Cara Therapeutics, Inc. (NASDAQ:CARA) Q3 2023 Earnings Call Transcript

Unidentified Analyst: Okay, great, thank you.

Operator: Thank you. Our next question comes from the line of Annabel Samimy of Stifel. Please go ahead, Annabel.

Annabel Samimy: Hi, thanks for taking my question. I just wanted to get a little bit more granular on what you might report out for the KIND program. So I realize that you’re not powered for statistical significance, but are you at least going to disclose the thresholds that you are looking at to have made a go/no-go decision on whatever dose it is or the sample size that you’re looking at? Is it the standard WNRS scores on an absolute basis or on a response rate basis, are we going to see any of that kind of data? Or is it just dose and trial size or statistical powering and that’s it? And then the second question I have is, I guess, you mentioned that 80% of your enrolled patients have a body surface area of less than 10%. So that means it’s dominant. Like, do you have any expectation that the patients with a greater than 10% body surface area might skew things in any strange way? Or do you feel like you’ve had enough to sort of offset some of that? Thanks.

Chris Posner: No, absolutely, Annabel. Great question. Let me turn it to Joe.

Joana Goncalves: Thank you, Annabel. So first on what we report out, we intend to report out the top line efficacy and safety data. So more than what we had originally stated of just the dose and the sample size. So sort of the typical top line data that we have provided. So that includes the 4-point Responder Analysis. And then to address your second question, indeed, we’ve always targeted this mild to moderate patient population who are very itchy, that is the itch-dominant phenotype, as that is what we saw the greatest signal in, and we’re very happy and pleased by enriching the study that we have landed with 80% of the patient population having a body surface area of less than 10%. Notably, this study is different to our care program in the sense that we are now adding difelikefalin to topical corticosteroids.

So the patients who have a greater than 10% body surface area now have a topical corticosteroid to address their skin lesions and as such bring the atopic dermatitis down to a milder form and really represent a itch dominant AD. So we feel comfortable with that. And in addition, just the mechanism of action of difelikefalin being differentiated from the topical corticosteroid as predominantly neuromodulatory in AD, we believe that it could have an additive benefit to these patients. So quite comfortable with that additional patient population who may have greater than 10% body surface area.

Annabel Samimy: Okay, great. That’s very helpful. And if I could just clarify for KORSUVA injection, should we just assume that post-April, the dialysis providers just won’t be incentivized to use it regardless of whether their patients are responding to treatment or asking for the treatment. Is it just not something that they’ll be willing to purchase because they’re not getting the right reimbursement?

Chris Posner: Well, Annabel, I think at the end of the day, policy funding will drive prescribing behavior quite simply and what we would anticipate happening is kind of what we saw in the Parsabiv world a couple years ago where you saw significant policy decisions being made at the DO level, i.e. restricting or even stopping access to this drug. I mean Vifor will continue to make this drug available, that’s for sure, but we think policy will dictate the future of this product. And given the lack of funding, I think there’ll be protocols and policies put in place at the DO level to severely limit access, which is incredibly unfortunate given the reports we’ve heard with the patients on this drug. Incredibly disappointing.

Annabel Samimy: Yeah. Okay. Great, thank you.

Chris Posner: Yep.

Operator: Thank you. Our next question comes from the line of Oren Livnat of H.C. Wainwright.