Roche ’s RG7716 (faricimab) is expected to fully enrol its two 900-patient Phase III trials in diabetic macular edema (DME) in about four or five months, according to a primary investigator.
If the enrolment target is achieved on time, topline data could be ready about one year after enrolment completion, perhaps even in time for the annual American Academy of Ophthalmology (AAO) meeting in 2020, he added.
Diabetic macular edema drug
Enrolment is going well, as it is not particularly hard to recruit patients with DME, the investigator said. The identical Yosemite (NCT03622580) and RHINE (NCT03622593) programmes enrolled their first patients in the third-quarter of 2018 and October 2018, respectively, Roche reported on 31 January. The trials were posted on the US National Library of Medicine’s ClinicalTrials.gov in August 2018.
DME is the most common cause of sight loss in diabetics.
In March, Roche outlined a market opportunity of more than CHF 1 billion ($996m) in DME by 2021. An analyst report projected peak sales of $400 million by 2024. Roche has a market cap of CHF 231 billion ($230 million). Approximately 8.3% of the US population, or 25.8 million people, had diabetes mellitus in 2010, according to the US Centers for Disease Control and Prevention, and a study estimated about 4% of diabetes patients, or 746,000 patients, had DME in 2010 (Varma, et al, JAMA Ophthalmol. 2014 Nov; 132(11): 1334–1340).
Roche has not announced any dates to release data yet, while an analyst report expects data in the third-quarter of 2021. The studies have a primary completion date of 30 September 2021, according to the ClinicalTrials.gov website.
Experts were optimistic about success in the YOSEMITE and RHINE trials given faricimab’s bispecific action on vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG-2), as well as positive Phase II results, an analyst report noted. The bispecific MOA could potentially target more disease components than the anti-VEGFs, including marketed Regeneron Pharmaceutical’s Eylea (aflibercept) and Roche’s Lucentis (ranibizumab) and off-label Avastin (bevacizumab), the analyst report stated. The report also noted the Phase III faricimab design with Eylea as the active comparator poses a particular risk to Eylea, as having head-to-head data could provide physicians with the confidence to switch agents.
Roche did not respond for comment.
by Shuan Sim in New York
Shuan Sim is a Reporter for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.