BiologicsMD is developing highly targeted, novel human therapeutics for hair loss diseases and conditions, as well as severe bone disorders. 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 – and do so with sustained therapeutic effects in either monthly or less frequent dosing regimens. The company’s core, patented technology targets physiologically active agents to Type I collagen, found in skin and bone, via fusion to a proprietary collagen-binding domain. The company has multiple assets in three therapeutic areas (alopecia, bone repair and spinal fusion, and prevention and treatment of bone metastases in cancer).

The Problem: Alopecia areata is an autoimmune disorder characterized by patches of hair loss affecting scalp and body hair. It can be psychologically devastating. There is no FDA-approved therapy for the 6.8 million Americans affected by alopecia areata. Androgenetic alopecia, also known as male pattern baldness, affects half of all men by the age of 50, and while it is largely socially acceptable for men, it is much less so for the 4-12% of women affected by androgenetic alopecia. There are two approved therapies for androgenetic alopecia, but they mainly work by slowing down the rate at which you lose hair. Despite this relatively poor efficacy, consumers spend $4B each year in the US alone on hair-loss treatments.

The Solution: First-in-class hair cycle stimulators being developed by BiologicsMD use a targeting domain coupled to a biologic hormone that is known to stimulate the hair follicle growth cycle. 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 program is for the treatment of alopecia areata. This drug is designed to restore hair growth and prevent recurring hair loss in patients with alopecia areata. It has demonstrated significant hair regrowth and prevention of hair loss in the highly predictive animal model of alopecia areata (C3H/HeJ engrafted mice). The manufacturing process has been developed and toxicology work is ongoing.

Market Opportunity: According to the National Alopecia Areata Foundation, there are an estimated 6.8 million alopecia areata patients in the US and 155 million worldwide. Because there are currently no FDA-approved products available for treating the disease, BiologicsMD estimates that if an approved drug were available on the market with clinical evidence of efficacy and safety, that the total available market in any one year would be approximately 50% of the total estimated prevalence, approximately 3 million patients in the US alone.