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New Statistically Significant Results Reported for Clinical Efficacy Endpoints of BSA, DLQI and POEM from Phase 1b Study

New Phase 2a Study Also Being Planned for Rezpegaldesleukin in Alopecia Areata

SAN FRANCISCO, CA, USA I September 13, 2023 I Nektar Therapeutics (Nasdaq: NKTR) today announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study. Rezpegaldesleukin is Nektar’s novel, first-in-class selective regulatory T-cell (Treg) therapy, which is being developed for the treatment of atopic dermatitis.

The company is presenting the new Phase 1b clinical efficacy endpoints for rezpegaldesleukin at its investor and analyst event today. The new data highlight rezpegaldesleukin’s important promise to help patients battling atopic dermatitis, a chronic skin condition that afflicts nearly 10% of Americans.1 The company will also present the trial designs for its Phase 2b study starting in October of rezpegaldesleukin in atopic dermatitis and its new planned Phase 2a study starting in early 2024 in alopecia areata. 

“These new data announced today for rezpegaldesleukin in atopic dermatitis demonstrate that, in addition to the strong previously reported efficacy for EASI-related endpoints, rezpegaldesleukin has the potential to be a differentiated therapeutic that could greatly improve quality-of-life for patients,” said Jonathan Zalevsky, Ph.D., Chief R&D Officer of Nektar Therapeutics. “We look forward to advancing rezpegaldesleukin into our robust Phase 2b study in biologic-naïve patients with moderate to severe atopic dermatitis in October of this year. In addition, we are excited to announce that we are also initiating a Phase 2a study of rezpegaldesleukin in patients with alopecia areata in early 2024.”

The double-blind, randomized, placebo-controlled Phase 1b study of rezpegaldesleukin in atopic dermatitis evaluated safety, tolerability, and pharmacokinetics over a 12-week induction treatment period. Patients with ≥EASI-50 response at Week 19 were followed for an additional 36 weeks after the end of the treatment period or until EASI-25 response criteria were no longer met. The first study evaluated 44 patients with moderate-to-severe AtD who had progressed on topical corticosteroids.

Highlights of final efficacy endpoints for the Phase 1b study in atopic dermatitis:

TABLE 1:

  Study Arm LS Mean %
improvement in EASI
score from baseline at
12 weeks		 p-value
  Placebo 47 –
  12 µg/kg 65 NS
  24 µg/kg 83 0.0020
   
EASI Improvement results are least squares (LS) mean percent change from baseline obtained from Mixed Model for Repeated Measures (MMRM) as specified in the statistical analysis plan (SAP) defined in the protocol (generated by independent statistical audit firm).  P-value confirmed by independent statistical audit.  
       

TABLE 2:

  Study Arm Proportion of Patients Who
Achieved an
EASI-75 Score at 12 weeks
(NRI* calculation)		 Proportion of Patients Who
Achieved an
EASI-75 Score at 12 weeks
(as observed)
  Placebo 20 % 29 %
  12 µg/kg 25 % 33 %
  24 µg/kg 41 % 58 %
   
*NRI: non-responder imputation  
       

TABLE 3:

  Study Arm LS mean % Improvement in
Affected Body Surface Area
from Baseline at 12 weeks
(BSA)		 p-value
  Placebo 36 –
  12 µg/kg 55 NS
  24 µg/kg 72 0.0158
   
BSA Improvement results are least squares (LS) mean percent change from baseline obtained from Mixed Model for Repeated Measures (MMRM) as specified in the statistical analysis plan (SAP) defined in the protocol.  
       

TABLE 4:

  Study Arm LS mean % Improvement in
Dermatology Life Quality
Index (DLQI) from baseline
at 12 weeks		 p-value
  Placebo 9 –
  12 µg/kg 48 NS
  24 µg/kg 78 0.0043
   
DLQI Improvement results are least squares (LS) mean percent change from baseline obtained from Mixed Model for Repeated Measures (MMRM) as specified in the statistical analysis plan (SAP) defined in the protocol.  
       

TABLE 5:

  Study Arm LS mean % Improvement in
Patient-Oriented Eczema
Measure (POEM) from
baseline at 12 weeks		 p-value
  Placebo 15 –
  12 µg/kg 44 NS
  24 µg/kg 58 0.0100
   
POEM Improvement results are least squares (LS) mean percent change from baseline obtained from Mixed Model for Repeated Measures (MMRM) as specified in the statistical analysis plan (SAP) defined in the protocol.  
       

Investor & Analyst Event

The company is hosting a virtual investor and analyst today Wednesday, September 13, 2023 at 11:00 a.m. EST / 8:00 a.m. PST to discuss these final Phase 1b data of rezpegaldesleukin (REZPEG) in patients with atopic dermatitis, the atopic dermatitis treatment landscape and the potential role of rezpegaldesleukin, Nektar’s novel, first-in-class selective regulatory T-cell (Treg) therapy, in the treatment of atopic dermatitis.

Invited speakers include:

  • Dr. Jonathan Silverberg, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Director of Clinical Research and Contact Dermatitis
  • Dr. David Rosmarin, Chair of the Department of Dermatology at Indiana University and Kampen-Norins Scholar in Dermatology;
  • Dr. Raj Chovatiya, Board Certified Dermatologist at Northwestern University.

To access the conference call, please pre-register at Nektar Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

Investors and analysts can also view slides and listen to the live audio webcast of the presentation here. The event will also be available for replay through October 13, 2023 on Nektar’s website: www.nektar.com.

About Nektar Therapeutics

Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

  1. Eczema stats. National Eczema Association. (2023, September 5). https://nationaleczema.org/research/eczema-facts/

SOURCE: Nektar Therapeutics

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