Freeline Therapeutics Holdings plc (NASDAQ:FRLN) Q2 2023 Earnings Call Transcript

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In terms of sort of expectations, again, hard to say, we’ll follow the data. But importantly, when we look at GCase levels, plasma case levels specifically are a marker for us for how our liver is expressing the gene basically that we have given. So that’s going to be a really important and key component of our endpoints and we’ll be sharing that data. The normal range for plasma GCase is about 1, if you will. It depends on the different labs. It can be between 1 and 1.5. So we’re looking at those levels compared to what would be normal within our labs as well. So we will be presenting all that data.

Operator: [Operator Instructions] Our next question comes from Dae Gon Ha from Stifel. Please go ahead with your question.

Unidentified Analyst: This is [indiscernible] on for Dae Gon. One of the key advantages of FLT201 was really the expression of in key unmet tissues like the lung and the bone marrow. Can you speak to any measurements that you’re taking, either — maybe not even in this next alts next readout, but just going forward, that will kind of help further build on preclinical findings that show that there was expression of these other tissues?

Michael Parini: Thanks for the question. Maybe Pam, you want to talk a little bit about what data we’ll be collecting during the trial? Obviously, it’s early days in this first cohort, and I think there’s a very strong correlation between plasma GCase activity and clinical outcomes. I think your question is a bit more specific about other parameters of efficacy. And so Pam, maybe you could shed a little bit of light on that.

Pamela Foulds: Sure, of course. And so as Michael mentioned, we have with strong nonclinical data demonstrating the correlation between plasma GCase and Lyso-Gb1 reduction. Lyso-Gb1 is a toxic substrate, which has a very clear correlation to in humans to clinical outcomes. In terms of what data we will be collecting or we are collecting in this study not only are we collecting, if you will, the usual suspects of hemoglobin and platelets will be looking at liver and spleen size. Getting a sense of expression or activity in those deeper tissues like lung and bone marrow, we have multiple assessments planned. We will be looking at pulmonary function tests. We’ll be looking at chest x-rays as well. We will be assessing bone density.

We’ll be looking at bone MRs, MRIs. And so those are some of the key components. We’ll be also assessing things such as fatigue, pain, quality of life. There’s a Gaucher disease severity scale that we will be assessing as well. So we’ll be utilizing multiple clinical outcomes to get some picture of efficaciousness of our product over the longer term.

Operator: And ladies and gentlemen, at this time, I’m showing no additional questions. I’d like to end today’s question-and-answer session and turn the floor back over to Michael Parini for any closing remarks.

Michael Parini: Thanks, and thank you all for your time and participation in today’s call. With the momentum we have going in FLT201, the exciting initial clinical data readout later this quarter and the promising research projects that we’ve announced, in particular, the GBA1-linked Parkinson’s disease, I truly believe we are well positioned for near- and long-term success. But before closing, I did want to thank the Freeline team for all their hard work as well as our study investigators and the patients who are participating in our trials. Thank you all, and have a good day.

Operator: Ladies and gentlemen, with that, we’ll be concluding today’s conference call and presentation. We thank you for joining. You may now disconnect your lines.

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