- Pioneers novel approach to restore the body’s natural ability to grow hair by reactivating dormant hair follicle stem cells
- Phase I clinical data meets primary safety endpoints and shows statistically significant stem cell activation in hair follicles after one week of treatment with PP405; Phase 2 clinical trial to begin in mid-2024
- Announces the appointment of Qing Yu Christina Weng, M.D., as Chief Medical Officer
LOS ANGELES — Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, announced today that the company has closed a $16.75 million Series A financing led by GV with participation from Main Street Advisors, Visionary Ventures and YK BioVentures, to advance a first-in-class treatment for androgenetic alopecia or pattern baldness, and other types of alopecia including chemotherapy-induced hair loss.
“Our scientific co-founders have uncovered a unique biological mechanism with the potential to reactivate hair growth in people with alopecia,” said Daniel Gil, Ph.D., Chief Executive Officer, Pelage Pharmaceuticals. “We are pleased to announce that we have completed a first-in-human Phase 1 clinical trial that demonstrated seven days of topical dosing with PP405 was safe and well-tolerated, and showed statistically significant activation of hair follicle stem cells. With the support of GV, Main Street Advisors and other top-tier investors, we expect to advance our lead program to a Phase 2a clinical trial in the second half of this year.”
The Phase 1 trial evaluating PP405, a novel topical agent designed to treat androgenetic alopecia and other forms of hair loss, showed 0.05% PP405 topical treatment for seven days is safe and tolerable with no adverse events, and provided confirmation of a daily dosing regimen. Importantly, the study demonstrated biological activity, proof of mechanism of action seen in preclinical studies, and showed treatment with PP405 stimulated statistically significant activation of a critical hair follicle stem cell activation marker. Translational data will be presented at the American Academy of Dermatology meeting in March.
Androgenetic alopecia, also known as pattern balding, is the most common form of alopecia and accounts for more than 90% of all hair loss, impacting both men and women. Additionally, PP405 may also have applications for other types of hair loss such as telogen effluvium (stress-induced hair loss) and chemotherapy-induced hair loss.
“What we’ve observed is that in people who experience hair loss, the actual hair follicle stem cells are still present but have reverted to a dormant state. We have uncovered a small molecule able to stimulate cellular metabolism to re-awaken hair follicle stem cells and spur new hair growth,” said William Lowry, Ph.D., scientific co-founder, Pelage Pharmaceuticals. The discovery was made by Drs. Lowry, Heather Christofk and Michael Jung, of the University of California, Los Angeles. PP405 is designed to inhibit the mitochondrial pyruvate carrier (MPC) to specifically reactivate the dormant hair follicle stem cells.
“Hair loss is an incredibly common health problem with few effective solutions,” said Cathy Friedman, Executive Venture Partner, GV and Board Director, Pelage Pharmaceuticals. “GV is excited by the incredible science behind the Pelage technology. Pelage is pioneering an innovative approach with the potential to disrupt the treatment landscape, moving beyond agents that merely slow the progression of hair loss to a treatment solution that actually helps to regrow hair.”
Along with the financing and Phase 1 topline data, Pelage has announced the appointment of Qing Yu Christina Weng, M.D., as the company’s Chief Medical Officer (CMO). Dr. Weng is a physician-scientist, Harvard-trained board-certified dermatologist at Massachusetts General Hospital, and faculty at Harvard Medical School. In addition to her clinical expertise, Dr. Weng brings a background in corporate startup strategy and business development. At Pelage, Dr. Weng’s experience will inform the company’s development of PP405 as it advances to Phase 2 studies.
“The current therapeutic landscape is dominated by reformulations of existing products. Pelage is built on rigorous science and offers the opportunity to target the follicle stem cells directly,” said Dr. Weng. “I am thrilled to work with the Pelage team to advance this discovery in pursuit of a novel non-invasive solution for all people who experience 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, topical formulation, and novel mechanism of action, 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 UCLA Technology Development Group.
