Dan Menichella, Kaleido CEO, joins Yahoo Finance’s Anjalee Khemlani, Alexis Christoforous and Kristin Myers to discuss the utilization of oral therapeutic KB109 for COVID-19 and emerging variants.
Video Transcript
ALEXIS CHRISTOFOROUS: Some health experts say that vaccines alone won't be enough to combat COVID-19, especially as it continues to mutate and new strains emerge. Kaleido Biosciences says an early trial of its experimental oral treatment actually cut recovery time, as well as hospitalizations and emergency room visits in patients with mild to moderate COVID-19. Joining us now is Kaleido's CEO, Dan Menichella, and our health reporter, Anjalee Khemlani.
Dan, thanks so much for being with us. So this therapeutic is-- it works with a microbiome-based therapy. Can you explain for us what that is and how it works in relation to COVID-19 patients?
DAN MENICHELLA: Yeah, sure, and thanks for having me. Happy to be here. So what we do is we make basically a synthetic glycan. And what we found in our study was that we were able to reduce, as you said, time to resolution of symptoms in patients, either who had a comorbidity or are over the age of 45. We were also able to reduce healthcare utilization. So emergency room visits, urgent care visits, hospitalizations by 51% overall in the study. And for patients who had a comorbidity, it was 62% reduction.
We also found, which was the primary endpoint, that the safety and tolerability of our molecule was very good. And I say these are synthetic glycans. We call these MMTs, or Microbiome Metabolic Therapy. And this is part of our technology. And this is actually what we create and what we give the patient, it's oral. You pour it into a glass of water. It doesn't change the viscosity of the water. It doesn't smell. It has maybe a slight citrusy taste. And what we're actually able to do is, we're able to steer the composition of the microbiome.
So you have, you know, trillions of bacteria, viruses, et cetera, in your microbiome. And what we're able to do is feed the good bacteria, if you will, and actually starve the pathogens. And then through selective pressure, we're able to build up the number of good bacteria that we want [INAUDIBLE] about these pathogens. And then there's a metabolic component to that. And that metabolic component is what we call short chain fatty acids. And that's the output from these bacteria that we're feeding. And that's actually what signals your immune system. And this is how we're actually able to treat the patients who have mild to moderate COVID-19 symptoms.
ANJALEE KHEMLANI: Dan, I know that that's the format, at least, this something that health experts have been asking about, specifically Dr. Fauci and others, for an oral format. But talk to me about moving into later stage trials. Because it looks like that might be a hurdle, considering where we are in the pandemic right now and the number of available people to be able to participate.
DAN MENICHELLA: Yeah, and that's certainly a good point. However, this MMT that we have, KB 109, actually works on the host immune system. So even if there are variants, we'll still be able to recruit patients and still be able to treat them. If you look at what's going on in the US, you still have 30% of patients or of people saying that they do not intend or are unlikely to take the vaccine. We do know that there are variants. We also know that in Europe, the vaccine rollout has been significantly slower.
And so we do believe that we'll be able to go into a pivotal trial. We've said that we would be able to file the I&D by Q4 of this year. And right now, we do believe that there will be enough patients for us to actually do the pivotal trial, both looking at patients in Europe, as well as here in the US.
ANJALEE KHEMLANI: Well, talk to me about that as well because I know that mild to moderate, generally speaking throughout the pandemic, has been seen as recoverable and largely in a younger population. But you're targeting this age group. Why? And how does it help then?
DAN MENICHELLA: So we're targeting the mild to moderate patient. As I said, what we're doing is we're modulating the host immune system. So we're not actually running into the variants. I mean, if we run into the variants, we're actually able to, we believe, can treat them. What we found from our K31 study was very, very interesting. It was one of the first studies in which the natural history of the mild to moderate patient was identified. And what we found was a couple of things. First off, that it takes a lot longer to get over the symptoms of COVID-19 than people previously thought.
The second thing that we found was that patients who had a comorbidity, or at least one, comorbidity, took significantly longer than even what we would call a generally healthy patient to get passive symptoms. And so, what we think is that because there's the comorbidity, there's actually other things going on. The immune system is actually trying to fight that comorbidity or that inflammatory process that's already going on. It's harder for the immune system to scale up and fight the COVID-19 virus.
And so we've targeted these patients in that way. And what we have found is that these patients who have a comorbidity need assistance in the time to resolution of symptoms. And they need assistance in terms of the ability to reduce the healthcare utilization that they might otherwise have. And this is where KB109 came in very, very nicely in that we're able to-- statistically significant, even though the study wasn't really powered-- able to reduce the time to resolution of symptoms in patients who were either 45 and over or had a comorbidity. And then we were able to reduce, as I said, healthcare utilization by 62% in patients who had at least one comorbidity.
KRISTIN MYERS: So, Dan, we hear that vaccinations right now are speeding up. And we keep talking about reaching herd immunity not just in the United States, but also around the globe. How does that impact the usage of this drug of this therapy? Is it safe for someone to take after they've been vaccinated? Or is it something that they might not even need once they've been vaccinated?
DAN MENICHELLA: Well, we haven't actually put this MMT KB109 into patients who were vaccinated. The previous study was really focused on patients who had gotten COVID-19. They had not been vaccinated previously. And so the patient type may be changing out there certainly. Herd immunity is something you should talk to Dr. Fauci about. I saw he was just on. He would know more than I would about that.
But if you look at it, there are a couple of big pharma companies still making molecules to help treat COVID-19. We believe that KB109 is an excellent molecule. It's oral, as I said, so we're not looking at an antibody where you need an infusion. This is something that a patient can take at home in combination with supportive self-care, which would be typically your Advil, your fluids, your zinc. I know some people take zinc.
And we believe that over time, COVID-19 is going to be here. I think the CDC and even Dr. Fauci have said that COVID-19 will be here for quite some time. So we believe that it's worthwhile to go after this, that there will be a future commercial opportunity. And I think there's a couple of big pharma companies, as I say, that would probably agree with that.