Nektar Therapeutics announced today new results from its Phase 2b REZOLVE-AA study testing rezpegaldesleukin (REZPEG)—an experimental immune-modulating drug—in adults with severe (50% – 95%) to very severe alopecia areata (95% to 100% scalp hair loss). The drug is a first-in-class IL-2 pathway agonist that stimulates regulatory T-cells, and had previously received Fast Track designation from the FDA for treating alopecia areata. The global trial involved 92 participants age 18 and older who received one of two doses of the drug or a placebo over 36 weeks, with researchers measuring changes in hair coverage using the SALT score. Treatments were given as twice-monthly injections under the skin. Both treatment arms “more than doubled the SALT score reduction than that observed with placebo, with the majority of patients experiencing hair growth at Week 16 or later.” Participants in the higher-dose group had an average 28% improvement in hair coverage, compared with about 11% in the placebo group. When researchers removed data from four patients who did not meet key eligibility requirements, both drug doses showed statistically significant improvements, with hair regrowth of roughly 30%, compared with just under 6% for placebo. REZPEG also showed a strong safety profile, with the vast majority of side effects being mild or moderate and going away without intervention, including in patients treated for 52 weeks. Very few patients—just 1.4%—discontinued treatment due to side effects. These findings are being described as “proof of concept” that REZPEG can stimulate meaningful hair regrowth in people with severe to very severe alopecia areata, and they are being used to help design and justify a Phase 3 trial. Read more at Nektar Therapeutic’s website.
