Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing a new generation of hair loss treatments, announced that the first patients have been treated 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 closed a $14 million Series A-1 financing 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.
The company is enrolling 60 women and men for the Phase 2a clinical trial. PP405 is designed to reactivate dormant hair follicle stem cells to stimulate hair growth. The Series A-1 funding round follows positive Phase 1 data that demonstrated mechanism of action and target engagement in patients with androgenetic alopecia and supported a Phase 2 study.
PP405 addresses the metabolic processes that regulate the activation of hair follicle stem cells. In androgenetic alopecia, the normal hair growth cycle is disrupted due to a combination of genetic factors, 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 hair growth cycle.
This Phase 2a study (NCT06393452) is a randomized, placebo-controlled study of PP405 in women and men with androgenetic alopecia. This form of alopecia, known as pattern baldness, is the most common form of alopecia and affects most people throughout their lives. Study participants will receive a daily topical application of PP405 or a placebo. Participants of all skin types and hair types and textures are eligible. Interested parties 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 in advancing its clinical programs.
The newly appointed members are:
– Mathew Avram, MD, JD, FAAD, Director, Massachusetts General Hospital Dermatology Laser & Cosmetic Center and Associate Professor of Dermatology, Harvard Medical School
– Amelia K. Hausauer, MD, FAAD, Director of Dermatology and Minimally Invasive Aesthetics at Aesthetx
– Amy McMichael, MD, FAAD, professor and former head of the Department of Dermatology at Wake Forest School of Medicine
– Arash Mostaghimi, MD, MPA, MPH, FAAD, 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 provide a non-invasive, innovative treatment for androgenetic alopecia for 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, MD, Chief Medical Officer, Pelage Pharmaceuticals
“GV is encouraged by Pelage’s Phase 1 data to date and robust clinical safety profile. We believe Pelage’s team of experts is well positioned to advance this novel and innovative hair loss research and provide a potential alternative to existing treatments that merely slow hair loss.”
– Cathy Friedman, Executive Venture Partner, CEO and Board Member, Pelage Pharmaceuticals
“The compelling science behind Pelage’s approach suggests an exciting opportunity to potentially reverse the effects of alopecia, a problem I see every day in my clinical practice. Hair loss affects an incredibly diverse patient population, which should be reflected in early clinical trials. We are focused on shaping the study design to support the inclusion of participants who reflect the diversity of people affected by hair loss.”
– Dr. Avram
