- Inclusive study in women and men with androgenetic alopecia to evaluate the safety and preliminary efficacy of PP405, a topical treatment to reactivate dormant hair follicle stem cells
- 14 million USD Funding led by GV (Google Ventures) to accelerate Phase 2 clinical program
- Leading dermatologists join Clinical Advisory Board (CAB) to advance clinical development
LOS ANGELES, 13 August 2024 /PRNewswire/ — Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of hair loss treatments, today 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). The company is enrolling 60 women and men in the clinical trial. PP405 is designed to reactivate dormant hair follicle stem cells to stimulate hair growth.
Pelage also raised a 14 million US dollars Serie A-1, led by GV, after a first 16.75 million US dollars Series A financing announced in February 2024. Series A-1 follows positive Phase 1 data that demonstrated mechanism of action and targeted engagement in patients with androgenetic alopecia and supported a Phase 2 study.
“The advancement of our lead program PP405 into Phase 2a is a pivotal moment in our journey to deliver a noninvasive, innovative treatment for androgenetic alopecia for all genders, skin types and hair types,” said Qing Yu Christina Weng, MD, Chief Medical Officer of Pelage Pharmaceuticals. “We are excited to be able to include women and men of all skin tones and hair textures, which has not always been the case in hair loss studies.”
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.
The Phase 2a study (NCT06393452) is a randomized, placebo-controlled study of PP405 in women and men with androgenetic alopecia. Also known as pattern baldness, it 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.
“GV is encouraged by the results of the previous Phase 1 study and the robust clinical safety profile of Pelage,” said Cathy FriedmanExecutive Venture Partner, GV and Board Member at Pelage Pharmaceuticals. “We believe that Pelage’s team of experts is well positioned to advance this novel and innovative hair loss research and offer a potential alternative to existing treatments that merely slow hair loss.”
Along with the Phase 2a study, 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:
- Matthias AvramMD, JD, FAAD, Director, Massachusetts General Hospital Dermatology Laser & Cosmetic Center and Associate Professor of Dermatology, Harvard University Medical School
- Amelia K. HausauerMD, FAAD, Director of Dermatology and Minimally Invasive Aesthetics at Aesthetx
- Amy McMichaelMD, FAAD, Professor and former Chair of the Department of Dermatology at Wake Forest School of Medicine
- Arash MostaghimiMD, 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 University Medical School
“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,” said Dr. Avram. “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.”
About Pelage Pharmaceuticals
Pelage Pharmaceuticals is a clinical-stage regenerative medicine company developing novel treatments for hair loss, including androgenetic alopecia and chemotherapy-induced alopecia. With a focus on molecular biology and stem cell biology, Pelage is developing a new class of treatments designed to reactivate dormant hair follicle stem cells and restore the body’s ability to naturally grow hair. Its lead program, PP405, is currently in clinical trials. Based on its rigorous scientific foundation, Pelage is pioneering the development of best-in-class hair growth solutions for people of all hair types suffering from hair loss.
About PP405
PP405 is a novel, non-invasive, topical small molecule designed to reactivate dormant hair follicle stem cells and reignite hair growth. Using a regenerative medicine approach, the treatment focuses on the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells. Initial results from a Phase 1 study show that PP405 was well tolerated and demonstrated statistically significant activation of hair follicle stem cells. In 2018, Pelage Pharmaceuticals licensed the intellectual property of PP405 and related topical small molecules from University of California. PP405 is currently in Phase 2a clinical trials to evaluate safety and preliminary efficacy in adults with androgenetic alopecia (NCT06393452).
Don’t miss any more stories from Pelage Pharmaceuticals.
