Pelage Pharmaceuticals, a clinical-stage regenerative medicine company crearting a new generation of treatments for hair loss, 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). 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.
For the Phase 2a clinical trial, the company is enrolling 60 women and men for the clinical study. PP405 was designed to reactivate dormant hair follicle stem cells to stimulate hair growth. The Series A-1 funding round follows positive Phase 1 data, which showed proof of mechanism and target engagement in patients with androgenetic alopecia, supporting a Phase 2 study.
PP405 addresses the metabolic processes that regulate activation of hair follicle stem cells. And 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.
This Phase 2a trial (NCT06393452) is a randomized, placebo-controlled study of PP405 in women and men with androgenetic alopecia. Known as pattern balding, it is the most common form of alopecia and will affect most people throughout their lives. The study participants will receive a daily topical application of PP405 or a placebo. Participants of all skin phototypes and hair types and textures are eligible. Those interested in participating can find the information at this link.
Along with the Phase 2a trial, Pelage announced the formation of its Clinical Advisory Board (CAB), which will support the company’s strategic initiatives as it advances its clinical programs.
The newly appointed members are:
– Mathew Avram, M.D., J.D., F.A.A.D., Director, Massachusetts General Hospital Dermatology Laser & Cosmetic Center and Associate Professor of Dermatology, Harvard Medical School
– Amelia K. Hausauer, M.D., F.A.A.D., Director of Dermatology and Minimally Invasive Aesthetics at Aesthetx
– Amy McMichael, M.D., F.A.A.D., Professor and past Chair, Department of Dermatology at Wake Forest School of Medicine
– Arash Mostaghimi, M.D., M.P.A., M.P.H., F.A.A.D., 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
KEY QUOTES:
“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. 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.”
– Qing Yu Christina Weng, M.D., Chief Medical Officer, Pelage Pharmaceuticals
“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.”
– Cathy Friedman, Executive Venture Partner, GV and Board Director, Pelage Pharmaceuticals
“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. Hair loss impacts an incredibly diverse patient population, which should be reflected in early clinical trials. We’re focused on guiding the study design to support the inclusion of participants that reflect the diversity of people affected by hair loss.”
– Dr. Avram
