The world-first trial offers hope of an alternative to JAK inhibitors.
A world-first trial of a JAK inhibitor alternative to treat alopecia areata is about to start across Australia.
Researchers Sinclair Dermatology in Melbourne are running the phase II study that will examine the efficacy and safety of EQ101 in the treatment of alopecia areata.
They are looking for about 30 male and female subjects ranging in age from 18 to 60 years with moderate to severe disease, to take part in the 33-week study, said the head of Sinclair Dermatology, Professor Rod Sinclair.
“This is a whole new technology and a world-first trial – it’s very exciting,” Professor Sinclair told Dermatology Republic.
EQ101 is a peptide inhibitor of specific inflammatory cytokines (IL-2, IL-9, IL-15) that binds to common YC signaling receptors, he explained.
“By blocking these specific disease-related cytokine signalling receptors, activation of natural killer and CD8 T cells decreases,” he said.
“This results in less inflammatory cells attacking the anagen hair bulb region, leading to reduced hair loss.”
All participants in the study will receive the same dose of 2 mg/kg IV weekly (total 24 doses). There will be no placebo.
The multicentre, phase II, open-label PoC study of EQ101 is open to adults with at least 35% scalp hair loss due to alopecia areata. In addition, each subject’s current hair loss episode must have lasted at least six months but not more than seven years and there can be no appreciable improvement in terminal hair regrowth within 6 months of baseline.
During the 24-week treatment period, participants will be dosed once weekly with EQ101 2 mg/kg IV. Subjects then will be followed up for an additional four weeks.
Professor Sinclair said he was expecting to see positive results from the trial, with previous research suggesting that up to 90% of patients had hair regrowth.
“We are expecting to see results because it’s targeting the cytokines,” he said.
“It’s early days but it’s really nice that Australia has been chosen to do the research.”
Professor Sinclair said pharmaceutical companies were showing greater interest in funding projects in Australia thanks to the favourable exchange rate and also “Australia’s reputation for excellence” when it came to research and drug trials.