Regenerative Hair Loss Treatment Targets Dormant Follicle Stem Cells [Clinical Trial]

Overhead shot of dropper vitamin application on bald scalp, isolated on a clean background, well-lit studio setting, emphasizing effective hair care
Pelage Pharmaceuticals announced the commencement of the Phase 2a trial for PP405, a novel hair loss treatment targeting dormant follicle stem cells.
Image by Alpha at Adobe Stock

Pelage Pharmaceuticals, a clinical-stage regenerative medicine company, has initiated its Phase 2a trial for PP405, a topical small molecule designed to treat androgenetic alopecia. The study will evaluate safety and efficacy in 60 diverse participants, including both women and men. The company has secured $14 million in Series A-1 financing, led by GV, following positive Phase 1 results. This funding will accelerate the clinical program for this innovative hair loss treatment.

Dr. Qing Yu Christina Weng, Chief Medical Officer at Pelage, emphasized the inclusivity of the trial, stating, "We are committed to developing a non-invasive treatment for androgenetic alopecia that serves all genders, skin types, and hair textures."

PP405 Clinical Trial

PP405 targets the metabolic processes regulating hair follicle stem cell activation. It aims to reactivate dormant processes and restore the hair growth cycle in androgenetic alopecia, where follicles and stem cells remain intact despite disrupted growth cycles. Phase 1 results showed PP405 was well-tolerated with significant stem cell activation.

Currently in Phase 2a clinical evaluation (NCT06393452), PP405 assesses safety and efficacy in adults with androgenetic alopecia. The Phase 2a trial (NCT06393452) is a randomized, placebo-controlled study open to participants of all skin phototypes and hair types. Interested individuals can find information at the provided link. Cathy Friedman, Executive Venture Partner at GV and Pelage Board Director, expressed confidence in the potential of PP405 as an alternative to existing hair loss treatments.

Renowned Dermatology Experts to Guide Clinical Programs 

Pelage has also formed a Clinical Advisory Board comprising renowned dermatology experts to guide its clinical programs. The board includes Drs. Mathew Avram, Amelia K. Hausauer, Amy McMichael and Arash Mostaghimi. Dr. Avram highlighted the importance of diverse representation in clinical trials, stating, "We're focused on guiding the study design to support the inclusion of participants that reflect the diversity of people affected by hair loss."

This Phase 2a trial marks a significant step in Pelage's mission to develop innovative, inclusive solutions for hair loss, potentially offering new hope to the diverse population affected by androgenetic alopecia.

Reference

  1. Pelage Pharmaceuticals advances clinical program with first patients dosed in phase 2 study for hair loss and GV-led $14M series A-1. News release. August 13, 2024. Accessed August 15, 2024. 
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