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First-in-Class Hair Cycle Stimulators for the Treatment of Alopecia of Various Causes

BiologicsMD has three programs focused on restoring hair growth and preventing hair loss by stimulating receptors at the hair follicle in conditions of alopecia areata, androgenetic alopecia, and chemotherapy-induced alopecia. 

These compounds are fusion proteins with an Active Domain (parathyroid hormone agonist) coupled to a Binding Domain (collagen). The Active Domain is designed to stimulate the hair follicles to restore hair growth while the Binding Domain targets and retains the treatment in the skin for a localized and sustained response with limited off-target effects . This novel mechanism of action is expected to promote hair growth more effectively and without the serious side effects of existing treatments, with dosing as infrequent as every 1-6 months.

Only 2 FDA approved treatments – immunosuppressive JAK inhibitors. These have limited efficacy (~60% of patients do not respond to treatment), and both carry boxed warnings for risk of serious infections, mortality, malignancy, major cardiovascular and thrombosis. Corticosteroids are also used off-label, though with variable efficacy, and side effects including weight gain, mood changes, hypertension and bone loss.

Variety of treatments available with limited efficacy based on slowing the rate of hair loss rather than stimulating growth. Side effects including loss of libido and sexual dysfunction limit use.

Cooling caps that reduce the flow of blood, and therefore cytotoxic therapy, to the head have limited efficacy and do not prevent hair loss in other areas.

 

Alopecia

Normal hair growth has a well-characterized cycle where each hair follicle undergoes an Anagen growth phase, followed by a Catagen phase where growth stops, and then a resting Telogen phase. Different forms of alopecia including alopecia areata, androgenetic alopecia, and chemotherapy-induced alopecia interfere with this hair growth cycle via different mechanisms, but the net effect is the same: hair loss.

The Solution

BiologicsMD has a pipeline of fusion proteins in development for various forms of alopecia. Each compound has an Active Domain (parathyroid hormone agonist) coupled to a Binding Domain (collagen). The Active Domain has been demonstrated to activate PTH/PTHrP receptors within the bulge of hair follicles and stimulate beta-catenin (which has been shown to be a central signaling protein in stimulating hair follicle transition to the Anagen growth phase). The Binding Domain targets and retains treatment in the skin for a localized and sustained response, with limited off-target effects. Preclinical efficacy in restoration of hair growth has been demonstrated in alopecia areata and chemotherapy induced alopecia.

The Company’s lead Hair Cycle Stimulator, BMD-1141, is currently in development for the treatment of alopecia areata. Based on its novel mechanism of action and promising preclinical evidence, BMD-1141 is expected to promote hair growth more effectively and without the serious side effects of existing treatments with infrequent sc dosing every 1-6 months.

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