Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) Q1 2023 Earnings Call Transcript

So it’s all on the table for us. And I would not, I think, be fulsome without mentioning also Europe as well. It is something that has come in frame more recently in terms of discussions that we’ve been having with potential strategic partners there. And Randy could speak to this also that we will be actually, we’re in the process of getting off the ground with a similar regulatory process where we have high confidence that we’ll be able to, number one, achieve orphan disease designation. And number two, to receive scientific advice by the end of this year in terms of the pathway that we would take going forward. Maybe with that, I’ll leave it over to hear to Randy.

Randy Brenner: Yes. Hey, Julian, it’s Randy Brenner. Just with regards to your ECCMID and NTM question, we have, really since the day we launched, we’ve received significant amount of inbound interest around the potential for NUZYRA to treat NTM, particularly mycobacterium abscessus through our medical team. And that interest over the last four years really just continues to grow exponentially. We obviously don’t have the indication, so don’t proactively speak about NTM, but questions come into us all the time, and I think you’ve seen our publications that have been put out there since the launch of NUZYRA over the last four years. And there’s a significant amount of data that continually gets generated which and as data gets generated, more unsolicited questions come in through our medical team about the potential to use NUZYRA for NTM.

ECCMID last couple of weeks ago, did have an NTM poster for NUZYRA. That’s part of our real world evidence IIR program that we have out there. That looked at the short and long term durability of efficacy for NUZYRA which, again, showed data that was interesting to potential KOLs and, as other publications do generate some inbound interest and questions from the medical community. So we continue to feel good about our NTM program and our phase two study, which is why we’re doing it. And the publications that are out there continue to further support the hypothesis that we’ve laid out before starting that program.

Evan Loh: Julian, I think that the other point that I would make, and I really appreciate one of these slides that you actually had in your report about Paratek which is to look at the combinatorial use of NUZYRA. One of the things that’s important in these patients with NTM abscessus or in Mac for that matter, is that the standard of care is multiple antibiotics in combination, number one, to reduce the rate of resistance. But this is a bacteria that is very, very difficult to eradicate, if not impossible to eradicate. That being said, I think that with us realizing that, Randy and his team undertook checkerboard studies to look at synergism and/or antagonism with all of the commonly used either IV or oral antibiotics for NTM abscessus as well as Mac.

Just to remind the listeners, we saw zero antagonism with any of these agents. And in fact, with a couple of these classes, we actually saw synergism, which is actually great data that our doctors have spoken to and noted in terms of the opportunity. So when you have a once daily oral that’s as well tolerated as Randy has said here, we do believe that there continues to be nearly daily inbound inquiries into the opportunity to think about the different places that NTM can make a difference in the clinical outcomes of these very desperately ill patients.