Regenxbio Inc. (NASDAQ:RGNX) Q3 2019 Earnings Conference Call - Final Transcript
Nov 05, 2019 • 04:30 pm ET
[Operator Instructions] Our first question comes from the line of Gena Wang from Barclays. Your line is open.
Thank you for taking my questions. The first question is regarding the partial clinical hold for wet AMD program. Just wondering what exactly is this surgical device and was it used across all the patients?
Hi. Gena. It's Ken. Thanks for the first question. As we mentioned, we were recently informed by FDA that they are assessing aspects of the surgical delivery device, specifically the devices that are third-party devices -- commercially third-party devices that are available and that we have used for the surgical delivery in the Phase 1/2a study. But we're still working with FDA to determine the exact cause and the precise elements of their exact concern.
So in the meantime FDA has placed the trial on a clinic -- partial clinical hold, even though the patients have already been dosed with the one-time gene therapy. I should clarify that the regular assessments and safety monitoring of all subjects enrolled continue and continue to be performed as normal. So it has been a fully enrolled study where really the last intervention was delivered about six months ago. So we're not aware of any delivery system concerns. We didn't report any concerns or complications from the Phase 1/2a study ourselves. So we're waiting for FDA to provide more details.
So for the other alternative surgical device you mentioned. How comparable -- are they compared to the previous one? And then do you also need to work on those finding before using this new device?
Yeah, I think we don't -- again no precise concern of FDA as it relates to the device and the third-party devices. I think what we have been able to do is, start to work internally to assess what may be a concern. And what we know about our internal delivery system is that, it's entirely comprised of commercial third-party devices. And if FDA has concerns, once we learn more about the specifics of their concern, we feel pretty confident that several of the components in the device system could be exchanged with something that also may be commercially available.
Okay. And my last question is regarding the suprachoroidal injection. Would you need a new IND for next years trial and at what dose would you use for the trial? And also, will you please screen existing AAV8 neutralizing antibody for that delivery?
Hi, Gena. Thanks for the question. This is Steve. So we'll be updating our plan and providing information on the plan for suprachoroidal delivery. As far as your question of whether you would need a separate IND or not. Not necessarily, certainly treating the same type of population that we're treating under the existing IND. As far as dose, we feel pretty comfortable at least in a general sense of the range of dosing based on the pre-clinical data we have, where we see very comparable transduction and also protein expression with similar concentration