GLOBAL RESEARCH ARCHIVE
Initiation of Ph3 ZENITH AD-1 and ZENITH AD-2 Highlights Strong Execution
Research evidence excerpt
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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