Company plans to move REZPEG forward into Phase 2 clinical study in atopic dermatitis
SAN FRANCISCO, CA, USA I April 27, 2023 I Nektar Therapeutics (Nasdaq: NKTR) today announced that it will be regaining the full rights to REZPEG from Eli Lilly and Company.
As announced in a press release issued on April 17, Nektar plans to move forward with REZPEG and will initiate a Phase 2b study in patients with moderate-to-severe atopic dermatitis in 2023. The company will also explore other auto-immune indications for the development plan for REZPEG.
Phase 1b data for REZPEG in atopic dermatitis were presented at an investment presentation made by Eli Lilly and Company in December 2021 and at the 2022 European Academy of Dermatology (EADV). REZPEG evidenced a dose-dependent improvement over placebo for key efficacy measures of mean change in EASI, EASI-75, vIGA-AD scores, and Itch NRS ≥4-point scales. These improvements were observed for an additional 36 weeks following the 12-week treatment period.
“The promising Phase 1b data presented at the 2022 EADV conference warrant moving REZPEG forward into Phase 2 development,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC and the Director of Clinical Research and Contact Dermatitis. “The durability of the response may offer an opportunity for a quarterly maintenance dosing regimen and improved long-term disease control.”
The proof-of-concept data presented to-date on REZPEG also evidenced REZPEG’s ability to stimulate Tregs to target an immune system imbalance resulting in an improvement of disease activity in patients. In addition, REZPEG data were recently highlighted in a talk by Eric Lawrence Simpson, MD, FAAD at the 2023 American Academy of Dermatology (AAD) Annual Meeting on March 17, 2023 in the scientific session covering atopic dermatitis, as a potential future remittive therapy.
“We are pleased to be regaining full rights to REZPEG,” said Howard W. Robin, President and CEO of Nektar. “We plan to work quickly to initiate a Phase 2b study in atopic dermatitis. We believe the strong data generated to-date for REZPEG in atopic dermatitis show the significant potential for REZPEG to emerge as an innovative new mechanism with the possibility of disease resolution in a growing biologic treatment field. We are excited about REZPEG’s immune-modulatory profile and believe it could offer great hope in the future to patients who are managing this common and debilitating condition. We look forward to demonstrating this in the clinic as quickly as possible.”
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing 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.
About Rezpegaldesleukin (REZPEG, NKTR-358)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person’s body. A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is an investigational, potential first-in-class T regulatory cell stimulator that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It is designed to target the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance.
About Atopic Dermatitis
Atopic dermatitis is a chronic skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1 Atopic dermatitis is a heterogeneous disease and may be characterized by a highly variable appearance in which flares occur in an unpredictable manner.2 It is estimated that 16.5 million U.S. adults are affected by the disease with nearly 40% being diagnosed with moderate to severe disease.3
1. Weidinger S, Novak N. Lancet. 2016;387:1109-1122.
2. Langan SM, et al. Arch Dermatol. 2008;142:1109.
3. Chiesa Fuxench, Z. C. et al. J. Invest. Dermatol. 2019;139(3): 583-590.
SOURCE: Nektar Therapeutics
Post Views: 33
Company plans to move REZPEG forward into Phase 2 clinical study in atopic dermatitis
SAN FRANCISCO, CA, USA I April 27, 2023 I Nektar Therapeutics (Nasdaq: NKTR) today announced that it will be regaining the full rights to REZPEG from Eli Lilly and Company.
As announced in a press release issued on April 17, Nektar plans to move forward with REZPEG and will initiate a Phase 2b study in patients with moderate-to-severe atopic dermatitis in 2023. The company will also explore other auto-immune indications for the development plan for REZPEG.
Phase 1b data for REZPEG in atopic dermatitis were presented at an investment presentation made by Eli Lilly and Company in December 2021 and at the 2022 European Academy of Dermatology (EADV). REZPEG evidenced a dose-dependent improvement over placebo for key efficacy measures of mean change in EASI, EASI-75, vIGA-AD scores, and Itch NRS ≥4-point scales. These improvements were observed for an additional 36 weeks following the 12-week treatment period.
“The promising Phase 1b data presented at the 2022 EADV conference warrant moving REZPEG forward into Phase 2 development,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC and the Director of Clinical Research and Contact Dermatitis. “The durability of the response may offer an opportunity for a quarterly maintenance dosing regimen and improved long-term disease control.”
The proof-of-concept data presented to-date on REZPEG also evidenced REZPEG’s ability to stimulate Tregs to target an immune system imbalance resulting in an improvement of disease activity in patients. In addition, REZPEG data were recently highlighted in a talk by Eric Lawrence Simpson, MD, FAAD at the 2023 American Academy of Dermatology (AAD) