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再生医学技术研究商Pelage Pharmaceuticals治疗雄激素性脱发PP405 2a期临床试验首批患者给药

Pelage Pharmaceuticals Advances Clinical Program with First Patients Dosed in Phase 2 Study for Hair Loss and GV-Led $14M Series A-1

vcaonline 等信源发布 2024-08-19 11:04

可切换为仅中文


Leaders in dermatology join Clinical Advisory Board (CAB) to advance clinical developmentLOS ANGELES, August 13, 2024-- Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today announced that the first patients have been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of PP405, a novel topical small molecule, for the treatment of androgenetic alopecia (pattern baldness).

皮肤科的领导者加入临床咨询委员会(CAB)推动临床发展2024年8月13日,洛杉矶——开创新一代脱发治疗方法的临床阶段再生医学公司Pelage Pharmaceuticals今天宣布,首批患者已在其2a期临床试验中服用药物,评估新型局部小分子PP405治疗雄激素性脱发(模式秃发)的安全性和有效性。

The company is enrolling 60 women and men for the clinical study. PP405 is designed to reactivate dormant hair follicle stem cells to stimulate hair growth..

该公司正在招募60名女性和男性进行临床研究。PP405旨在重新激活休眠的毛囊干细胞以刺激头发生长。。

Pelage also raised a $14 million Series A-1, led by GV with support from Main Street Advisors, Visionary Ventures, and YK BioVentures, following an initial $16.75 million Series A financing announced in February 2024. The Series A-1 follows positive Phase 1 data, which demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia, supporting a Phase 2 study..

佩拉奇还筹集了1400万美元的a-1系列融资,由GV牵头,并得到了Main Street Advisors、Visionary Ventures和YK BioVentures的支持,此前于2024年2月宣布了1675万美元的a系列融资。A-1系列遵循积极的1期数据,该数据证明了雄激素性脱发患者的机制和目标参与的证据,支持了2期研究。。

'The advancement of our lead program, PP405, into Phase 2a is a pivotal moment in our journey to deliver a non-invasive, innovative treatment for androgenetic alopecia across all genders, skin types, and hair types,' said Qing Yu Christina Weng, M.D., Chief Medical Officer, Pelage Pharmaceuticals. 'We are excited to include women and men of all skin tones and hair textures, which has not always been the case in hair loss studies.'.

Pelage Pharmaceuticals首席医疗官、医学博士青玉克里斯蒂娜·翁(QingYu ChristinaWeng)说:“我们的领先项目PP405进入2a期是我们为所有性别、皮肤类型和头发类型的雄激素性脱发提供无创创新治疗之旅的关键时刻。”我们很高兴能包括所有肤色和头发质地的女性和男性,这在脱发研究中并不总是如此。”。

PP405 addresses the metabolic processes that regulate activation of hair follicle stem cells. In androgenetic alopecia, the normal growth cycle of hair is disrupted due to a combination of genetics, age, hormones, and environmental factors, but the follicles and stem cells remain intact. PP405 is based on the discovery of a molecular switch that specifically targets hair follicle stem cells to reactivate dormant processes and restore the growth cycle of hair..

PP405解决了调节毛囊干细胞活化的代谢过程。在雄激素性脱发中,由于遗传,年龄,激素和环境因素的综合作用,头发的正常生长周期被破坏,但卵泡和干细胞保持完整。PP405基于一种分子开关的发现,该开关专门针对毛囊干细胞,以重新激活休眠过程并恢复头发的生长周期。。

The Phase 2a trial (NCT06393452) is a randomized, placebo-controlled study of PP405 in women and men with androgenetic alopecia. Also known as pattern balding, it is the most common form of alopecia and will affect most people throughout their lives. Study participants will receive a daily topical application of PP405 or a placebo.

2a期试验(NCT06393452)是一项针对男性和女性雄激素性脱发患者PP405的随机安慰剂对照研究。也被称为斑秃,它是最常见的脱发形式,会影响大多数人的一生。研究参与者将每天局部应用PP405或安慰剂。

Participants of all skin phototypes and hair types and textures are eligible. Those interested in participating can find the information at this link..

所有皮肤照片类型和头发类型和纹理的参与者都符合条件。有兴趣参与的人可以在这个链接上找到信息。。

'GV is encouraged by Pelage's prior Phase 1 data readouts and robust clinical safety profile,' said Cathy Friedman, Executive Venture Partner, GV and Board Director, Pelage Pharmaceuticals. 'We believe the expert team at Pelage is well-positioned to advance this novel and innovative hair loss research, providing a potential alternative to existing treatments that simply slow hair loss.'.

佩拉奇制药公司(Pelage Pharmaceuticals)执行风险合伙人、董事会董事凯西·弗里德曼(CathyFriedman)说,佩拉奇之前的第一阶段数据读数和强大的临床安全性让GV感到鼓舞我们相信,佩拉奇的专家团队能够很好地推进这项新颖而创新的脱发研究,为现有的减缓脱发的治疗方法提供潜在的替代方案。”。

Along with the Phase 2a trial, Pelage has announced the formation of its Clinical Advisory Board (CAB), which will support the company's strategic initiatives as it advances its clinical programs.

随着2a期临床试验的进行,Pelage宣布成立临床咨询委员会(CAB),该委员会将在推进临床项目的同时支持公司的战略举措。

About Pelage Pharmaceuticals

关于Pelage Pharmaceuticals

Pelage Pharmaceuticals is a clinical-stage regenerative medicine company developing novel treatments for hair loss including androgenetic alopecia and chemotherapy-induced-alopecia. With a focus on molecular and stem cell biology, Pelage is advancing a new class of treatments designed to reactivate dormant hair follicle stem cells and restore the body's ability to naturally grow hair.

Pelage Pharmaceuticals是一家临床阶段再生医学公司,开发用于脱发的新型治疗方法,包括雄激素性脱发和化疗引起的脱发。Pelage专注于分子和干细胞生物学,正在推进一类新的治疗方法,旨在重新激活休眠的毛囊干细胞,恢复身体自然生长头发的能力。

Its lead program, PP405, is currently in clinical trials. Through its rigorous scientific foundation, Pelage is pioneering first-in-class hair growth solutions for people of all hair types experiencing hair loss..

其领先项目PP405目前正在进行临床试验。通过其严格的科学基础,Pelage是一流的头发生长解决方案的先驱,适用于经历脱发的所有头发类型的人。。

About PP405

关于PP405

PP405 is a novel, non-invasive, topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth. Through a regenerative medicine approach, the treatment focuses on addressing the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells.

PP405是一种新型的非侵入性局部小分子,旨在重新激活休眠的毛囊干细胞并重新启动毛发生长。通过再生医学方法,治疗重点是解决调节毛囊干细胞活化和失活阶段的代谢过程。

Early results from a Phase 1 trial show that PP405 was well-tolerated and demonstrated statistically significant activation of hair follicle stem cells. In 2018, Pelage Pharmaceuticals licensed the intellectual property to PP405 and related topical small molecules from the University of California. PP405 is currently in Phase 2a clinical evaluation to assess safety and preliminary efficacy in adults with androgenetic alopecia (NCT06393452)..

第一阶段试验的早期结果表明,PP405耐受性良好,并显示出毛囊干细胞的统计学显着活化。2018年,Pelage Pharmaceuticals将知识产权许可给加利福尼亚大学的PP405和相关的局部小分子。PP405目前正在进行2a期临床评估,以评估雄激素性脱发成人的安全性和初步疗效(NCT06393452)。。