Genentech has announced that lampalizumab, an investigational complement factor D inhibitor, did not meet the primary efficacy endpoint in a phase 3 trial (Spectri).
“Geographic atrophy (GA) is a progressive and irreversible disease that impairs vision, and there are currently no available treatments,” said Sandra Horning, MD, chief medical officer and head of global product development. “While this result is disappointing, we will continue to evaluate results from Spectri to get a clearer understanding of the data as we await the results of our second phase 3 study, Chroma, anticipated in November.”
According to the company's press release, there was no difference in the primary outcome measure—mean change of GA lesion area at week 48—between lampalizumab patients and those randomized to sham. No further data or results of secondary outcome measures, such as visual function, are available at this time.
Dosing will now be halted in Spectri patients until the data from Chroma are analyzed.
Conducted at 275 sites in over 20 counties, Spectri and Chroma are both identical double-masked randomized phase 3 trials. Together, the trials enrolled 1,800 patients who were administered intravitreal injections of lampalizumab (10 mg) or sham every 4 to 6 weeks.
A previous phase 2 trial, MAHALO, also showed a low overall benefit of lampalizumab, yet provided evidence that the drug may have higher efficacy for the subset of dry AMD patients who carry mutations in the gene for complement factor I.