Sergio Traversa: But one comment I would not really focus on catabolized sites. It’s more the current situation. And we’ll see how RELIANCE I looks like, but it could be that these sites could have performed very well in RELIANCE I. So it’s more like the complexity of the all and the diagnosis and the kind of patients enrolled that make most of the difference. So I would not say that these are not good sites. These are very reputable large sites that — it is not the first depression trial they have done. They have done many of them, and they are highly qualified. So I would say it’s more the kind of patients for the monotherapy trial that was mainly responsible. Clearly, if these sites would have been limited to a single-digit patient and not to 20 plus, the impact would have been lower. But again, we’ll see what Tier 1 looks like before we make major amendment.
Andrew Tsai: Very clear. Okay, thank you.
Operator: And now we will go to Jay Olson of Oppenheimer.
Sergio Traversa: Hey, Jay.
Jay Olson: How are you? Great. Thanks for taking the question. Can you just talk about what the path forward now is to pursue monotherapy MDD indication for REL-1017?
Sergio Traversa: Yes. Thanks for the question, Jay. It is not official. And if Dr. Fava is still on the call, he may help on this. But it is really not official, some create a difference between adjunctive, and look the — you have seen one of the competitors that have got approval for treatment of MDD is a combination of 2 different antidepressants. And so the indication that we are pursuing is treatment of patient effected a major depression that have not responded adequately to the current treatment they are on. And then the doctor will decide if it’s going to be add on or it will stop the nonperforming antidepressant and replace with REL-1017 or — so we are looking for a more broader label. The trial will be done in patients that have been performing with the current treatment, also because there, the diagnosis is a lot more precise.
And there is a lot more confidence that these patients are really affected by major depression and not by personality disorder, anxiety or other similar depressions that can be confused with major depression. If we’ll be successful, it’s going to be like a broader label treatment of depression.
Jay Olson: Okay. That’s helpful. And then is there any color you could provide around what percent of patients in the RELIANCE studies have opted into the open-label extension?
Sergio Traversa: In the moment — that’s a good way — no, I don’t have that number on the top of my head. Maged, may — is the number — we —
Maged Shenouda: So they — broadly. The numbers that we have is about 75% of the patients have opted into going into the open-label study. So —
Sergio Traversa: That’s for all the trials, though, not specifically to monotherapy.
Jay Olson: Okay, great. Thank you, that’s helpful. Thanks for taking the question.
Sergio Traversa: Last time, we have around 600 patients in the long-term safety now?
Maged Shenouda: Yes.
Jay Olson: Okay. Super helpful. Thank you.
Sergio Traversa: Thank you, Jay.
Operator: And now we will go to Joon Lee of Truist Securities.
Joon Lee: Hi. Thanks for taking my questions. Do you have any data comparing the PK/PD of powder formulation to tablet formulations from REL-1017?
Sergio Traversa: Yes. Thank you, Joon. We will. But I believe the Dr. Manfredi and the team, they look at the PK profile. There is no difference between powder and the tablet.
Joon Lee: PK profile, powder and tablet. Got you.
Sergio Traversa: Yes. Well, we have the powder in solution for — from the Phase II data and the — we look at the profile in monotherapy and the blood levels, there is no difference.
