Regenxbio Inc. (NASDAQ:RGNX) Q4 2019 Earnings Conference Call - Final Transcript
Feb 26, 2020 • 04:30 pm ET
Thank you. [Operator Instructions] Our first question comes from Gena Wang with Barclays. Your line is now open.
Thank you for taking my questions. I had two regarding RGX-314 gene therapy program and then one regarding the IP question. So, for the RGX-314, Ken, you mentioned our Cohort 5 data will help inform you pivotal trial final design. So what kind of data would change your thoughts on trial design dramatically? And the second question regarding the diabetic retinopathy suprachoroidal Phase 2 initiation in second half this year, will you wait and do you see the data from the wet AMD suprachoroidal data and at what dose will you start?
Hi, Gena. Thanks for the questions. So, your first one on what will we take from our 12-month data for our five cohorts from the ongoing study. So, I certainly don't foresee anything dramatically changing based on this, but with this one-time therapy, where we're seeking to have good durability and achieve visual acuity at least stability and maybe even improvement and also anatomic benefits with decreased injection burden certainly having a full 12 months is very favorable compared to the six months. So I think it's really more to, as we said, help enhance and fine tune the design in terms of things like powering, etc, based on the actual change from baseline values that we see out to 12 months. And also, in wet AMD, that longer duration is also what is generally accepted from a pivotal standpoint. So actually having real data from wet AMD to patient out to that on which we're basing our final protocol on is very comforting for us.
Your second question around suprachoroidal delivery for diabetic retinopathy. We will take advantage of the data that we have from the ongoing subretinal wet AMD study. Yes, it's a different route of administration and even a different VEGF-driven disease. But we do know anti-VEGF works for all of the as named VEGF-driven retinopathies, including wet AMD in diabetic retinopathy. So both from a safety and tolerability as well as response to anti-VEGF in terms of vascular leakiness. We think that will also help us in terms of the SCS delivery and also for diabetic retinopathy as well. We have an announcer finalized our plans there including where we would actually start what starting dose we would utilize there. So, again, we'll take full advantage of all of the 12-month data that we have for that.
Thank you. Just one quick follow up question regarding the IP. I think, could you give us a little bit more color regarding the IP dispute between you and the passage?
Hi Gena. This is Ken. Thanks for that question. We have acknowledged that we sent a letter in sort of the normal course of business related to looking to maintain and protect our intellectual property rights for shareholders to passage as well as in normal course to other companies that we view may have come into our understanding of