The End of Alopecia?

Nearly 150 million people worldwide have or will develop alopecia areata, an autoimmune disorder that can cause severe hair loss. Other hair loss conditions, such as androgenetic alopecia, affect men and women, affecting even larger patient populations. Unfortunately, treatment options for both conditions are limited in their effectiveness and often come with undesirable side effects.

Though the degree of hair loss associated with alopecia areata varies in severity, the condition can affect patients of any age and it is associated with significant increases in anxiety and depression. And one study found that 13 percent of alopecia areata patients were at risk of suicide. Though excitement is building around new therapies, the existing tools in the arsenal needed to treat hair loss suffer from various safety concerns and long term limitations.

The recent announcement of the FDA’s approval of the first drug for the treatment of alopecia areata was welcome news for patients and physicians. Lilly’s baricitinib, a JAK inhibitor originally approved for rheumatoid arthritis, restored 80 percent of hair growth in approximately one third of patients after 12 months of treatment in late-stage clinical trials. Unfortunately, alopecia areata is a chronic condition, and long-term immunosuppression through use of certain drugs, such as JAK inhibitors, can have significant safety concerns, including serious infections and certain cancers.

In other words, there is a need for a safer alternative – and that’s where BiologicsMD’s translational science comes in. The story begins with academic investigators from the University of Kagawa in Japan’s Shikoku region, the Ochsner Clinic Foundation in New Orleans, and the University of Arkansas in Fayetteville; together, they initiated research into new ways to target proteins towards unique receptors in the body, leaning on expertise in x-ray crystallography, collagen binding, and parathyroid hormone biology. The team focused on an interesting combination – targeting type 1 triple-helical collagen while using either agonists or antagonists of the parathyroid hormone (PTH) receptor. In short, the team’s ambition was to develop a set of protein therapeutics that could be used to treat osteoporosis, cancer metastasis to bone, and other skin-based indications. Ultimately, the work holds great promise in meeting significant medical needs across multiple disease areas. 

But one series of early studies (investigating a compound’s ability to increase bone mineral density in various animal models of osteoporosis) took a serendipitous turn. The researchers saw significant improvements in bone mineral density, as expected – but they also saw improvements in hair growth in treated animals. Though hair growth did not feature in any endpoints, the finding made sense; type 1 triple-helical collagen – the target – is predominantly found in the bone and skin, and PTH receptor agonists are known to cause not only bone growth but also to impact regulation of the hair growth cycle.

BiologicsMD is now developing the resulting drug, BMD-1141. We are excited about our ability to translate the research team’s discovery into a potential treatment for multiple forms of hair loss – with minimal side effects. In contrast to JAK inhibitors, BMD-1141 is not immunosuppressive but instead functions by stimulating the patient’s natural hair cycle, which should restore hair growth without negatively impacting the patient’s immune system. 

To demonstrate human proof of concept for BMD-1141 in phase I clinical trials, BiologicsMD is busy developing relationships with experts in dermatology and biologics, as well as others who have an interest in serving a large and underserved patient population. We will not ignore the serious personal and social consequences of hair loss.