John Bohnsack: Great. That’s really helpful. I mean I guess now moving on to the SER-155 program, and we’re looking forward to the data update in May. Could you maybe comment about like the level of excitement and feedback for the therapy you’ve seen at the initial sites and in cohort 1? And maybe give a range about how quickly you’re thinking cohort 2 can be enrolled based off that feedback and what you’re thinking about in terms of success for cohort 2.
Eric Shaff: Yes. Maybe I’ll ask Lisa to comment on both, Peyton. I mean we have a lot of excitement. I’ll tell you, there’s a disproportionate amount of our time, energy — and if I think — yours and others focus on 109, but we think that 109 is really just going to be giving up the story as it relates to the microbiome and our ability to help patients. So 155 is up next. We were really pleased to clear the preplanned DSMB at the end of the year and go into cohort 2. We were really careful and deliberate with the first cohort knowing that this is a fundamentally more complex patient population than what we’ve dealt with in the past. But we have increased the number of sites into the second cohort, and we do expect to move more quickly. But maybe Lisa can comment more on the excitement within our partners on the HCP side as it relates to 155.
Lisa von Moltke: Yes. The excitement really has been very sustained. I mean this is a big problem, both infections and GvHD are big problems in this population. And there are no great options. And I think we’re doing this trial on the backdrop of a time when antimicrobial resistance is also really coming to the fore as an issue for patients who need a lot of antibiotics, and that’s certainly this population. So we have a lot of interest, and we expect that interest to continue to fuel enrollment in cohort 2. And you asked about the kinds of things we’re looking for. I think there’ll be some of the same things we’ll be looking for in cohort 1, including the engraftment and function of the bacteria, pathogen reduction in the GI tract as well as clinical sequelae such as reduction in neutropenia and fever, potential reduction in infection and reduction in bloodstream infections in particular.
Eric Shaff: And maybe we can ask Matt just to comment. As usual, Peyton, our microbiome analyses and our clinical studies, we think, are incredibly important data sets. And maybe Matt can comment on how we think about the one that’s coming up with 155 in the first cohort.
Matthew Henn: Sure. I think Lisa hit on the key points. But from a pharmacological data perspective, we really are focused on some of the key mechanisms of action of the drug. So of course, engraftment is going to help inform our dosing strategies in this particular population. And as Eric and Lisa pointed out earlier, we had a favorable report from the Data Safety Monitoring Committee with respect to cohort 1. So of course, observing drug on board and having that favorable safety profile will be something we’ll be looking for. And then in terms of actually trying to understand the drug’s pharmacology with respect to infection, we will be looking at the reduction in bacterial pathogens. And of course, that has significant meaning on a couple of different fronts.
One, as we reduce that abundance, we would anticipate decreasing the likelihood of translocation events. So the bacteria moving from the gastrointestinal tract into the bloodstream to lead to bloodstream infection, as well as the potential reduced patient-to-patient transmission. So we’ll be looking at those types of factors. And of course, SER-155 is a designed consortia that was optimized for a certain set of pharmacological properties that include this passage of abundance but as well as protecting and repairing the epithelial barrier. And so we’ll be looking for those types of signatures in the data as well.
