Apogee buy delivers eczema trial win for AbbVie

AbbVie's long-acting anti-IL-13 antibody zumilokibart – the main asset in its $10.9 billion takeover of Apogee Therapeutics – has hit the mark in a phase 2b trial in atopic dermatitis, its lead indication.

The results come from APEX Part B, an ongoing dose-finding study in adults with moderate-to-severe AD, sometimes known as eczema, and showed that all three doses of zumilokibart achieved statistically significant improvements in the EASI-75 efficacy measure compared to placebo at week 16.

Along with having the edge on the EASI-75 scale – a 75% improvement in AD area and severity – AbbVie's drug also outperformed placebo on the more stringent EASI-90 and EASI-100 scales.

There was a separation in responses between zumilokibart and placebo from week 1, with an improvement in itching symptoms – considered the most troublesome symptom of AD – by week 2, said AbbVie. The full dataset will be revealed later today at the European Academy of Dermatology and Venereology (EADV) congress in Vienna, Austria.

AbbVie said it has selected the middle dose for phase 3 trials of zumilokibart, which it views as a potential 'pipeline-in-a-product' that could have activity in a broad range of inflammatory diseases and could be a rival to Sanofi and Regeneron's near-$18 billion blockbuster Dupixent (dupilumab), which hits both IL-4 and IL-13.

Zumilokibart has a very long half-life in the body, which means it could be dosed as infrequently as twice a year, which offers a much lower injection frequency than Dupixent (given every two to four weeks), as well as other IL-13 inhibitors like Eli Lilly's Ebglyss (lebrikizumab) and LEO Pharma's Adtralza (tralokinumab), which are also approved for AD.

That profile was the main driver for AbbVie's acquisition of Apogee earlier this year, as it sees zumilokibart as complementary to its immunology and inflammation business, which includes blockbuster drugs like IL-23p19 inhibitor Skyrizi (risankizumab) and JAK inhibitor Rinvoq (upadacitinib) and experimental therapies like anti-OX40L APG990 and anti-TSLP APG333.

Analysts at Guggenheim Securities have previously predicted that peak sales of zumilokibart could reach more than $5 billion.

"Despite significant advances in atopic dermatitis, there remains an unmet need for therapies that provide meaningful disease control with greater convenience for patients," said Kori Wallace, AbbVie's global head of immunology clinical development.

"These results support the potential of zumilokibart to rapidly improve both skin and itch," she added. "Advancing the mid-dose regimen into phase 3 and evaluating extended dosing intervals marks an important step in exploring a differentiated option for people living with AD."