Allergan, Molecular Partners' eye drug abicipar hits main goal in two late-stage trials

Allergan and Molecular Partners on Thursday announced results from the Phase III SEQUOIA and CEDAR trials demonstrating that the investigational retinal disease drug abicipar met the primary endpoint of non-inferiority to Roche and Novartis' Lucentis (ranibizumab) in treatment-naïve patients with neovascular age-related macular degeneration (AMD). "In both studies abicipar demonstrated remarkable efficacy in the eight-week and 12-week regimens," noted David Nicholson, chief R&D officer at Allergan. The companies indicated that a filing for abicipar is planned for the first half of 2019. 

The primary endpoint of the identical randomised trials is based on a proportion of patients with stable vision at week 52, with stable vision defined as vision loss of 15 letters or less in best-corrected visual acuity from baseline. The studies include three treatment arms, including eight-week and 12-week dosing regimens for abicipar, versus a group of patients treated with Lucentis. 

Allergan and Molecular Partners reported that in both studies, abicipar demonstrated similar efficacy after six or eight injections, compared with 13 Lucentis injections in the first year. SEQUOIA study results showed that the proportion of patients with stable vision in the eight-week and 12-week abicipar groups was 94.8 percent and 91.3 percent, respectively, versus 96 percent for Lucentis-treated patients. The respective proportions in the CEDAR trial were 91.7 percent, 91.2 percent and 95.5 percent.  

FirstWord reports in this therapy area - KOL Insight Age-Related Macular Degeneration (AMD): Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

In terms of safety, the companies said the overall adverse events were similar among the three treatment arms, with the rate of intraocular inflammation being higher in the abicipar groups. Specifically, the incidence of intraocular inflammation in the SEQUOIA trial was 15.7 percent and 15.3 percent, respectively, in the eight-week and 12-week abicipar arms, versus 0.6 percent for Lucentis, while in the CEDAR study, rates for the eight-week and 12-week abicipar groups were 15.1 percent and 15.4 percent, with no cases of intraocular inflammation reported among Lucentis-treated patients. "We are further analysing these results," the drugmakers stated, adding that both trials are continuing on a masked basis for a second year.  

Nicholson remarked "we have generated important findings in these trials to address a serious unmet need." He added that the companies "will continue to review these data, including inflammation findings and are working on further optimising the abicipar formulation." Detailed results from the trials will be presented at an upcoming scientific conference, the companies said. 

Abicipar, a DARPin-based anti-angiogenic drug, is also being evaluated as a potential therapy for diabetic macular oedema (DME). Earlier this year, Roche presented data from the Phase II BOULEVARD study showing that treatment with its once-monthly, intravitreal, bispecific ANG-2/VEGF antibody RG7716 led to clinically meaningful and statistically significant improvements in visual acuity gains, compared with Lucentis alone, in patients suffering vision loss due to DME. 

For relates analysis, see KOL Views: Does Roche's RG7716 have what it takes to unseat Regeneron's Eylea? 

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