Dive Brief:
- The value of shares of San Diego biotech AnaptysBio more than doubled after news of positive topline Phase 2a proof-of-concept data in 12 people with moderate to severe atopic dermatitis showing a rapid and sustained response after a single dose.
- After a single dose of the IL-33 antibody ANB020, 83% of patients had a 50% improvement in eczema area severity index compared with baseline (EASI-50) at day 29, rising from 75% at day 15, and falling back down to 75% at day 57. The average reduction in itching was 28% and 31% compared with baseline. There were no severe adverse events.
- The Phase 2a study will continue up to 140 days post-dose, with publication at a conference once the trial completes. A Phase 2b multi-dose study is planned for the first half of 2018, in 200-300 adults patients with moderate-to-severe atopic dermatitis; data is expected in 2019.
Dive Insight:
While this is still a relatively small study, the results are being viewed positively by the markets, and will be welcomed by the approximately 4.1 million adults across the U.S. who have atopic dermatitis. AnaptysBio floated in January 2016, closing its IPO on January 31, 2017 at $15 per share. It closed yesterday at $70.31, a new high and 314% up over less than nine months.
Treatments for atopic dermatitis can be messy and inconvenient, such as lukewarm baths up to three times a day with emulsifying oils and emollients. Topical steroids are effective, but long term use isn't advised. Immunomodulators can be effective but can be costly, and calcineurin inhibitors have been linked with malignancies. Sanofi and Regeneron's Dupixent (dupilumab) has been approved in the U.S. for atopic dermatitis as a self-administered bi-weekly injection following an initial dose. While the dosing schedule hasn't yet been confirmed for ANB020, the Phase 2a studies suggest that it could be dosed less frequently than Dupixent.
"The rapid and sustained benefit observed in patients after a single dose of ANB020 is an encouraging interim result,"said Graham Ogg, professor of dermatology at University of Oxford and primary investigator of the Phase 2a study.
While these results are still early, the AnaptysBio therapy could be a game-changing treatment for these patients and offers a huge market opportunity for the company.
ANB020 is also in Phase 2a studies in severe peanut allergy and in severe eosinophilic asthma, and topline data is expected in the fourth quarter of this year, and the first half of 2018 respectively.