Date: 2013-08-27
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 (ACP). The ACP is a component of the immune system's natural defence against infections.
Disease: dry age-related macular degeneration
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).
Latest
news:
- • On August 27, 2013, Roche has announced positive phase II results from the MAHALO study demonstrating that lampalizumab (also referred to as anti-factor D) showed a 20.4 percent reduction rate in the area of geographic atrophy (GA) at 18 months in patients with this advanced form of dry age-related macular degeneration (AMD). The MAHALO phase II data also showed no unexpected or unmanageable serious adverse events associated with lampalizumab. These data were presented at the 31st Annual Meeting of the American Society of Retina Specialists in Toronto, Ontario, Canada.
- In a specific sub-population of GA patients treated monthly with lampalizumab that were identified using exploratory biomarkers, the GA progression rate was decreased by 44 percent (p<0.005) at 18 months. In the subset of patients positive for the exploratory biomarkers who presented with better vision (20/50 to 20/100), progression of the GA area was reduced by 54 percent (p<0.005) at 18 months when treated with monthly lampalizumab. From the patient samples collected in the MAHALO study, 57 percent of patients were positive for the exploratory biomarkers. More information on the biomarkers will be shared at a future medical congress.
- Lampalizumab showed a 20.4 percent reduction rate in the area of geographic atrophy at 18 months (p<0.1170, statistically significant 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. There was no apparent treatment effect observed in the all-comer every other month dosing group. A secondary endpoint of change in GA area from baseline to month 18 was assessed by colour fundus photographs and confirmed the FAF primary outcome results.
Safety outcome measures included incidence and severity of ocular and non-ocular (systemic) adverse events (AE). Intraocular inflammation AE rates and intraocular pressure elevation AE rates were consistent with Lucentis rates for these AEs in wet AMD. The most frequently reported AEs in the study eye were associated with the injection procedure. There were no intraocular infections, no unexpected or unmanageable serious AEs, no death or ocular serious AEs suspected to be caused by study drug and no ocular serious AEs in study eye leading to treatment discontinuation.
Is
general: Yes
