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Roche’s Lampalizumab Fails in Phase III Study in Geographic Atrophy
Author: Joan McKenna
Roche announced Sept. 8 that lampalizumab failed to meet its primary endpoint in its first Phase III trial in geographic atrophy. Lampalizumab did not reduce mean change in geographic atrophy lesion area compared with sham treatment at 48 weeks.
The Swiss company said further dosing in patients would be interrupted until the results from the second Phase III study are evaluated in November 2017.
There is no approved or effective treatment for geographic atrophy.
Lampalizumab is an antigen-binding fragment of a humanized, monoclonal antibody directed against complement factor D.
In 2013, Roche announced that lampalizumab showed a 20.4 percent reduction rate in the area of geographic atrophy at 18 months in a Phase II study.
Another product candidate for geographic atrophy that targets the complement system has completed Phase II study in the US.
Apellis Pharmaceuticals of Louisville announced Aug. 24 that its complement C3 inhibitor, APL-2, met its primary endpoint in a Phase II trial for geographic atrophy.
In the FILLY trial, APL-2 showed a 29 percent reduction in the rate of GA lesion growth compared with sham at 12 months when administered monthly via intravitreal injection.