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“剑指”雄激素性脱发,特科罗在研创新药物公布临床I期试验最新进展

作者:动脉网 2022-01-05 08:00

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随着现代社会生活节奏加快、工作压力加大,无关老幼也不分男女,脱发已成为新时代的“流行病”。


此前,国家卫健委发布调查的数据显示,截至2020年末我国脱发人群已突破2.52亿人,占人口总数的比例高达18%。在庞大的脱发人群中,又以雄激素性脱发患者数量最多,占比90%以上。换言之,全国有超过2.2亿人患有雄激素性脱发。脱发在欧美国家人群尤为突出,据美国脱发协会调查报告,2/3的美国男性在35岁时都会经历脱发的困扰,到50岁左右的男性脱发现象可高达80%以上。脱发治疗药物具有广阔的市场前景,脱发也需要更加安全有效的毛发再生产品。


为解决脱发人群的困扰,生物医药界也在不断作出努力,力图研发出能从根本上解决雄激素性脱发的创新型药物。


皮肤适应症创新药物研发企业嘉兴特科罗生物科技有限公司(以下简称 “特科罗” www.tkskin.com)就在近日宣布,临床机构已开始在美国为其外用药 TDM-105795招募雄激素性脱发 (AGA) 患者进行Phase Ib 临床试验。有望为脱发患者带来新的治疗手段、让患者受益。


创新原研药临床数据优异


“雄激素性脱发对有效和安全的治疗手段有真正的需求。”据特科罗的首席医疗官 Arthur P. Bertolino博士介绍,TDM-105795在首个临床试验中展示出良好的安全性和耐受性,临床前数据也显示其在动物模型上能高效地诱导毛发生长,“公司对一期临床的结果备受鼓舞”。


据介绍,目前,针对雄激素性脱发的小分子药物鲜有人问津。获得美国FDA批准用于脱发治疗的药物只有米诺地尔(Minoxidil)和非那雄胺(Finasteride)两款药物。


不同于上述两款药物的作用机理,TDM-105795与毛囊细胞内的靶点蛋白结合后能够激活休眠的毛囊干细胞,诱导休眠期毛囊进入生长期、延长生长期、缩短退化期和休眠期,以达到治疗脱发的效果。


据了解,TDM-105795是一款具有全球知识产权保护、国际领先、治疗雄激素性脱发的小分子药物。已进行的动物试验数据显示,TDM-105795起效快,在用药后3-5日毛发增长效果显著,15-18日即可完成整个毛发生长周期,外用能够以剂量依赖的方式强效刺激毛发生长。另外,临床前研究也表明TDM-105795 外用后系统暴露很低,血浆清除半衰期短,能够很好地避免并不需要的全身作用。


此前,该药物临床I期研究申请(IND154722)已获得美国FDA许可并立即在美国进入临床I期研究。


最新消息则显示,特科罗已宣布临床机构开始在美国为TDM-105795招募雄激素性脱发 (AGA) 患者进行Phase Ib临床试验,这一推进是基于此前成功完成了单剂量递增Phase Ia临床试验 (NCT04913519) 。据介绍,根据试验的不良事件、局部皮肤反应,以及用药后生命指征、安全指标化验检测和心电图的基线变化等方面的报告,TDM-105795在Ia临床研究没有发现任何需要警惕的安全问题。


据悉,Phase Ib临床试验标题为 “随机、双盲、安慰剂对照、平行设组、多剂量递增研究以评估 TDM-105795 在健康男性AGA患者中的安全性、耐受性和药代动力学”,是一项为期 28 天的多剂量递增研究,旨在评估重复外用 TDM-105795的安全性、耐受性及药代动力学参数,从而确定用于验证疗效的Phase II 临床试验的最适制剂浓度。


华泰证券此前发布的研报表示,2020年中国脱发诊疗市场近200亿元,其中药物约占7亿元规模,其预计未来十年该市场复合增速将超20%,至2031年国内脱发药物治疗市场规模有望达到155亿元。此外,有欧美脱发患者的巨大人群和市场潜力,手握治疗雄激素性脱发创新型小分子药物的特科罗也将迎来一片蓝海。


专注皮肤病新药研发


“我们对治疗雄激素性脱发 (AGA) 的 TDM-105795项目在临床上取得的进展感到兴奋,同时期待其它针对不同皮肤疾病的管线化合物以类似的方式进入临床,我们希望能为解决该疾病领域的市场需求做出重大贡献。”特科罗首席执行官王增全博士如是称。


