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Novel protein targets tissue factor involvement in neovascular AMD
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MIAMI — Best corrected visual acuity outcomes were comparable at 6 months for the combination of ICON-1, a novel protein, plus ranibizumab compared with ranibizumab alone in patients with newly diagnosed age-related macular degeneration, according to a study presented here.
“For vision outcomes, we see equivalent gains for ranibizumab only vs. combination. We’re not seeing superiority, we’re not seeing better vision gains for the combination, at least with that dose through the time period,” Carl D. Regillo, MD, FACS, said at the Angiogenesis, Exudation, and Degeneration 2017 annual meeting.
ICON-1 is an immune-conjugate protein under development to address tissue factor involvement in inflammation and angiogenesis.
The EMERGE phase 2a study included 88 patients randomized 1:1:1 to ICON-1 (Iconic Therapeutics) 0.3 mg and ranibizumab 0.5 mg combination, ICON-1 0.3 mg, or ranibizumab 0.5 mg. Primary endpoints were mean change in best corrected visual acuity from baseline to month 3, occurrence of ocular and systemic adverse events, and mean change in central retina thickness (CRT) from baseline to month 3. Choroidal neovascularization (CNV) progression was also evaluated.
“It’s the CNV lesion progression treatment durability we’re seeing that seems to favor the combination arm over others, with a reduction of the CNV lesion and the CRT well maintained over the 6 months with fewer retreatments and a longer time to retreatment of the combination arm,” he said.
Phase 2b or phase 3 studies could examine the effects of a higher ICON-1 dose in combination with ranibizumab in a longer study duration, Regillo said. – by Robert Linnehan
References:
Regillo CD. ICON-1 in the treatment of neovascular AMD. Presented at: Angiogenesis, Exudation, and Degeneration. Feb. 11, 2017; Miami.
Disclosure: Regillo reports he is a consultant for Genentech, Bayer, Allergan, Alcon, Iconic Therapeutics and Aerpio; he receives grants/research support from Genentech, Regeneron/Bayer, Allergan, Alcon, Iconic Therapeutics, GlaxoSmithKline and Ophthotech.
Perspective
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Pravin U. Dugel, MD
Carl D. Regillo, MD, FACS, as he always does, gave a wonderful talk. It was very fair, very balanced. The positives of the study are that the strategy to inhibit tissue factor is brand new in our field and is an entirely new scientific pathway without any similar competition. If it shows any kind of positive results, it will have a major impact.
The other positive, of course, is we have a logistic problem right now with the sustainability of our current anti-VEGFA monotherapy treatment strategy. By increasing durability, it will make our treatment much more sustainable and reduce patient treatment burden. Those are the main positive factors.
As far as things that ought to be worked on, I wonder why the monotherapy arm did not perform well and I think that needs to be investigated. Also, the path toward regulatory approval needs to be investigated because the FDA has stated that it will not consider increased durability an approvable endpoint. The FDA wants to see improved efficacy.
Nonetheless, I think Iconic Therapeutics is a terrific company. They have great people there, great advisors, they are scientifically based and I think they will study the drug further in different combinations and different doses. I look forward to more studies.
The bottom line is, in a study of this size, a small phase 2a study looking at approximately 30 patients in each arm, you look for two things. You look for an excellent safety profile and a biological signal, and I think both were seen. Therefore, I believe that further studies are indeed warranted and I sincerely look forward to hearing more about this drug.
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