Apogee to test twice-yearly dosing of atopic dermatitis biologic

05 Mar 2024
firstwordpharma.com
Phase 1Drug ApprovalPhase 2Clinical ResultAcquisition
Shares of Apogee Pharmaceuticals surged 42% Tuesday after the drugmaker said interim Phase I data for its IL-13 inhibitorIL-13 inhibitor suggested it could be effective at treating atopic dermatitis using a maintenance dosing schedule of every three- or six-month injections. The company plans to start a Phase II trial this half in patients with moderate to severe disease.
The candidate, APG777, is a monoclonal antibody (mAb) for inflammatory diseases designed to have a longer half-life and enable two to four yearly injections, while dosing regimens for currently approved biologics require 13 to 26 injections per year.
The Phase I trial enrolled 40 healthy adults to receive either 300mg, 600mg, or 1200mg doses of APG777. Pharmacokinetic data suggest the mAb has a half-life of about 75 days, and that a single dose can lead to a sustained inhibition of two key atopic dermatitis biomarkers – pSTAT6 and TARC – for at least three months, which is the longest follow-up data available.
The ascending doses were well-tolerated, with no severe adverse events or study discontinuations due to side effects.
Best-in-class prospects
Apogee said the data thus far suggests APG777 could be a potentially best-in-class IL-13 inhibitorIL-13 inhibitor and offer more favourable dosing than that of lebrikizumab from Eil Lilly, which already has physicians excited for its once-monthly injections and standard of care-comparable efficacy. For more, see Physician Views Results: Dermatologists see lebrikizumab's four-week dosing as an important value-add.
Lebrikizumab was approved by the European Commission in November as Ebglyss to treat patients with moderate-to-severe atopic dermatitis, but the FDA issued a complete response letter in October, citing issues at a third-party contract manufacturing organisation.
Almirall has rights to the IL-13-targeting mAb in Europe after licensing them from Eli Lilly, which itself gained the drug through its $1.1-billion takeover of Dermira in 2020.
In Apogee’s head-to-head preclinical studies, APG777 demonstrated equivalent or better inhibition of IL-13 signalling compared with lebrikizumab.
For the randomised, placebo-controlled Phase II study, Apogee expects to administer six injections of APG777 during the 16-week induction period, whereas lebrikizumab requires 11 over the same period. The company will then test a maintenance dosing schedule of every three- or six-month injections.
Topline data for the trial are expected in the second half of 2025.
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