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New alopecia drug regrows hair in 40% of patients -- FDA approval sought - New York Post

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They’re making gains in the hair-loss industry.

Researchers have discovered a drug to potentially solve alopecia, a condition that causes hair loss.

United States drug company Concert Pharmaceuticals is trialing a new, twice-daily pill that can combat and reverse rapid hair loss. The study of the drug found that four in 10 participants were able to regrow 80 percent or more of their hair within a year.

Specifically, the drug — called CTP-543 — seeks to reverse the effects of alopecia areata, which causes the body to attack its own hair follicles.

In the US alone, 6.8 million people suffer from alopecia, which can cause heightened depression due to hair loss. One of the more notable people who has the condition is Jada Pinkett-Smith, whose husband Will Smith slapped Chris Rock at the Oscars after Rock made a joke about Jada’s hair loss.

This week, the company released the discovery during the drug’s phase three trials, writing in a statement that it’s an “important milestone” in treatments for alopecia, which currently has no cure.

Patient with hair loss
A patient with significant hair loss underwent the treatment trials.
Concert Pharmaceuticals

“There is a great need for treatments for this challenging disease, and the results from the THRIVE-AA1 trial suggest that CTP-543 may potentially provide an important therapy for treating alopecia areata,” said Brett King, MD, who works in the Department of Dermatology and the Yale University School of Medicine and serves as a clinical investigator of the THRIVE-AA1 trials, in the statement. “We believe that CTP-543 has the potential to be a best-in-class treatment for patients with alopecia areata, a disease that has long been ignored.”

The drug inhibits enzymes – Janus kinases, or JAK1 and JAK2 – that are activated during an immune response and by inhibiting them, it can reverse the effects of alopecia. When too many of these enzymes are present, the inflammatory immune response causes hair loss. However, suppressing them can also lead to weakened immunity overall.

hair loss
Patients saw significant regrowth during the trials.
Concert Pharmaceuticals

The latest trial studied 706 adults who have alopecia, aged 18 to 65, for 24 weeks in the US, Canada and Europe. On average, the patients studied only had 16 percent of their hair at the start of the trial, with no one having more than 50 percent.

They were split into three groups: one was given a placebo, another an 8 milligrams twice-daily dose, and lastly a 12-milligram, twice-daily pill.

Both groups taking the non-placebo doses saw regrowth, with a total of 41.5 percent of the stronger dose recipients experiencing 80 percent of hair regrowth. Among those that received the lower dose, nearly 30 percent experienced the same amount of hair regrowth. In the placebo group, only 0.8 percent of the participants saw more than 80% of hair growth.

hair regrowth
Patients saw the most regrowth with the stronger dosage.
Concert Pharmaceuticals

The pharmaceuticals group said the drug was “generally well-tolerated,” with less than 5 percent of patients complaining of headaches, acne and infections.

After repeating the phase three trial again on 517 more patients, the company wants to present its findings and apply for US Food and Drug Administration approval next year.

“We are extremely grateful to the patients and teams of clinical research professionals who participate in our trials,” said King in the statement. “We’re working to change the treatment landscape and hope that CTP-543 will be one of the first FDA-approved treatment options for this serious disease.”

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