Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript
Mar 12, 2020 • 04:30 pm ET
Thank you. [Operator Instructions] Our first question today will come from Josh Schimmer of Evercore ISI. Please go ahead.
Good. Thanks for taking the questions and for the update. First, on Molgradex for PAP, can you comment on any ongoing discussions with the FDA for potential accelerated approval based off of the IMPALA data prior to running a second Phase 3 trial. And for the NTM indication, can you talk a little bit about some of the -- or potential disease features? I know in the past there were some commentary that GM-CSF may improve patient outcome such as anorexia or weight loss and fatigue.
And also, could you discuss the balance of the efficacy profile that you're seeing against the risk of pulmonary or disease exacerbations -- characterize the exacerbations and their severity into balancing the risk benefit of that -- of the product [Phonetic] in that indication? Thank you.
Can you repeat the question that you asked on aPAP? The line was not very clear, sorry.
Sorry. I was just asking about the status of FDA dialog for potential accelerated approval filing off of the IMPALA study prior to running a second Phase 3 trial?
Yes. This was an ongoing discussion within the company and we also had discussions with regulatory bodies. At the end, this was a decision taken into consideration everything including business decision, our priority going forward with the second study and the strength of the buyback from the IMPALA study itself.
In large part, we took into account our priorities internally with the focus on IMPALA 2, as well as what the progress in terms of approvals up there in the FDA with the type of data that we had from IMPALA. So at this point, our path is very clear, to do a definitive Phase 3 study and use that study along with the IMPALA study to have a clear path for approval. The IMPALA study itself has shortcoming that we did not feel very strongly committed for regulatory filing.
And then, Josh, the second part of your question was on the NTM study. So I'll hand over to Taneli, but we didn't quite hear all of your questions. Did you catch -- did you get it,Taneli?
Yeah. So, Josh, thank you for your question. As I heard your question, you wanted to know a little more about the non-microbiology findings and specifically made point about potential improvement of anorexia and maybe some other outcomes. And so, we have looked at some of the secondary endpoints systematically in terms of the descriptive statistics and we have no clear sign that on average we could see improvements in factors such as weight-loss or six-minute walk distance.
And this being an open-label study, it is of course incredibly hard to make judgments in small patient populations for endpoints such as this in NTM. So we feel the microbiology result is the most relevant here. But we will be looking into anecdotes in the single patient cases