The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to CINAINU (LH-8), an investigational cutaneous solution for moderate-to-severe alopecia areata in adult, adolescent, and pediatric patients aged 2 years and older, according to a press release from the biopharmaceutical company Legacy Healthcare.

The designation was supported by findings from the phase 2/3 RAAINBOW trial, a randomized, double-blind, placebo-controlled study involving 107 participants aged 2 to 17 years. According to the company, LH-8 demonstrated meaningful hair regrowth, favorable tolerability, and sustained benefits. The announcement did not provide numerical efficacy results, adverse event rates, or the duration of sustained benefit.

Breakthrough Therapy Designation is intended to accelerate the development and review of investigational treatments showing preliminary evidence of substantial improvement over available therapies but does not constitute FDA approval.

LH-8 is a multiplant botanical drug being developed for moderate-to-severe alopecia areata across age groups. According to Legacy Healthcare, it is the first FDA-regulated multiplant botanical drug to receive Breakthrough Therapy Designation.

Currently approved oral Janus kinase (JAK) inhibitors are limited to adult and adolescent patients with severe alopecia areata, leaving pediatric patients and those with moderate disease without approved treatment options. The therapies also carry boxed warnings for serious safety risks, including infections, malignancy, cardiovascular events, and thrombosis.

Legacy Healthcare is investigating LH-8 as a potential treatment in patients with moderate or severe disease and as possible continuation therapy following oral JAK inhibitor treatment.

The company is preparing a global pivotal phase 3 program evaluating LH-8 in adults, adolescents, and children with moderate-to-severe alopecia areata.

Source: Legacy Healthcare