公开信息显示,特科罗是一家专注皮肤病新药研发的小分子药物研发型创新企业。公司致力于成为世界领先的皮肤病新药研发平台,研发上市针对各主要皮肤相关疾病的First-in-Class或同类最优的全球新药,为全球患者提供基于全新机理的更高效、更安全、成本更低的新药产品。


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目前,特科罗已在雄激素性脱发以及自身免疫及炎症性皮肤疾病方面,构建了同类首创或同类最佳的药物候选管线。TDM-105795正是特科罗首发生发项目的产品,也是公司推进度最快的产品线。


而在炎症性皮肤病方面,公司专注于针对不同皮肤疾病种类选择具有高度差异化的创新Jak小分子抑制剂药物推进研发,目前已经拥有强大的知识产权基础,多个系列具有明显差异化和竞争特色的化合物在湿疹,银屑病和红斑狼疮等疾病同步推进开发。


其中,湿疹项目初步药效结果显示候选药具有药效明显优势,药效强于已经上市的PDE4抑制剂,且与糖皮激素类药对比有同等药效而没有激素对皮肤的不良副作用反应。湿疹项目预期在2022年第二季度申报临床I期。 公司在银屑病和红斑狼疮的药物候选新品也将逐渐进入临床试验申报阶段。


Technoderma Medicines Announces Progression of TDM-105795 Phase 1 Clinical Trials for Treatment of Androgenetic Alopecia


SHANGHAI – January 5, 2022  Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun recruitment for its second Phase 1 clinical trial of topical TDM-105795 in patients with Androgenetic Alopecia (AGA). This follows successful completion of a single dose escalation study (NCT04913519) in which no material clinical safety issues were demonstrated based on reporting of adverse events, local skin reactions and changes from baseline in vital signs, safety labs, and ECG.


This second clinical trial is a 28-day multiple dose escalation study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia”. Its objectives are to evaluate topical TDM-105795 repeated dose safety and toleration and its pharmacokinetics, in order to define formulation strength(s) appropriate for a proof-of-concept Phase 2 study planned to follow.


“There is a real current need for effective and safe medical options to treat Androgenetic Alopecia,” said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines. “The Company is encouraged by TDM-105795 safety and toleration demonstrated in its first clinical trial and by preclinical data showing robust induction of hair growth in an animal model.”


Dr. Zengquan Wang, Chief Executive Officer at Technoderma Medicines commented, “We are excited about the progress being made with the TDM-105795 AGA program advancing in the clinic. In addition, we look forward to additional pipeline compounds likewise following into the clinic for treatment of various dermatologic diseases. We hope to contribute significantly to addressing the market need in this therapy area.”

About TDM-105795


TDM105795 is a small molecule drug candidate being developed as a topical drug to promote hair growth. Preclinical assessment of TDM105795 indicates that TDM105795 has poor systemic absorption following topical application and a short elimination half-life, features well-suited to avoid unwanted systemic effects. Moreover, in vivo efficacy studies in C3H mice showed that TDM105795 was able to potently stimulate hair growth in a dose-dependent manner when applied topically. This is likely because TDM105795 is able to activate dormant hair follicle stem cells and induce anagen (growth phase) in telogen (resting phase) hair follicles when binding to hair follicle cell target receptor proteins.


About Androgenetic Alopecia (AGA)


Androgenetic Alopecia (AGA), also called male or female pattern baldness, is the most common hair loss condition affecting both men and women, with a higher incidence in men. While more than half of adult males suffer from AGA, this rate increases to 80% in men at age 50 and above. Male AGA is characterized by receding hairline and baldness on the top and front of the head. Female AGA is usually manifested as hair density thinning on the top and crown of the head. As a degenerative disorder with etiology largely unknown, genetic, psychological and mental, endocrinologic and metabolic factors may play a role. The pathogenesis underlying AGA has been linked to hyperactivation of androgen receptors in hair follicle cells, rendering resting hair follicles unable to re-enter the growth phase and undergoing miniaturization.


About Technoderma Medicines


Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company located in Jiaxing Xiuzhou Biomedicine Guoqian Park, Shanghai. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Lupus Erythematosus and Psoriasis. Its "first-in-class" small molecule drug candidate TDM-105795 for Androgenetic Alopecia is currently undergoing clinical testing. Technoderma’s JAK1/TYK2 inhibitor for Atopic Dermatitis is completing late-stage preclinical testing and it has a target IND filing date in mid-year 2022. The pipeline targets dermatologic indications.

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