈尤单抗（抗CGRP受体，改善潮红）等在研药物，以及微滴注射肉毒毒素等新疗法，为玫瑰痤疮治疗提供了新方向。 杨洁教授强调，玫瑰痤疮治疗是“持久战”，需结合患者表型，采用“基础护理+靶向药物+长期管理”的联合策略，实现病情稳定。 瘙痒——从症状到疾病，慢病管理迎来靶向药物新突破 河北医科大学第一医院张国强教授结合2025年EADV大会相关成果，以“瘙痒的治疗与管理”为题，完成了从定义更新到诊疗策略的全面解读，推动了临床对瘙痒的认知从“伴随症状”向“独立疾病”的转变。 重新定义疾病属性，建立多维度评估体系 2024年多学科全球共识明确，瘙痒是“出现于皮肤或黏膜、诱发搔抓欲望的不愉快感受”，持续超过6周即为慢性瘙痒，常伴随神经通路重塑，严重影响生活质量。评估应涵盖： 病因筛查：皮肤源性（如特应性皮炎、银屑病、荨麻疹）、系统性（如肝肾疾病、糖尿病、恶性肿瘤）、神经性（如带状疱疹后神经病变）、心因性四大类，无明确病因的则为原因不明的慢性瘙痒。 严重程度：在瘙痒评估环节，欧洲慢性瘙痒指南推荐采用数字评定量表（NRS）或视觉模拟量表（VAS）量化瘙痒强度，通过患者对24小时内最严重或平均瘙痒程度的打分实现精准评估。 生活质量影响：包括睡眠、心理、社交等多维度。 阶梯化综合管理，靶向药物成难治病例新方向 张国强教授强调，瘙痒管理需采取阶梯化、综合化策略： 非药物措施：作为基础干预手段，非药物措施包括穿着柔软透气衣物、保持环境凉爽、使用温和无刺激清洁及保湿产品、避免热水烫洗与过度搔抓；同时需规避干燥、精神紧张、刺激性饮食等诱发因素，通过结构化教育与放松训练打破瘙痒-搔抓循环，例如瘙痒时以拍打代替搔抓、通过工作或兴趣转移注意力。 药物治疗：遵循阶梯治疗原则，轻度瘙痒可选用外用糖皮质激素、钙调磷酸酶抑制剂或H1抗组胺药；疗效欠佳时可加用外用辣椒素、皮损内激素注射或光疗；中重度瘙痒则可升级至加巴喷丁、普瑞巴林、抗抑郁药、免疫抑制剂等；对于难治性病例，新型靶向药物已展现出显著优势。 多款靶向新药亮相，为瘙痒治疗提供新选择 多项新药在难治性瘙痒中显示出卓越潜力： 生物制剂：度普利尤单抗（抗IL-4/13）、奈莫利珠单抗（抗IL-31受体）等在结节性痒疹等领域疗效显著； 小分子抑制剂：JAK抑制剂（如乌帕替尼、阿布昔替尼）、KIT抑制剂、神经激肽-1受体拮抗剂等，在病因不明或难治性慢性瘙痒中应答良好； 外用创新：如芦可替尼乳膏在瘙痒控制中也表现出价值。 病因不明的瘙痒，生物标志物指导个体化治疗 对于无明确原发皮损的慢性瘙痒，治疗更为棘手。轻度病例可采用润肤剂、钙调磷酸酶抑制剂、中医药或心理治疗；中度病例可加用局部氯胺酮、阿米替林-利多卡因制剂；重度病例则需系统使用阿片受体调节剂、抗抑郁药、光疗或靶向药物。 临床研究显示，生物制剂与小分子靶向药对这类患者具有良好疗效，且伴有IgE增高或嗜酸粒细胞增多的患者应答率更高，这也提示未来可通过生物标志物指导个体化治疗，进一步提升诊疗精准度。 总结 本次“皮科专家带你看 2025 EADV”第二场专题解读会，通过三位专家的深度分享，完成了对中重度银屑病、玫瑰痤疮、慢性瘙痒三大领域国际前沿成果的本土化解读。氘可来昔替尼的出现为银屑病口服系统治疗提供了优选方案，玫瑰痤疮迈入了表型导向的精准治疗时代，瘙痒诊疗则实现了从“症状”到“疾病”的认知跨越，三大专题的进展共同标志着皮肤科诊疗已全面进入“精准靶向+全程管理”新阶段。 *"医学界"力求所发表内容专业、可靠，但不对内容的准确性做出承诺；请相关各方在采用或以此作为决策依据时另行核查。 ↓↓↓点击「阅读原文」学习更多临床技能

- Dermata announced a strategic pivot to develop and commercialize over-the-counter (OTC) skin care treatments - - Dermata plans to launch its first OTC product, a once weekly acne kit with its Spongilla technology, in the middle of 2026 - SAN DIEGO, CALIFORNIA / ACCESS Newswire / November 14, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today highlighted recent corporate progress and reported financial results for the third quarter ended September 30, 2025. "At Dermata, our mission is to bring scientifically developed innovation directly to those who need it most," said Gerry Proehl, Chairman, President, and CEO of Dermata. "Our recent strategic pivot into over-the-counter skincare reflects that same commitment - delivering clinical-grade innovation intended to meet growing consumer demand for accessible, effective, and easy to use dermatologic solutions. The planned launch of our once-weekly acne kit in mid-2026 marks the initial step toward building a scalable portfolio of products that merge medical-grade science with everyday convenience. We see this as more than a product launch - it is the beginning of a new growth chapter where we plan to leverage our deep dermatological know-how, scientific credibility, and innovative Spongilla technology to reach consumers directly. By bridging the gap between prescription care and at-home skincare, we believe we are well positioned to succeed in a rapidly expanding category and drive meaningful long-term value for both patients and shareholders," concluded Mr. Proehl. Corporate Highlights Announced strategic pivot to OTC dermatology company. In September 2025, Dermata announced that it was making a strategic shift from developing prescription dermatology products to developing and launching an OTC pharmaceutical product line to treat multiple skin diseases. The Company is currently working on branding, packaging, and manufacturing to prepare for the expected launch of their first OTC product, a once-weekly acne kit, in the middle of 2026. The Company plans to sell the acne kit directly to consumers, estheticians and dermatologists for in-office treatments. Announced strategic pivot to OTC dermatology company. In September 2025, Dermata announced that it was making a strategic shift from developing prescription dermatology products to developing and launching an OTC pharmaceutical product line to treat multiple skin diseases. The Company is currently working on branding, packaging, and manufacturing to prepare for the expected launch of their first OTC product, a once-weekly acne kit, in the middle of 2026. The Company plans to sell the acne kit directly to consumers, estheticians and dermatologists for in-office treatments. Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. The STAR-1 study tested the Company's Spongilla technology as a treatment for moderate-to-severe acne, adding to prior Phase 2a/2b studies where XYNGARI™ achieved statistically significant separation from placebo at all time points. Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. The STAR-1 study tested the Company's Spongilla technology as a treatment for moderate-to-severe acne, adding to prior Phase 2a/2b studies where XYNGARI™ achieved statistically significant separation from placebo at all time points. Anticipated Upcoming Milestones Announce brand name and brand identity for new OTC product portfolio. The Company is currently working with a branding agency to conduct market research to identify white space in the dermatology market. Based on this research, the Company intends to create a unique brand identity and brand name that embodies its innovative Spongilla technology as the foundation for multiple OTC dermatology products. Announce brand name and brand identity for new OTC product portfolio. The Company is currently working with a branding agency to conduct market research to identify white space in the dermatology market. Based on this research, the Company intends to create a unique brand identity and brand name that embodies its innovative Spongilla technology as the foundation for multiple OTC dermatology products. Launch first OTC product, a once-weekly acne kit, in the middle of 2026. The Company is underway with developing its first OTC product, a once-weekly acne kit. Based on the timeline for manufacturing and brand development, the Company anticipates being ready to launch the acne kit in the middle of 2026. Launch first OTC product, a once-weekly acne kit, in the middle of 2026. The Company is underway with developing its first OTC product, a once-weekly acne kit. Based on the timeline for manufacturing and brand development, the Company anticipates being ready to launch the acne kit in the middle of 2026. Third Quarter 2025 Financial Results As of September 30, 2025, the Company had $4.7 million in cash and cash equivalents, compared to $3.2 million as of December 31, 2024. The $1.5 million increase in cash and cash equivalents for the nine months ended September 30, 2025, resulted from approximately $7.9 million of net financing proceeds offset by $6.4 million of cash used in operations. The Company expects its current cash resources to be sufficient to fund operations into the second quarter of 2026. Research and development expenses were $0.5 million for the quarter ended September 30, 2025, compared to $2.4 million for the quarter ended September 30, 2024. The $1.9 million decrease in research and development expenses was primarily the result of $1.9 million of decreased clinical expenses from the XYNGARI™ STAR-1 acne study, which completed enrollment during the fourth quarter of 2024 and completed expenses during the second quarter of 2025. Selling, general and administrative expenses were $1.3 million for the quarter ended September 30, 2025, compared to $0.8 million for the same period in 2024. The $0.4 million increase in selling, general and administrative expenses resulted from $0.5 million of marketing expenses partially offset by $0.1 million of decreased audit costs. About Dermata Therapeutics Dermata Therapeutics is a scientific leader in dermatologic solutions that recently announced a strategic pivot to begin focusing on the development and distribution of OTC pharmaceutical skin treatments. The Company is currently developing a once-weekly acne kit that utilizes an active ingredient from the OTC acne monograph in combination with the Company's Spongilla technology to create a unique treatment option for patients suffering with acne. The Company plans to launch this initial acne kit in the middle of 2026 with additional product candidates planned to follow. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: Dermata's shift to prioritize OTC dermatology products; the anticipated benefits of Dermata's strategic shift to prioritize OTC dermatology products, including acceleration of its path to commercialization, reduction of regulatory burdens, and expansion into broader consumer markets; the expected timing and success of any planned or future OTC product launches; and other factors described in the Company's filings with the Securities and Exchange Commission. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. DERMATA THERAPEUTICS, INC. Balance Sheets September 30, 2025 December 31, 2024 (unaudited) $ 4,664 $ 3,162 407 372 5,071 3,534 453 808 658 1,165 1,111 1,973 3,960 1,561 $ 5,071 $ 3,534 DERMATA THERAPEUTICS, INC. Statements of Operations (unaudited) Quarter Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 $ 505 $ 2,401 $ 2,403 $ 6,011 1,256 824 3,470 3,302 1,761 3,225 5,873 9,313 (1,761 ) (3,225 ) (5,873 ) (9,313 ) 69 52 177 176 $ (1,692 ) $ (3,173 ) $ (5,697 ) $ (9,137 ) $ (1.65 ) $ (20.41 ) $ (6.64 ) $ (102.18 ) 1,026,457 155,465 858,015 89,414 $ 8 $ 5 $ 24 $ 247 $ 30 $ 16 $ 91 $ 381 Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released November 14, 2025