LOS ANGELES, March 9, 2024 /PRNewswire/ -- Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today presented positive translational and Phase 1 clinical data demonstrating the company's novel small molecule therapy PP405 reactivates dormant hair follicle stem cells to trigger hair growth.

洛杉矶，2024年3月9日/PRNewswire/--Pelage Pharmaceuticals是一家开创新一代脱发治疗方法的临床阶段再生医学公司，今天提供了积极的转化和1期临床数据，证明该公司的新型小分子疗法PP405重新激活休眠的毛囊干细胞以触发毛发生长。

Data were presented in a late-breaking oral session of the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, titled Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo..

数据在圣地亚哥举行的美国皮肤病学会（AAD）2024年会上发表，该年会的主题是抑制丙酮酸氧化激活体外人毛囊干细胞。

'The translational data derived from our ex vivo studies on human facelift skin have been further validated in a Phase 1 first-in-human clinical trial demonstrating PP405 effectively reactivates dormant hair follicle stem cells,' said Daniel Gil, Ph.D., CEO of Pelage Pharmaceuticals. 'This therapy represents an exciting new option for not only treating but reversing hair loss.

Pelage Pharmaceuticals首席执行官丹尼尔·吉尔（DanielGil）博士说：“我们对人类整容皮肤进行的离体研究得出的转化数据已在第一阶段人体临床试验中得到进一步验证，证明PP405能有效激活休眠的毛囊干细胞。”这种疗法代表了一种令人兴奋的新选择，不仅可以治疗脱发，还可以逆转脱发。

We look forward to advancing PP405 to Phase 2 clinical studies this year.'.

我们期待着今年将PP405推进到2期临床研究。”

PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH), which stem cells are particularly sensitive to, resulting in their activation and hair growth.

PP405是一种有效的局部线粒体丙酮酸载体（MPC）抑制剂，其作用于细胞代谢途径以上调乳酸脱氢酶（LDH），干细胞对其特别敏感，导致其活化和毛发生长。

Data presented at AAD showed in human facelift skin, single topical applications of 0.006% and 0.06% PP405 led to an increase in LDH activity in hair follicle stem cells within 24 hours. The LDH activity corresponded with a significant increase in Ki67 signal in the hair bulge, indicating a proliferative response of the hair follicle stem cells.

AAD提供的数据显示，在人类整容皮肤中，单次局部应用0.006%和0.06%PP405导致毛囊干细胞中LDH活性在24小时内增加。LDH活性与毛发凸起中Ki67信号的显着增加相对应，表明毛囊干细胞的增殖反应。

The findings demonstrated proof of mechanism in human explanted skin consistent with the results in animal models..

这些发现证明了人类移植皮肤的机制证明与动物模型的结果一致。

The data informed Pelage's Phase 1 clinical trial that concluded in January 2024, which demonstrated that PP405 was safe and well-tolerated, with the target pharmacokinetic profile achieved. Additionally, the Phase 1 study demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia.

该数据为Pelage于2024年1月结束的1期临床试验提供了信息，该试验表明PP405安全且耐受性良好，达到了目标药代动力学特征。此外，第一阶段研究证明了雄激素性脱发患者的机制和目标参与的证据。

There was a statistically significant increase in the Ki67 signal compared to baseline after just seven days of 0.05% PP405 topical treatment. Evidence of newly emerging hair germs – the hallmark of the telogen to anagen transition - was also observed. The topical molecule also received positive formulation reviews from patients..

仅在0.05%PP405局部治疗7天后，与基线相比，Ki67信号有统计学显着增加。还观察到了新出现的毛细菌的证据，这是休止期向生长期过渡的标志。局部分子也收到了患者的积极配方评论。

'We are incredibly excited about this data, and PP405 offers an opportunity to change the landscape of alopecia treatment through directly targeting hair follicle stem cells at the source through a clear mechanistic pathway,' said Qing Yu Christina Weng, M.D., CMO of Pelage Pharmaceuticals. 'The Phase 1b study of PP405 demonstrates a strong safety profile, confirms daily topical dosing with no detectable drug levels in the blood, and demonstrates proof of mechanism with statistically significant activation of hair follicle stem cells.

Pelage Pharmaceuticals首席执行官、医学博士青玉·克里斯蒂娜·翁（QingYu ChristinaWeng）说：“我们对这些数据感到无比兴奋，PP405为改变脱发治疗格局提供了一个机会，通过一种明确的机制途径，从源头上直接靶向毛囊干细胞。”PP405的1b期研究显示出很强的安全性，证实了每日局部给药，血液中没有可检测到的药物水平，并证明了毛囊干细胞具有统计学显着活化的机制。

We can also see the structural architecture of the follicle on biopsy moving through the hair cycle from resting to growing as the stem cells become activated.' .

我们还可以在活检中看到毛囊的结构结构，随着干细胞的激活，毛囊在毛发周期中从静止到生长。

Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024, recruiting both men and women with androgenetic alopecia. PP405 may also have applications for other forms of alopecia, including telogen effluvium (stress-induced hair loss) and chemotherapy-induced hair loss.

Pelage将于2024年年中开始PP405的多中心2a期试验，招募患有雄激素性脱发的男性和女性。PP405还可以用于其他形式的脱发，包括休止期臭气（压力引起的脱发）和化疗引起的脱发。

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, topical formulation, and novel mechanism of action, 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，局部配方和新颖的作用机制，Pelage是一流的头发生长解决方案，适用于所有脱发类型的人。

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 UCLA Technology Development Group..

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将知识产权授予了加州大学洛杉矶分校技术开发小组的PP405和相关的局部小分子。