So, we expect to demonstrate safety superiority because SPR206 was specifically designed to reduce nephrotoxicity. So, it’s designed to reduce exposure in the kidneys and therefore, as a result, nephrotoxicity because it’s been demonstrated that if you reduce cytotoxicity in the kidneys as well as exposure in the kidneys, this would result or be associated with reduced nephrotoxicity and so, therefore, as a consequence, again, while we would be demonstrating efficacy, we do expect to see a benefit on the safety side specifically with respect to nephrotoxicity. Now, in terms of the competitive landscape, as you know, there have been beta-lactam, beta-lactamase inhibitors that have been recently developed and are being used, but we also know from the field that there’s emerging resistance to these beta-lactam, beta-lactamase inhibitors and polymyxins can be used for treatment of very difficult to treat gram-negative infections caused by beta-lactam or pseudomonas and these polymyxins are highly toxic and therefore, if you could substitute with a newer generation polymyxin that is safer on the kidneys, then clearly there would be that need.
But it is, again, hospital acquired bacterial pneumonia ventilator associated bacterial pneumonia in the hospital.
Boobalan Pachaiyappan: Can you discuss the regulatory path forward in this indication?
Sath Shukla: Yeah, we haven’t given that guidance yet, Boobalan. If you’ll bear with us as we get through the IND, then of course, we plan to give out a greater clarity on that path forward.
Kamal Hamed: And again, Boo, as we’ve disclosed, the IND is expected to be submitted by yearend and with that, in that IND, the phase two IND-enabling study will be clearly reviewed and discussed with FDA and as Sath said, we will be disclosing more details as time goes along.
Boobalan Pachaiyappan: Thanks for the clarity. And then if I can add one more. So with respect to the PIVOT-PO study, one of the exclusion criteria is create an increase. I see that you’re excluding patients with less than or equal to 30 mls per minute. So can you discuss the thought process behind using this metric as an exclusion criteria? Thank you.
Sath Shukla: Can you repeat the first part of that question, please?
Boobalan Pachaiyappan: Yeah. So in the PI PIVOT-PO study, one of the exclusion criteria is create an increase CRCI, of less than or equal to 30 mL per minute. So I would like to understand the thought process behind using this metric as an exclusion criterion in this indication.
Kamal Hamed: Okay. So, we’re excluding patients with severe renal impairment because for patients with mild or moderate renal impairment, we have a dose adjustment and therefore, these patients will be allowed into the study and we have a dosing scheme in terms of adjusting according to creatinine clearance, but not for creatinine clearance that’s less than 30 mls per minute.
Boobalan Pachaiyappan: All right. Thank you so much for taking our questions.
Operator: Thank you. And that concludes our question-and-answer session. I will now turn the call back over to Mr. Shukla.
Sath Shukla: Thank you, operator. Also, many thanks to all listening and for your participation today. Have a nice evening.
Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
