A Phase 3 study of the biologic drug ligelizumab in peanut allergy has been halted, at least in its present form.
Novartis, the Swiss drugmaker behind the biologic, plans instead to launch a new Phase 3 study with what a spokesperson calls “optimized dosing”.
“This decision was made based on observations from a routine, blinded efficacy review, which suggested that some patients may benefit from an improved dosing regimen,” the spokesperson said in an emailed statement.
Novartis tells Allergic Living that, pending the go-ahead from health authorities, the new Phase 3 study would get underway in the fall of 2024.
Clinical investigators and their patients enrolled in the original ligelizumab food allergy trial are being informed it has been terminated. The spokesperson says that, “after completion of the safety follow up period,” study participants will be offered the chance to continue in the revised study.
The 52-week terminated study was conducted at several allergy centers, and involved 211 participants over the age of 6. In the blinded trial, participants received injections every four weeks of either 240 milligrams or 120 mg of ligelizumab or a placebo shot.
The spokesperson stressed that termination of the original study on January 16 was not related to a safety issue.
Competing With Xolair
The change in trial approach comes not long after the Food and Drug Administration announced it was giving priority review to omalizumab (Xolair) as a food allergy treatment.
Xolair is also an injectable biologic, which Novartis is co-developing with Genentech. If the FDA approves its use in food allergy, omalizumab would become the first “anti-IgE” biologic drug for reducing reactions to multiple food allergens.