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皮肤美容处方产品开发商Eirion Therapeutics宣布启动首次人体临床试验,评估外用ET-02治疗雄激素性脱发的效果

Eirion Therapeutics Announces Initiation of First-in-Human Clinical Trial Evaluating Topical ET-02 for the Treatment of Androgenic Alopecia

BioSpace 等信源发布 2024-07-04 14:56

可切换为仅中文


WOBURN, Mass., July 1, 2024 /PRNewswire/ -- Eirion Therapeutics Inc. announced today that the first participant has been enrolled in a Phase 1 clinical trial to evaluate the safety of the patented topical pharmaceutical ET-02 for the treatment of androgenic alopecia (age-related hair loss). This double-blind, placebo-controlled study is designed to determine the safety of ET-02 for once daily treatment over 28 days.

马萨诸塞州沃本,2024年7月1日/PRNewswire/-Eirion Therapeutics Inc.今天宣布,第一位参与者已参加第一阶段临床试验,以评估专利外用药物ET-02治疗雄激素性脱发(年龄相关性脱发)的安全性。这项双盲安慰剂对照研究旨在确定ET-02在28天内每天一次治疗的安全性。

The study is expected to recruit approximately 24 subjects at three investigation centers in the United States..

该研究预计将在美国的三个调查中心招募大约24名受试者。。

ET-02 has a novel mechanism of action which targets returning hair follicle stem cells that have become defective and / or inactive in men suffering from age-related hair loss to normal activity and function. Hair follicle stem cells are known to be the 'master control switches' for hair growth. By returning stem cells to normal activity and function, the expectation is that hair can be grown normally again.

ET-02具有一种新的作用机制,其靶向使患有年龄相关性脱发的男性的毛囊干细胞恢复正常活动和功能。毛囊干细胞是毛发生长的“主控开关”。通过使干细胞恢复正常的活性和功能,人们期望头发可以再次正常生长。

Because ET-02 directly addresses what the Company believes is the fundamental cause of androgenic alopecia, the Company expects this new treatment has the potential to be significantly more effective than existing treatments which have no known direct impact on hair follicle stem cells..

由于ET-02直接解决了该公司认为是雄激素性脱发的根本原因,因此该公司预计这种新疗法有可能比对毛囊干细胞没有直接影响的现有疗法更有效。。

'Given its postulated mechanism of action, ET-02 represents a potentially substantial advancement over commercially available pharmaceuticals for the treatment of androgenic alopecia,' said Jerry Shapiro, MD, a leading expert on the treatment of hair loss and Professor of Dermatology at New York University Grossman School of Medicine.

纽约大学格罗斯曼医学院(New York University Grossman School of Medicine)脱发治疗领域的领先专家、皮肤病学教授杰里·夏皮罗(Jerry Shapiro)医学博士说:“鉴于其假定的作用机制,ET-02代表了比市售药物治疗雄激素性脱发的潜在实质性进步。”。

'This Phase 1 safety study is an important first step in evaluating ET-02. Assuming all goes well, this study will lead to a Phase 2 study evaluating ET-02's efficacy.'.

“这项第一阶段安全性研究是评估ET-02的重要第一步。假设一切顺利,这项研究将导致一项评估ET-02疗效的2期研究。”。

Jon Edelson, MD, CEO and President of Eirion, added, 'A controlled pre-clinical study of ET-02 treating 90 human scalp tissue grafts from men who have intermediate-stage androgenic alopecia demonstrates this pharmaceutical's potential to restore hair growth and return hair follicles to normal structure and function.

Eirion首席执行官兼总裁Jon Edelson医学博士补充道,“ET-02治疗90例中期雄激素性脱发男性头皮组织移植物的临床前对照研究表明,该药物具有恢复头发生长和毛囊恢复正常结构和功能的潜力。

Because of ET-02's unique mechanism of action, we believe that ET-02 has the potential to not only treat androgenic alopecia but prevent it.'.

由于ET-02具有独特的作用机制,我们认为ET-02不仅具有治疗雄激素性脱发的潜力,而且具有预防雄激素性脱发的潜力。

Unlike some other commercially available treatments, ET-02 does not target hormonal pathways and is not expected to have the side effects associated with such treatments, which include sexual dysfunction.

与其他一些商业上可用的治疗方法不同,ET-02不靶向激素途径,预计不会产生与此类治疗相关的副作用,包括性功能障碍。

The Company believes that ET-02 also has the potential to treat and prevent hair greying by impacting the stem cell that controls hair color which is called the melanocyte stem cell. The Company plans to pursue treatment of this indication in the future. ET-02 is the third product currently in development by Eirion.

该公司认为,ET-02还具有通过影响控制头发颜色的干细胞(称为黑素细胞干细胞)来治疗和预防头发变白的潜力。该公司计划在未来继续治疗这种适应症。ET-02是Eirion目前正在开发的第三种产品。

ET-01 topical neuromodulator is in Phase 2 and has been studied in clinical trials with over 750 subjects in aggregate. AI-09 next-generation, ready-to-use liquid injectable neuromodulator has been studied in 96 subjects in a Phase 1 - 2 clinical trial. .

ET-01局部神经调节剂处于第二阶段,已经在总共750多名受试者的临床试验中进行了研究。AI-09下一代即用液体注射神经调节剂已在96名受试者的1-2期临床试验中进行了研究。。

'ET-02 is a highly complementary product to our two other aesthetic bio-pharmaceutical products in development, which are both potential treatments for facial wrinkles. Taking these three product candidates together, Eirion has built an exciting and robust pipeline for aesthetic medicine innovation,' commented Dr.

“ET-02是我们正在开发的另外两种美学生物制药产品的高度补充产品,这两种产品都是面部皱纹的潜在治疗方法。艾利昂博士评论道,将这三种候选产品结合在一起,为美容医学创新建立了一条令人兴奋且强大的渠道。

Edelson.   .

埃德森。。

About Eirion Therapeutics, Inc.

关于Eirion Therapeutics,Inc。

Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying.

Eirion Therapeutics,Inc.是一家私营的临床阶段生物制药公司,正在开发下一代美容皮肤病处方产品。艾利昂目前拥有丰富的产品线,专注于治疗皱纹,原发性腋下多汗症,雄激素性脱发和头发变白。

In the future, Eirion plans to pursue additional indications that address other major unmet clinical needs for physicians and their patients. .

未来,埃利昂计划寻求其他适应症,以解决医生及其患者的其他主要未满足的临床需求。。