Sep 30, 2026 · 10 min · 10 segments
In this podcast, expert clinicians explore emerging evidence for interferon-targeted therapies in cutaneous lupus erythematosus (CLE). Faculty review the evolving understanding of interferon signaling…
Victoria WerthHostKenneth KalunianGuestWe're looking at agents that are upstream in terms of the interferon dysregulation and the innate immune system dysregulation.
So, I mean, we have some drugs that are in development right now, which we'll be talking about.
I think that the drug that we're most focused on right now affects phosphocytogenetic cells.
And even upstream of that, we have some data focusing on toll-like receptors sub-N8 and others even higher than that, that are in their infancy in terms of development.
Yeah, I mean, I think there's clearly a feedback loop that goes on with interferons, and so they can be blocked at several levels.
To summarize about lidofilumab, they have done a really careful development program where they did a phase one trial and were able to show that with one injection, You got rid of the interferon signature by a month, and that you could see that the patients where that happened, that there was resolution of their disease or at least improvement.
And the phase two, you can definitely see there were three doses, and they all worked quite well relative to the placebo group.
And the first part of the phase two to phase three trial, which is, again, another phase two trial, showed very equal improvement in the skin very rapidly, starting to improve within two weeks, and very well-tolerated, minimal side effects.
And so this data is very encouraging, and we look forward to seeing the final phase three data reported out.
The other study was the Willow study, the Empatiran study of the TOL78 oral inhibitor.
And this similarly shows an improvement in their phase two trial of three doses relative to placebo with quick resolution or improvement starting actually at two weeks and then continuing over the course of 24 weeks of the trial.
And this was associated with a decrease in the interferon signature and improvement in the skin in a way that was quite different between the patients who got placebo relative to the three doses.
So again, we have now an ongoing phase three trial in this disease and with this agent.
We're looking at agents that are upstream in terms of the interferon dysregulation and the innate immune system dysregulation.
So, I mean, we have some drugs that are in development right now, which we'll be talking about.
I think that the drug that we're most focused on right now affects phosphocytogenetic cells.
And even upstream of that, we have some data focusing on toll-like receptors sub-N8 and others even higher than that, that are in their infancy in terms of development.
Yeah, I mean, I think there's clearly a feedback loop that goes on with interferons, and so they can be blocked at several levels.
To summarize about lidofilumab, they have done a really careful development program where they did a phase one trial and were able to show that with one injection, You got rid of the interferon signature by a month, and that you could see that the patients where that happened, that there was resolution of their disease or at least improvement.
And the phase two, you can definitely see there were three doses, and they all worked quite well relative to the placebo group.
And the first part of the phase two to phase three trial, which is, again, another phase two trial, showed very equal improvement in the skin very rapidly, starting to improve within two weeks, and very well-tolerated, minimal side effects.
And so this data is very encouraging, and we look forward to seeing the final phase three data reported out.
The other study was the Willow study, the Empatiran study of the TOL78 oral inhibitor.
And this similarly shows an improvement in their phase two trial of three doses relative to placebo with quick resolution or improvement starting actually at two weeks and then continuing over the course of 24 weeks of the trial.
And this was associated with a decrease in the interferon signature and improvement in the skin in a way that was quite different between the patients who got placebo relative to the three doses.
So again, we have now an ongoing phase three trial in this disease and with this agent.
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