Flourish Biologics has developed  highly targeted, novel human therapeutics for hair loss diseases and conditions. The company’s portfolio of hair cycle stimulators are ‘first-in-class’ treatments for alopecia that restore hair growth and prevent hair loss by stimulating target receptors at the hair follicle. It demonstrates sustained therapeutic effects from a single injection dosed as infrequently as once every one to six months. The company’s core, patented technology uses a novel fusion protein that targets Type I collagen, found in skin. The molecule accomplishes this through its proprietary collagen-binding domain. Flourish’s regenerative therapies address all three major non-scarring alopecia markets: androgenetic alopecia (pattern hair loss), alopecia areata, and chemotherapy-induced alopecia.

The Problem: Androgenetic alopecia, also known as male pattern baldness, affects up to 80% of men and 50% of women over their lifetimes, impacting more than 80 million Americans. This progressive hair loss carries a psychosocial cost, and can be associated with anxiety, and in some cases depression, and social withdrawal. Existing options fall short: minoxidil offers limited average improvement (5-8%) and requires ongoing use; finasteride’s efficacy (up to 12%) is offset by sexual side effects that impact compliance. Platelet-rich plasma and nutraceuticals have no proven benefit. Hair transplant, the current gold standard, is expensive, and invasive. Alopecia areata, an autoimmune disorder affecting roughly 7 million Americans, is similarly underserved: The recently approved therapeutics, JAK inhibitors, carry an FDA black box warning for serious infection, mortality, malignancy, cardiovascular events, and thrombosis, and produce acceptable regrowth in only about a third of patients after a year.

The Solution: Flourish’s first-in-class hair cycle stimulator uses a targeting component coupled to the active domain of a hormone that stimulates hair follicle growth. The targeting domain focuses the drug to the desired site of action, resulting in negligible off-target effects and persistent hair growth for a period of months from a single injection. The lead compound is designed to restore hair growth and prevent recurring hair loss in patients with androgenetic alopecia as well as alopecia areata and chemotherapy-induced alopecia. It has demonstrated significant hair regrowth and prevention of hair loss in highly predictive animal models of both alopecia areata and chemotherapy-induced alopecia, with dose-dependent efficacy in preclinical studies comparable to a daily-dosed JAK inhibitor benchmark. Flourish has also generated a significant body of data demonstrating the safety of the molecule in vivo.