Biotech Values

[DewDiligence]

Roche—Phase-2 Faricimab AMD data at AAO:

https://www.businesswire.com/news/home/20181027005010/en

Genentech…today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD)…

…STAIRWAY is a 52-week study that assessed two extended dosing regimens of faricimab 6.0 mg given every 16 weeks or every 12 weeks, compared to ranibizumab [Lucentis] 0.5 mg every four weeks.

…Initial vision gains, as measured by Best Corrected Visual Acuity (BCVA), were fully maintained through to week 52 with 16- and 12-week dosing regimens. People treated with faricimab dosed every 16 weeks experienced a mean improvement of 11.4 chart letters from baseline, compared to 10.1 letters in patients treated with faricimab dosed every 12 weeks and 9.6 letters in patients treated with ranibizumab 0.5 mg dosed every four weeks.

The three treatment regimens were similar in both the proportion of patients gaining more than 15 letters and avoiding a loss of more than 15 letters. [These two metrics are often secondary endpoints in back-of-the-eye diseases.]

Roche is testing Faricimab (a/k/a RG7716) head-to-head vs Eylea in two phase-3 trials in DME.

Faricimab is a bi-specific mAb targeting VEGF-A and Ang-2. Positive phase-2 data in DME was reported in early 2018 (#msg-138469246).