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.
Currently affects ~7MM in the US alone
Autoimmune mediated disease
Associated with anxiety, depression, and decreased quality of life
Current treatments
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.
Affects ~50MM men and ~30MM women in the US alone
Caused by excess hormonal stimulation of hair follicles
Significant psychosocial stressor
Current treatments
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.
Affects ~12MM patients in the US each year
Caused by cytotoxic effects of chemotherapy at keratinocytes
>50% patients report CIA as most traumatic aspect of chemotherapy
Current treatments
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.
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 (targets type1 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.