And as a result of that, we’ve brought that into the protocol, allowing these real world criteria, like worsening cough to qualify the patient as long as other elements are met the way they’re supposed to be met.
Daniel Carlson: Got you. Got you. And so, can you just — can you comment at all about your screening failure rate? And will this change that?
Dr. Zamaneh Mikhak: It should, it should. Because again, previously, some of the patients that didn’t have the specific signs and symptoms mentioned in the algorithm, they would not qualify. And now, because they’ve entered these real world criteria into the protocol, they would qualify for study participation.
Daniel Carlson: Got you. Okay. And then one question on TAC, it’s for you again, Zamaneh. You mentioned that you’re surprised how much — how little TFF TAC it takes to match your overall clinical outcome from oral tacrolimus. Can you elaborate on that and what that means from a clinical standpoint?
Dr. Zamaneh Mikhak: Yes. So patients coming — these are patients who are lung transplant recipients. They’ve had their lung transplant some time ago, six months ago or so, or more, years ago. And these are patients who — all of them are oral tacrolimus because most patients — most lung transplant recipients do go on oral tacrolimus to control rejection. And they’ve been on oral tacrolimus long enough to start to have the toxic effects of oral tacrolimus. So, these are the patients whose kidneys are shutting down. But the physician is faced with that decision of what do I do with this patient? If I continue the patient on oral tacrolimus at the dosages that I have them on, the kidneys are going to continue to worsen. So I decrease the oral tacrolimus, hoping they don’t go into rejection.
Maybe I add a different type of immune suppressant as I decrease oral tacrolimus, but that’s going to have its own toxicity. So, these are the types of patients right now in this study. So, as we take these patients, the patients are doing well from a rejection perspective. They’re not rejecting their lungs, their oral tacrolimus is keeping rejection at bay, but their kidneys are not functioning well. So, we have transitioned these patients. We have learned how to transition, how to take that dose of oral tacrolimus and understand what would be an equivalent dose in TFF TAC to keep the same blood levels. And then from there, we’ve learned how much can we slowly go down and see that the patients continue to be clinically stable. No clinical signs of rejections, no inhaled tacrolimus TFF TAC providing them with the benefits of oral tacrolimus and then starting to see the beneficial effects of lower toxicity.
So obviously, we need to dose many more patients. That’s why we think we will need approximately 10 patients to make a final call, but we were just very encouraged. TFF TAC is also the drug that when we talk with lung transplant doctors, they say this is the drug we’ve been waiting for. So there is a lot of enthusiasm to hopefully get this drug in the hands of patients and hopefully see how this transition helps with that improved efficacy and lower toxicity parameter. And in the long run, this is a drug that should be used in — assuming we show the type of response we are projecting and hoping to see, this is the type of drug that should be used in patients before they develop renal toxicity. There should be no reason for us to wait for patients to develop renal toxicity from oral tacrolimus and then change them to TFF TAC.
So in the long run, our goal would be to really have this available for patients from the start.
Daniel Carlson: Got you. That’s exciting. Thank you. And Zamaneh, thank you, you’ve obviously done a lot of work at turning these programs around. So, I want to thank you for your efforts in that regard.
Dr. Zamaneh Mikhak: Thank you.
