Andrea Tan: And then maybe just one quick question on REL-P11 here. Just I wanted to confirm, which indication you’re looking to study this in?
Sergio Traversa: Yes, we actually did not discuss the indication. Reason being that we don’t really know exactly, what kind of indication – we will look at. Like with the – we have to do Phase 1 and for like pharmacokinetic, all the parameters, the new formulations, the new concept, low dose chronic treatment. What we can see, is the effect that had on the rodent model that, according to the expert, it’s somewhat relevant, for what should happen in human. And what we have seen is that, there is a material decrease in body weight with no diet, with continuing the high fat, high glucose diet. So despite like high fat and high glucose diet, the rodent, they lost weight, not as much as a GLP-1, but enough to make it like a valuable drug, to treat obesity.
But at the same time, we have seen a material decrease in glucose level, like similarly, probably a little higher than metformin. And we have seen a very material effect on fat deliver. And all these, like continuing a diet with high fat, high glucose. So it kind of works on all the span of parameter metabolic syndrome. So weight, glucose, and fat deliver. So I mean, the fair assumption that the indication will be a metabolic one. We haven’t decided yet, and will be decided after Phase 2. Through a concept specifically, what the indication will be that, could be like, maybe not obesity by itself, but now it could be also combination with the GLP-1, and to overcome some of the limitation of the GLP-1, like muscle loss. But now the, we need to see the data.
And there is like a wide range of possibility all on the metabolic area, and that does suitable. And we’ll try to do something that is, a reasonable, good way to get the drug approved in a relatively short amount of time. And I don’t have the straight question, yes, the straight answer, but that’s where we are now. Waiting for, efficacy data, to make the final decision where to go.
Andrea Tan: Got it. Maybe just one follow-up there. Have you seen evidence to-date preclinically that you are avoiding loss of muscle when you’ve tracked the weight loss in these rodents?
Sergio Traversa: Well, in the preclinical, no, we haven’t looked at, we haven’t seen it, because we haven’t looked at it. And the, but it’s a fair assumption that, right, since there is no change in diet, right, the model, the rodent don’t lose weight, because they stop eating, or they reduce the food intake, like with GLP-1. So it, psilocybin is 5-HT2A agonist, and it acts at the metabolic level. So pretty much it increase, the metabolism of fat. So mechanistically is not really expected to have loss of muscles, unlike the GLP-1.
Andrea Tan: Okay. Thanks everyone.
Sergio Traversa: Thank you, Andrea.
Operator: Thank you. And your last question comes from the line of [Velma Furiati] from Guggenheim. Please go ahead.
Unidentified Analyst: And good afternoon. Thank you for taking our question. This is Velma Furiati. So following up to the previous questions, can you clarify if you already performed the real-time stat checking in the previous RELIANCE studies, or is it something that you have implemented new only now? And then I wanted to ask you about the statistical plan, if that is run by a third-party, or internally within the company? Thank you.
Sergio Traversa: Thank you for the question. If I understood correctly, the first question is that we did implement a monitoring of the sites in the study, in the previous studies, and the straight answer is no. And, it was COVID, was a little bit more complicated, to do it than now, and we didn’t do it. So, but that’s only one of the changes operational that, they’ve made in the new protocol. And so, that was one, but the required for medical record, is probably the biggest one. And so, I mean, the old goal, as we discussed, a few times, or many times, is to really enroll patients that, are affected by biological depression, and they have a history, this is an adjunctive trial. So, the patient has to come in, already on some antidepressant and, to have access to medical and pharmacy records.
It’s a good proxy, to be sure that the patient, is a real patient. These are things that we didn’t do, in the previous trial, for a variety of reasons. And so, sorry, can you repeat the second one?
Unidentified Analyst: And yes, I was asking if the statistical plan is designed by a third-party, or internally within your company?
Sergio Traversa: Yes, no, it is, well, it is, design is a collaboration. And so, but it is, we have the help of it, like a large statistical company independent that advise us, on the statistics.
Unidentified Analyst: Got it. Thank you.
Sergio Traversa: Thank you.
Operator: Thank you. There are no further questions at this time. Mr. Traversa, please go ahead.
