Date: 2013-11-16
Type of
information: Results
phase: 2
Announcement: results
Company: Roche (Switzerland)
Product: lampalizumab
Action
mechanism:
- monoclonal antibody. Lampalizumab is an antigen-binding fragment (Fab) of a humanised, monoclonal antibody directed against complement factor D. Complement factor D is a rate-limiting enzyme involved in the activation of the alternative complement pathway.
Disease: geographic atrophy (advanced form of dry age-related macular degeneration (AMD)
Therapeutic
area: Ophtalmological diseases
Country:
Trial
details:
- The phase II trial was a multi-centre, randomised, single-masked, controlled study of the safety, tolerability and evidence of activity of lampalizumab in patients with GA associated with AMD. Study participants received lampalizumab injections in one eye either monthly or every other month for 18 months. The primary endpoint was change of GA area from baseline to month 18 compared with control, as assessed with fundus autofluorescence (FAF). Four genetic biomarkers were examined in MAHALO, including complement factor H (CFH), C3, C2/CFB and CFI. In the MAHALO study, most patients had a background of CFH and C2/CFB.
Latest
news:
- • On November 16, 2013, Rochehas announced additional phase II results with lampalizumab from the MAHALO study in patients with geographic atrophy (GA). GA is characterised by the irreversible loss of retinal tissue in the macula that results in permanent blind spots in a patient’s central vision. In a sub-population of GA patients positive for the Complement Factor I (CFI) biomarker, who received monthly lampalizumab, data from an exploratory analysis show a 44 percent decrease (p<0.005) in the rate of disease progression at 18 months. When lampalizumab was administered every other month, the rate of disease progression was decreased by 18 percent (p=0.23) in the biomarker defined sub-group of patients. No unexpected or unmanageable serious adverse events were detected in the MAHALO study. These data were presented at the 2013 Retina Subspecialty Day Session of the Annual Meeting at the American Academy of Ophthalmology in New Orleans, Louisiana, USA. Lampalizumab showed a 20.4 percent reduction rate in the area of geographic atrophy at 18 months that was statistically significant (p=0.1170) per pre-specified protocol criteria in patients with this advanced form of dry AMD. The efficacy assessed by FAF was observed in those receiving monthly injections beginning at month six and maintained through month 18. A secondary endpoint of change in GA area from baseline to month 18 was assessed by colour fundus photographs and these results confirmed the FAF primary endpoint outcome. In a sub-population of GA patients treated monthly with lampalizumab that were positive for the CFI exploratory biomarker, the GA progression rate was decreased by 44 percent at 18 months (p<0.005). These preliminary data show the CFI biomarker could help identify patients most likely to respond to treatment with lampalizumab.
Is
general: Yes
