Dive Brief:
- Apogee Therapeutics is set to begin Phase 3 studies of an eczema treatment designed to compete with the mega-blockbuster medicine Dupixent after another round of successful Phase 2 testing.
- The late-stage research will kick off in the second half of this year, Apogee said Wednesday. It will include three placebo-controlled trials with about 400 patients each, with one study evaluating the medicine in combination with topical corticosteroids. Patients will be followed for a year after an initial 16-week induction period.
- Apogee released the plans as it shared the latest positive Phase 2 results and announced as much as $1.3 billion in financing from a collaboration with Blackstone Life Sciences. Apogee says it now won’t need any future equity financing.
Dive Insight:
Apogee is trying to carve out a place in a multibillion-dollar anti-inflammatory market by offering a more convenient option for patients. Its drug, known as APG777 or zumilokibart, can be injected just two or four times a year, compared with the usual regimen for existing drugs of every two to four weeks.
The latest results also suggest the possibility of improved efficacy, according to TD Cowen analyst Tyler Van Buren. While it’s difficult to compare data across trials that don’t specifically pit one medicine against another, the zumilokibart data stack up well against those seen with Sanofi and Regeneron’s Dupixent and Eli Lilly’s Ebglyss, Van Buren argues. “This sets a new bar,” he wrote in a note to clients.
Apogee is moving its middle dose into late-stage testing now that a Phase 2 study showed it outperformed both the lower and higher doses. The 16-week results found 66% of patients receiving that middle dose successfully achieved the experiment’s main goal of at least 75% skin clearance as measured by the Eczema Area and Severity Index, compared with 23% on placebo. Patients on the drug also met a set of secondary goals.
The data came from the second part of a study designed to specifically examine the effects of different doses in patients with moderate-to-severe disease. Apogee gave a top-line look from the first part last July, and in March said results had been maintained for a year.
Like Dupixent and Ebglyss, zumilokibart works by targeting a signaling protein called IL-13 that triggers an immune response that can go haywire in patients, causing inflammatory diseases such as eczema (also known as atopic dermatitis). Apogee is developing the medicine to treat other inflammatory and immunological conditions as well, and has studies underway in asthma and eosinophilic esophagitis.
The latest findings indicate that zumilokibart can be competitive, and should address questions that doctors and investors might have had with the earlier data, RBC Capital Markets analyst Brian Abrahams wrote in a note to clients.
Apogee shares rose about 3% early Wednesday on the news. Some investor optimism “may already have been baked in” to the stock, Abrahams explained.
