Overview

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 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. For the 6.8 million Americans affected by alopecia areata, only two approved therapeutics are available, the immunosuppressive JAK inhibitors Olumiant (baricitinib, approved June 2022) and LITFULO (ritlecitinib, approved June 2023). However, both of these new agents have an FDA black box warning of the risk of potential serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. These risks, combined with an approximate response rate of 1/3 of patients achieving acceptable hair regrowth after a year of treatment, may limit clinical use. 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 12-50% 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 the active domain of a hormone known to stimulate 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 subcutaneous injection. Lead compound, BMD-1141, is designed to restore hair growth and prevent recurring hair loss in patients with not only alopecia areata but also androgenetic alopecia and chemotherapy-induced alopecia. BMD-1141 has demonstrated significant hair regrowth and prevention of hair loss in the highly predictive animal models of both alopecia areata and chemotherapy-induced alopecia. In addition, BiologicsMD has generated a significant body of data demonstrating the safety of BMD-1141 in vivo.

Market Opportunity: According to the National Alopecia Areata Foundation (NAAF), there are an estimated 6.8 million alopecia areata patients in the US and 155 million worldwide.  For androgenetic alopecia, 80% of men and nearly half of women are impacted at some point.

BiologicsMD

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