Roche's (RHHBY) DME Drug Meets Primary Endpoint in Studies
Roche RHHBY announced positive top-line results from two identically designed late-stage studies on investigational bispecific antibody, faricimab.
The studies, YOSEMITE and RHINE, are evaluating faricimab in people living with diabetic macular edema (DME).
We note that the studies have three treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase.
Both studies met their primary endpoints as results showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to Regeneron Pharmaceuticals’ REGN Eylea given every eight weeks.
The candidate was generally well-tolerated with no new safety signals identified.
More than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year one across both studies.
Whilst anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the burden of frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.
Faricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways — via angiopoietin-2 (Ang-2) and VEGF-A.
The positive results from these late-stage studies showed that faricimab has the potential to offer lasting vision improvements for DME patients, while also reducing the treatment burden associated with frequent eye injections.
Meanwhile, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. The candidate is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD).
The successful development of the candidate will strengthen Roche’s ophthalmology franchise, which already includes Lucentis.
The stock has gained 8.2% in the year so far compared with the industry’s growth of 5.3%.
DME affects 21 million people globally representing significant potential.
However, competition is stiff in the space. Regeneron’s Eylea, a VEGF inhibitor, holds a dominant position in the DME market. Novartis’ NVS Beovu is also being evaluated for DME.
Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Halozyme Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates have grown 22 cents for 2020 and 26 cents for 2021 in the past 60 days.
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