Pelage Pharmaceuticals, a pioneering company in regenerative medicine, has announced significant progress in its quest to develop innovative treatments for hair loss. The company has commenced dosing the first patients in its Phase 2a clinical trial for PP405, a novel topical treatment designed to reactivate dormant hair follicle stem cells. This trial aims to evaluate the safety and preliminary efficacy of PP405 in treating androgenetic alopecia, commonly known as pattern baldness. The study is inclusive, recruiting 60 women and men of various skin tones and hair textures, a notable step towards addressing the diverse population affected by hair loss.

The Phase 2a trial (NCT06393452) is a randomized, placebo-controlled study where participants will receive a daily topical application of either PP405 or a placebo. This trial follows promising Phase 1 data that demonstrated proof of mechanism and target engagement, supporting the advancement to Phase 2. "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 Dr. Qing Yu Christina Weng, Chief Medical Officer of Pelage Pharmaceuticals.

$14M Series A-1 Funding Led by GV

In addition to the clinical trial progress, Pelage Pharmaceuticals has successfully raised $14 million in Series A-1 funding, led by GV (formerly Google Ventures). This funding round follows an initial $16.75 million Series A financing announced in February 2024. The new capital will be used to accelerate the Phase 2 clinical program and further the development of PP405.

Cathy Friedman, Executive Venture Partner at GV and Board Director at Pelage Pharmaceuticals, expressed confidence in the company's potential. "GV is encouraged by Pelage’s prior Phase 1 data readouts and robust clinical safety profile. 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," she said.

Pelage Pharmaceuticals licensed the intellectual property for PP405 and related topical small molecules from the University of California in 2018. The company’s focus on molecular and stem cell biology has positioned it as a leader in developing first-in-class hair growth solutions.

Formation of Clinical Advisory Board

To support its strategic initiatives and advance its clinical programs, Pelage Pharmaceuticals has established a Clinical Advisory Board (CAB) comprising leading experts in dermatology. The newly appointed members include:

Dr. Mathew Avram, Director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center and Associate Professor of Dermatology at Harvard Medical School

Dr. Amelia K. Hausauer, Director of Dermatology and Minimally Invasive Aesthetics at Aesthetx

Dr. Amy McMichael, Professor and past Chair of the Department of Dermatology at Wake Forest School of Medicine

Dr. Arash Mostaghimi, Associate Professor of Dermatology, Vice Chair of Clinical Trials and Innovation, and Director of the Dermatology Inpatient Service at Brigham & Women’s Hospital/Harvard Medical School

Dr. Avram highlighted the importance of diversity in clinical trials, noting that hair loss impacts a wide range of people. "The compelling science behind Pelage’s approach signals an exciting opportunity to potentially reverse the effects of alopecia, an issue I see daily in my clinical practice. We’re focused on guiding the study design to support the inclusion of participants that reflect the diversity of people affected by hair loss," he said.

About Pelage Pharmaceuticals

Credit:Pelage Pharmaceuticals

Pelage Pharmaceuticals is a clinical-stage regenerative medicine company dedicated to developing novel treatments for hair loss, including androgenetic alopecia and chemotherapy-induced alopecia. The company’s lead program, PP405, is a non-invasive topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth. Early results from a Phase 1 trial showed that PP405 was well-tolerated and demonstrated statistically significant activation of hair follicle stem cells.

Pelage’s approach focuses on addressing the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells. By leveraging molecular and stem cell biology, Pelage aims to restore the body’s natural ability to grow hair, offering hope to millions of people affected by hair loss worldwide.

For more information about the Phase 2 trial and participation details, visit the clinical trial registry (NCT06393452).

SOURCE Pelage Pharmaceuticals