Comprehensive trial recruiting women and men with androgenetic alopecia to evaluate the safety and preliminary efficacy of PP405, a topical treatment designed to reactivate dormant hair follicle stem cells $14M in funding led by Google Ventures to accelerate Phase 2 clinical program Dermatology leaders join clinical trials Advisory Board (CAB) to advance clinical development
LOS ANGELES , Aug. 13, 2024 /PRNewswire/ — Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today announced that the first patient has been dosed in a Phase 2a clinical trial. Announced. Safety and efficacy of PP405, a novel topical small molecule, in the treatment of androgenetic alopecia (pattern baldness). The company is enrolling 60 men and women in its clinical study. PP405 is designed to reactivate dormant hair follicle stem cells and stimulate hair growth.
Pelage also raised $14 million Series A-led by GV with support from Main Street Advisors, Visionary Ventures, and YK BioVentures, following an initial $16.75 million Series A funding announced in February 2024. We have procured 1. Series A-1 follows a successful Phase 1. This data demonstrates the involvement of mechanisms and targets in patients with androgenetic alopecia and supports the phase 2 study.
“Advancing our lead program PP405 to Phase 2a is a critical step in our journey to provide a non-invasive, innovative treatment for androgenetic alopecia for all genders, skin types and hair types. moment,” said Qing Yu Christina Weg. Doctor of Medicine, Chief Medical Officer, Pelage Pharmaceuticals. “We are excited to include women and men of all skin colors and hair types, something that is not always the case in hair loss research.”
PP405 addresses metabolic processes that regulate hair follicle stem cell activation. In male pattern baldness, a combination of genetics, age, hormones, and environmental factors disrupt the normal hair growth cycle, but the hair 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 trial of PP405 in women and men with androgenetic alopecia. Also known as pattern hair loss, this is the most common form of hair loss and affects most people throughout their lives. Study participants will receive topical application of PP405 or placebo daily. Participants of all skin phototypes, hair types, and textures are welcome. If you are interested in participating, please follow this link for information.
“GV is encouraged by Pelage’s previous Phase 1 data readouts and robust clinical safety profile,” said Cathy Friedman, executive venture partner, GV and director of Pelage Pharmaceuticals. “Pelage’s team of experts believes we are well-positioned to advance this novel and innovative hair loss research and provide a potential alternative to existing treatments that simply delay hair loss. ”
In parallel with the Phase 2a trial, Pelage announced the formation of a Clinical Advisory Board (CAB). The CAB supports the company’s strategic efforts in advancing its clinical programs.
The newly appointed members are:
Matthew Avram, MD, JD, FAAD, Director of the Dermatology Laser and Aesthetics Center at Massachusetts General Hospital and Associate Professor of Dermatology at Harvard Medical School Amelia K. Haushauer, MD, FAAD, Aesthetx Director of Dermatology and Minimally Invasive Aesthetics Amy McMichael, MD, FAAD, Professor and Past Chair of the Department of Dermatology, Wake Forest School of Medicine Arash Mostaghimi, MD, MPA, MPH, FAAD, Associate Professor of Dermatology, Vice Chair for Clinical Trials and Innovation, Director of Dermatology Inpatient Services, Brigham University & Women’s Hospital/Harvard 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 clinical practice,” said Abram. said the doctor. “Hair loss affects an incredibly diverse patient population and this should be reflected in early clinical trials. We hope that participants will reflect the diversity of those affected by hair loss. We focus on guiding research design to support participation.”
About Pelage Pharmaceuticals
Pelage Pharmaceuticals is a clinical-stage regenerative medicine company developing new treatments for hair loss, including androgenetic alopecia and chemotherapy-induced alopecia. Focused on molecular biology and stem cell biology, Pelage advances a new class of treatments designed to reactivate dormant hair follicle stem cells and restore the body’s ability to grow hair naturally. I’m doing it. Its lead program, PP405, is currently in clinical trials. Through rigorous scientific evidence, Pelage is pioneering a first-in-class hair growth solution for people of all hair types experiencing hair loss.
About PP405
PP405 is a novel, non-invasive, topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth. This treatment focuses on addressing the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells through a regenerative medicine approach. Early results from a Phase 1 study indicate that PP405 was well tolerated and demonstrated statistically significant activation of hair follicle stem cells. In 2018, Pelage Pharmaceuticals licensed intellectual property for PP405 and related topical small molecules from the University of California. PP405 is currently in Phase 2a clinical evaluation to evaluate safety and preliminary efficacy in adults with androgenetic alopecia (NCT06393452).
Source: Pelage Pharmaceuticals
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