Dive Brief:
- Apogee Therapeutics said Monday that its shot for eczema met the main goal in the maintenance stage of a Phase 2 clinical trial, providing, after a year of treatment, sustained relief to most enrollees who responded during the initial portion of the study.
- Apogee is positioning the shot, called zumilokibart, to take on established, antibody-based eczema drugs —like Sanofi and Regeneron Pharmaceuticals’ Dupixent and Eli Lilly’s Ebglyss — by achieving similar effectiveness with less frequent injections. The fresh data suggest zumilokibart’s effectiveness is “in line with Dupixent and Ebglyss” when given every three or six months, Stifel analyst Alex Thompson wrote in a note to clients.
- Apogee’s is one of several next-generation drugs that developers, including Evommune, Nektar Therapeutics and Kymera Therapeutics, hope will upend the eczema market. Apogee shares jumped north of 20% in Monday morning trading.
Dive Insight:
Zumilokibart, formerly known as APG777, targets a signaling protein called IL-13 that triggers an immune response. Ebglyss directly inhibits IL-13’s activity, while Dupixent does so indirectly by blocking another similar protein.
In eczema, also called atopic dermatitis, Dupixent is injected every two weeks and Ebglyss every four after a loading period. The pills Rinvoq and Cibinqo, respectively from AbbVie and Pfizer, relieve patients of injections, but their drug class is linked to cardiovascular side effects. Zumilokibart could address an unmet need in eczema treatment by reducing the “injection burden” without the side effects of the pills, Apogee believes.
The data disclosed Monday relate to a subset of the trial’s 119 enrollees who “responded” over a 16-week treatment period by reaching or exceeding an endpoint called EASI-75, which reflects a 75% reduction in lesion size and severity. Those people were then re-randomized to get shots every three or six months in the maintenance phase.
At 52 weeks after their first injection, 75% those who got shots every three months maintained EASI-75, and 85% of those who got shots every six months also did so, according to Apogee.
Looking broadly at data that included both the responder and non-responder participants, the company said the study also suggested “deepening” responses over 52 weeks. On another endpoint called investigator global assessment, the percentage of all enrollees who became “clear” or “almost clear” rose from 38% at the 16-week check to 52% for the group injected every six months and 72% for the shot-every-three-months arm.
On safety, only four patients discontinued treatment because of a side effect. The most common side effect was non-infective eye inflammation at rates similar to Dupixent and Ebglyss.
The data “suggest the potential for zumi to have differentiation in a competitive [atopic dermatitis] space,” RBC Capital Markets analyst Brian Abrahams wrote in a note to clients.
Apogee is awaiting more Phase 2 data in the second quarter. Phase 3 studies are set to begin in the second half of this year.
