Pelage Pharmaceuticals Reports Positive Phase 2a Trial Results for PP405 in Hair Loss Therapy

Pelage Pharmaceuticals, a key player in regenerative medicine, has announced promising outcomes from a Phase 2a clinical trial concerning their innovative topical treatment, PP405, designed for androgenetic alopecia. Notably, PP405, progressing through the FDA clinical development process, offers a potentially new approach to hair loss treatment for both men and women by reactivating dormant hair follicle stem cells.

Hair loss is a widespread issue affecting over 80% of men and 40% of women throughout their lives. Despite the prevalence, effective treatments remain sparse. The global market for hair loss prevention products was valued at $23.6 billion in 2021, with anticipated growth to $31.5 billion by 2028. PP405 addresses this significant demand through a unique regenerative topical therapy that diverges from existing treatments primarily targeting secondary causes, such as hormonal imbalances. Instead, PP405 intervenes in the primary biological pathways that control the natural hair follicle cycle, making it a potentially suitable option for a broader range of patients, including women and those with chronic hair loss.

In the Phase 2a trial, 78 individuals with androgenetic alopecia, representing diverse skin types and hair textures, participated. Participants applied either PP405 or a placebo daily on their scalps for four weeks and were monitored for a total of 12 weeks. The study successfully achieved its primary safety endpoint, with no systemic absorption of PP405 detected in the blood, indicating a strong safety profile. There were also exploratory endpoints that assessed initial signs of new hair growth.

Preliminary findings revealed a rapid and statistically significant clinical response. Remarkably, four weeks post-treatment, 31% of men with a higher degree of hair loss treated with PP405 experienced over 20% increase in hair density, while no such change was observed in the placebo group. Typically, visible hair regrowth requires extended treatment periods of 6-12 months. However, PP405 appears to prompt a quicker clinical response. Uniquely, PP405 induced new hair growth from previously inactive follicles, suggesting its significant regenerative capability.

Research indicates that in pattern hair loss patients, dormant hair follicles and stem cells remain in bald areas, rendered inactive by various factors, including aging and environmental aspects. By activating these inactive follicular stem cells, PP405 holds promise for hair regrowth in thinning or bald regions, distinguishing itself in a market dominated by maintenance-focused solutions.

Dr. Christina Weng, Chief Medical Officer of Pelage Pharmaceuticals, emphasized the significance of these findings in advancing regenerative medicine. The company is committed to delivering a scientifically sound solution for all, as they progress into the next developmental phase.

Pelage’s approach aligns with the FDA regulatory pathway, emphasizing their dedication to rigorous science and patient safety. Following the randomized controlled part of the study, participants initially given a placebo could join a three-month open-label safety extension to assess long-term safety. The company anticipates launching Phase 3 studies in 2026 to further examine PP405’s safety and efficacy in both men and women.

Dr. Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation at Brigham and Women’s Hospital, highlighted the rarity of such early measurable biological activity in a topically delivered therapy like PP405, which could redefine clinical progress in hair growth.

Pelage Pharmaceuticals’ technological advancements are based on pioneering stem cell research from UCLA, supported by a team of experts in dermatology and regenerative biology and backed by renowned investors including GV (Google Ventures). The company is dedicated to creating first-in-class hair growth solutions for individuals experiencing hair loss across all hair types.