Pelage Pharmaceuticals Advances Clinical Program with First Patients Dosed in Phase 2 Study for Hair Loss and GV-Led $14M Series A-1

News provided by

Aug 13, 2024, 08:00 ET

Inclusive trial recruiting women and men with androgenetic alopecia to evaluate safety and preliminary efficacy of PP405, a topical treatment designed to reactivate dormant hair follicle stem cells
$14M financing led by GV (Google Ventures) to accelerate Phase 2 clinical program
Leaders in dermatology join Clinical 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 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). The company is enrolling 60 women and men for the clinical study. PP405 is designed to reactivate dormant hair follicle stem cells to stimulate hair growth.

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. The Series A-1 follows positive Phase 1 data, which demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia, supporting a Phase 2 study.

"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," said Qing Yu Christina Weng, M.D., Chief Medical Officer, Pelage Pharmaceuticals. "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."

PP405 addresses the metabolic processes that regulate activation of hair follicle stem cells. 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.

The Phase 2a trial (NCT 06393452) is a randomized, placebo-controlled study of PP405 in women and men with androgenetic alopecia. Also known as pattern balding, it is the most common form of alopecia and will affect most people throughout their lives. 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.

"GV is encouraged by Pelage's prior Phase 1 data readouts and robust clinical safety profile," said Cathy Friedman, Executive Venture Partner, GV and Board Director, Pelage Pharmaceuticals. "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."

Along with the Phase 2a trial, Pelage has 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

"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," said Dr. Avram. "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."

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 and stem cell biology, Pelage is advancing 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. Through its rigorous scientific foundation, Pelage is pioneering first-in-class hair growth solutions 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. Through a regenerative medicine approach, the treatment focuses on addressing the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells. Early results from a Phase 1 trial show that PP405 was well-tolerated and demonstrated statistically significant activation of hair follicle stem cells. In 2018, Pelage Pharmaceuticals licensed the intellectual property to PP405 and related topical small molecules from the University of California. PP405 is currently in Phase 2a clinical evaluation to assess safety and preliminary efficacy in adults with androgenetic alopecia (NCT 06393452).

SOURCE Pelage Pharmaceuticals