Once-Daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002)

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Welcome to DataPulse from American Academy of Dermatology 2026 Annual Meeting on ReachMD. This activity, titled “Once-Daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials” is provided by TotalCME.

Dr. Gooderham:
Hello from the American Academy of Dermatology Annual Meeting 2026 here in Denver. I'm Dr. Melinda Gooderham, and today I'll review the results from two phase 3 trials, the LATITUDE-PSO-3001 and 3002.

These trials investigated once-daily oral zasocitinib for the treatment of moderate-to-severe plaque psoriasis. And zasocitinib is a potent and highly selective TYK2 inhibitor.

So these were placebo-controlled and active comparator-controlled trials that looked at zasocitinib in the 30-mg dose, and the active comparator was apremilast. At the meeting in the late breaker session, we reported up to 24 weeks as well as the randomized withdrawal period from week 40 to week 60. The co-primary endpoints for this trial were PASI 75 and a Static Physician Global Assessment of 0 or 1, or the sPGA 0/1, clear or almost clear skin.

So the relevance of these trials is that they provide the data for an effective oral option that has a rapid response and a durable response. And I'd love to go through these findings with you.

Starting with the co-primary endpoint of PASI 75, 3/4 of patients receiving zasocitinib were able to achieve the co-primary endpoint of PASI 75 at week 16, compared to only 1/3 of patients on apremilast. When we looked at the sPGA of clear or almost clear skin at week 16, 7 out of 10 patients in the zasocitinib arm were able to achieve that endpoint, compared to 3 out of 10 on apremilast and 1 out of 10 on placebo. Our targets for our psoriasis patients are usually a bit higher, PASI 90, PASI 100. And what we found was a PASI 90 in 2 of 3 patients at week 24 compared to 1 in 5 patients on apremilast. PASI 100, or completely clear skin, was seen in approximately 1/3 of patients on zasocitinib at week 16, and these results were all maintained out to week 24.

What was interesting about this study? In the 3002 study, there was a randomized withdrawal period from week 40 to week 60. So these were patients who started on zasocitinib at baseline, and at week 40, if they had achieved a PASI 75, they were re-randomized to either stay on zasocitinib or withdraw from therapy and were given placebo. And what we found that patients who stayed on zasocitinib, greater than 90% of patients maintained their clear or almost clear skin, their PASI 75 response and their PASI 90 response.

What I think was even more interesting is if patients had to stop therapy, if they were randomized to withdraw from therapy, they were off treatment for 20 weeks. And at week 60, 60% of patients were able to maintain clear or almost clear skin based on the sPGA 0/1, 70% of patients were able to maintain their PASI 75, and 1/2 of patients were able to maintain PASI 90, and that was being off treatment for 20 weeks.

For the safety assessment, the safety results were very predictable based on the mechanism of action with TYK2 inhibition. There were higher rates of upper respiratory tract infection and acne in the zasocitinib arm. However, there were higher rates of diarrhea, headache, and nausea in the apremilast arm. So these were AEs that would be predictable based on the mechanism of action.The AEs of special interest, there were no cases of tuberculosis. There were no MACE events. There was one DVT in a 69-year-old male, and there was one death i

n a 71-year-old obese female who was a smoker. She had hypertension and passed away the day after one dose of study drugs. So it was felt not to be related to the study medication.

So to summarize, we have a once-daily oral, selective, potent TYK2 inhibitor that provides a rapid response, a durable response, and the two studies showed reproducible response.

So from the 2026 AAD annual meeting, I'm Dr. Melinda Gooderham. Thank you for listening.

Announcer:
Thank you for listening to this DataPulse from American Academy of Dermatology 2026 Annual Meeting on ReachMD. This activity is provided by TotalCME. Thank you for listening.