Release Date: March 25, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Will the upcoming data update in May include full data on cohort 3 and additional patients on cohort 2 for atopic dermatitis? What efficacy hurdles are you considering for moving into Phase 2A? A: Yes, the update will include full data for cohorts 1, 2, and 3, along with biomarker data. We are pleased with the efficacy seen in cohorts 1 and 2, showing a 25% to 35% difference between placebo and active treatment. We are considering extending the duration of therapy and are confident in our competitive position as the only selective ITK inhibitor in the field.
Q: Can you clarify your plans for cohort 4 and the rationale for using a 400 mg dose compared to the oncology trial's 200 mg dose? A: Cohort 4 is planned to use a 400 mg dose, but we will decide after reviewing cohort 3 data. The doses provide good receptor occupancy, and we are evaluating whether 100% occupancy is necessary for clinical effect in atopic dermatitis.
Q: Regarding ALPS, what is the addressable patient population, and are there specific subsets of patients ideal for soquelitinib? A: ALPS affects about 2,500 patients in the U.S. It is a genetic disease with no cure, and patients often require lifelong immunosuppressive therapies. Our preclinical studies showed dramatic efficacy in a mouse model, prompting us to explore this in humans. We believe soquelitinib could be beneficial across the ALPS patient population.
Q: For the upcoming Phase 2 atopic dermatitis trial, what subpopulations are you targeting, and what are the key endpoints? A: We plan to target moderate to severe atopic dermatitis patients who have failed topical corticosteroids or systemic therapies. The trial will likely include two dose levels and a placebo, with endpoints such as EASI 75 and IGA 0 or 1.
Q: How are you prioritizing opportunities for soquelitinib in oncology versus inflammatory diseases as you move into later-stage trials? A: We are aggressively pursuing approvals in both lymphoma and immune diseases. We recognize the differences in treatment regimens and pricing between oncology and autoimmune indications. Our strategy includes advancing second- and third-generation compounds and considering collaborations for autoimmune diseases.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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