Despite being represented in clinical research, no solutions have been found to circumvent the effects of Alopecia areata. However, there may be hope.
On Sunday night, Jada Pinkett Smith, via her husband Will Smith’s much-discussed slap of Chris Rock following a joke about her hair loss, has again shone a bright spotlight on the autoimmune disease, Alopecia areata.
Alopecia areata is a disease that can affect a person’s immune system and their mental state as they come to grips with hair loss, often near the early age of 30. Despite being represented in biopharmaceutical news and clinical research, no solutions have been found to circumvent the disease’s effects.
According to the American Academy of Dermatology Association, alopecia is classified as an autoimmune disease, which causes the immune system to see the body as foreign, launching attacks to eradicate what is seen as a threat. In the case of alopecia, the pseudo-threat is hair follicles. There are predictive factors for future diagnosis: genetics, use of chemotherapeutic drug nivolumab, race and a diagnosis with other diseases, such as thyroid disease or atopic dermatitis. There are no cures for alopecia, but hair loss can be mitigated using physician-prescribed corticosteroids.
Arcutis Biotherapeutics, Inc. has announced it will soon be starting clinical trials for its biologic JAK1 pathway inhibitor, ARQ-255. The JAK1 pathway is a prime target for autoimmune therapies due to its role in the inflammatory response and cell maintenance. Arcutis’ candidate is uniquely formulated to penetrate levels of the skin, poising it to act more effectively in combating follicular death.
Acting upon the same JAK1 pathway, and perhaps the most promising alopecia candidate to be granted priority review by the U.S. Food and Drug Administration is Eli Lilly’s Olumiant (baricitinib). Clinical data showed regrowth of eyebrow, eyelash, and scalp hair in 75% of participants, with an impressive 90% regrowth of scalp hair according to the standardized Severity of Alopecia Tool (SALT). A formal decision on marketing approval is expected from the FDA and Japan in 2022.
AnaptysBio, Inc.’s Phase II randomized, double-blinded placebo-controlled study evaluates the safety and efficacy of rosnilimab, or ANB030, in treating moderate-to-severe alopecia. ANB030 works as a checkpoint inhibitor against programmed cell death protein-1 (PD-1). The study is expected to conclude within the next calendar year. Top-line data will be rolled out in Q2 2022.
An early Phase I study sponsored by Northwestern University investigates the off-label use of Minoxidil to reverse alopecia induced by chemotherapy. The study is currently recruiting 25 people and will monitor the degree of hair growth and quality of life. Minoxidil is currently approved by the FDA as vasodilator, marketed as Rogaine and manufactured by Pfizer.
Pfizer, partnered with Everest Medicines, is also exploring the potential applications for its immunomodulating candidate etrasimod, which is being investigated for an alopecia indication among other inflammatory and autoimmune diseases. Safety and tolerability were demonstrated in 354 participants involved in a 12-week Phase III study, however solely for the indication of ulcerative colitis.
Arena Pharmaceuticals has also taken the reigns on advancing etrasimod into the clinical scope in NCT04556734, titled “Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata.” The Phase II study is currently recruiting and aims to conclude mid-to-late 2023.
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