Dive Brief:
- Apogee Therapeutics plans to start a Phase 2 study of an experimental eczema treatment in the first half of 2024 after revealing earlier-than-expected positive data from an initial study in humans.
- The placebo-controlled Phase 1 study tested various doses of the drug, called APG777, in 40 healthy volunteers. Researchers found that the medicine was generally well tolerated and had a sustained effect on targeted markers in the body, Apogee said Tuesday.
- Importantly, the study also found that APG777 has a half life of about 75 days, suggesting it could be used less frequently than existing therapies. In the Phase 2 trial, Apogee plans to give injections to patients every three or six months after an initial regimen, cutting down the total number of maintenance treatments to as little as two a year from the current norm of 13 to 26.
Dive Insight:
The study results represent the first human data from Apogee, which last year became one of the rare preclinical biopharmaceutical companies to succeed in a tough market for initial public offerings. After launching in late 2022, Apogee raised $300 million in an IPO in July 2023.
Apogee claims APG777 has the potential to be the best drug among a group of monoclonal antibodies that target a cytokine called IL-13 and are designed to compete with the blockbuster medicine Dupixent developed by Sanofi and Regeneron.
Though APG777 is still in early stages, Apogee claims its medicine compares favorably with Eli Lilly’s lebrikizumab, a much more advanced IL-13 drug that succeeded in clinical trials but failed to win Food and Drug Administration approval last year because of manufacturing issues. Apogee says it expects the induction regimen for APG777 to exceed lebrikizumab exposures by 30% to 40%.
Results of the Phase 1 study surpassed the “base case” for APG777 as a potential best-in-class option, Stifel analyst Alex Thompson wrote in a note to clients Wednesday. Late last year, Stifel analysts told investors that three-month dosing for the drug would represent a clear win, with the possibility of injections every six months representing even more upside.
For its part, Apogee said the study exceeded its own objectives and propelled the company to start Phase 2 earlier than planned. The 16-week trial will have two parts, with the first research involving about 110 patients expected to yield results in the second half of 2025, Apogee said.
Apogee shares climbed 39% in early trading Tuesday. At $58 apiece, they’ve more than tripled their value since debuting at $17 last year.