Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, announced 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).
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The Pelage Pharmaceutical is enrolling 60 women and men for the clinical study. PP405 is designed to reactivate dormant hair follicle stem cells to stimulate hair growth.
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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 (NCT06393452) 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.
About Pelage Pharmaceuticals
Pelage Pharmaceuticals is a clinical-stage regenerative medicine company developing novel treatments for hair loss, including androgenetic alopecia. Based on discoveries in stem cell biology made by Pelage’s scientific co-founders, the company’s novel approach is designed to reactivate dormant hair follicle stem cells and restore the body’s ability to grow hair naturally.
