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Initiation of Ph3 ZENITH AD-1 and ZENITH AD-2 Highlights Strong Execution

发布日期: 2026-07-21研究机构: Piper Sandler Companies公司 / 股票: NKTR.OQ报告页数: 5原文语言: 英语证据页码: 1

研报英文原文证据摘录

Initiation of Ph3 ZENITH AD-1 and ZENITH AD-2 Highlights Strong Execution

nal trials in REZPEG's Ph3 ZENITH AD program. Specifically, the two PT & RECOMMENDATION

initiated trials include 52-week (24-week induction, 28-week maintenance) Ph3 ZENITH Clinical, commercial and regulatory risks for

AD-1 (NCT07690371) and ZENITH AD-2 (NCT07711418) assessing Q2W 24 µg/mL REZPEG in AD and AA

vs placebo (induction period; 2:1) in n=510 moderate-to-severe AD patients each (≥12-

Price Performance - 1 Year years old; systemic biologic/JAK inhibitor treatment-naive) with primary endpoint of IGA

0/1 and reduction ≥2-points from baseline at Week 24 (US only) as well as IGA 0/1 USD

and EASI-75 at Week 24 (non-US regions). Of note, patients who achieve EASI-75 120

and/or IGA 0/1 response at Week 24 continue into a 28-week blinded maintenance 100

period and are re-randomized 2:2:1 to monthly dosing, quarterly dosing, or placebo.

Importantly, NKTR also incorporated an open-label treatment escape arm for patients 80

who did not meet the response threshold at Week 24. Key secondary endpoints are 60

related to EASI-90, itch numeric rating scale, and patient-reported outcomes where a

prespecified assessment for asthma control is included (given ~25% of moderate-to- 40

severe AD patients have comorbid asthma). Overall, we believe initiation of the first two 20

Ph3 trials in REZPEG's AD program highlights strong execution where mgmt expects Jul-25 Sep-25 Nov-25 Jan-26 Mar-26 May-26 Jul-26

topline data mid-2028. NKTR plans to initiate Ph3 ZENITH AD-3 (prior systemic biologic Source: Bloomberg

and/or JAK inhibitor treatment experienced patients) in September 2026. We have high

PoS for REZPEG to demonstrate a competitive product profile in the Ph3 ZENITH

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