Dive Brief:
- An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
- The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.
- Nektar’s shares rose by nearly 25% in morning trading, changing hands at just over $105. Company shares haven’t reached those heights since 2022, when a cancer drug it was developing with Bristol Myers Squibb failed in clinical testing, prompting layoffs and a restructuring. Rezpegaldesleukin has additionally shown promise against eczema, where study data has also suggested a treatment response appears to deepen with extended use.
Dive Insight:
Alopecia areata affects an estimated 2% of the population and occurs when malfunctioning T cells attack hair follicles. Rezpegaldesleukin activates IL-2, a protein on immune defenders known as “regulatory” T cells that can help bring the overactive response under control.
The Phase 2 trial called REZOLVE-AA initially enrolled 92 people and randomized them to receive one of two active doses or a placebo twice monthly. It measured the treatment’s effects on what’s known as the “Severity of Alopecia Tool,” a zero to 100 score in which the top score means complete baldness of the scalp. Any score over 50 is considered “severe.”
At the 36-week mark, the high dose reduced recipients’ SALT scores by 28% and the low dose by 30%, compared with 11% for placebo, a difference that didn’t meet statistical significance. Afterwards, Nektar followed 31 enrollees who’d seen hair regrowth — 27 of whom got rezpegaldesleukin and four who received a placebo — for another 16 weeks in a blinded extension phase of the trial.
According to Nektar, after 52 weeks, 29% of the low dose recipients and 31% of the high dose recipients saw their SALT score drop to 20 or below. None of the four recruits in the placebo group hit that mark. Nektar said the data support advancement into late-stage testing.
Treatments called JAK inhibitors, among them Eli Lilly’s Olumiant and Sun Pharma’s Leqselvi, have gained approval to treat alopecia. However, they have been linked to blood clotting events, which has made physicians wary of using them.
“We are in need of a new mechanism for a first-line systemic treatment option as an alternative to the class of agents currently approved for patients,” said David Rosmarin, the chair of Indiana University’s dermatology department, in a statement provided by Nektar.
In a note to clients, Jefferies analyst Roger Song speculated that a longer “induction” period in further testing could “further enhance efficacy” and lead to a biologic that has “much cleaner safety” than JAK inhibitors.
Nektar said the adverse events associated with its drug were mild to moderate and mostly injection site reactions. No enrollee in the extension stage discontinued because of side effects.
