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Q & A Highlights

Q: How are you thinking about dose response across the three dose arms in the atopic dermatitis study? A: Jonathan Zalevsky, Chief Research and Development Officer, explained that they addressed dose response with three different cohorts evaluating both dose level and regimen. Two cohorts evaluated the 24 microgram per kilogram dose, one twice a month and the other once a month, to model the pharmacodynamic profile of Tregs. The third cohort used an 18 microgram per kilogram dose twice a month, chosen to be higher than the 12 microgram per kilogram used in Phase Ib, which showed lower efficacy.

Q: What efficacy bar on EASI or IGA would be commercially viable for advancing REZPEG into pivotal development? A: Jonathan Zalevsky noted that they are looking to replicate the Phase Ib results, which showed a dramatic separation from placebo and an 83% change from baseline. They also consider efficacy in the range of Dupixent, the current standard of care, as a successful outcome. The novel mechanism of REZPEG, which has shown a remittive effect, is expected to be appreciated in the underserved market.

Q: What is the scope of data planned for the top line Phase II atopic dermatitis results release, and what secondary endpoints should be looked for? A: Jonathan Zalevsky mentioned that the focus will be on the 16-week induction data to provide a directional understanding of the drug's performance. The greatest impact in the first-line setting would be achieved through efficacy, and they aim to replicate the marked results from Phase Ib. The novel mechanism of REZPEG, offering durable responses and low-frequency dosing, is expected to impact the market significantly.

Q: Can you provide updates on the timing or expectations for the interim PFS results from the JAVELIN Bladder Medley study? A: Jonathan Zalevsky stated that the results are expected in the middle of the year, as it is an event-driven analysis. The goal is to improve PFS and potentially OS compared to single-agent BAVENCIO in the post-chemo setting. The study is designed to test the combination of NKTR-255 plus BAVENCIO versus BAVENCIO alone.

Q: How do you expect the patient baseline in the Phase II atopic dermatitis trial to impact the placebo arm? A: Jonathan Zalevsky hopes for baseline EASI scores in the range of 25 to 30, which have been linked with lower placebo responses and better studies. They implemented several prospective features, such as limiting the US footprint and focusing on experienced dermatologists, to protect the study from high placebo response rates.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.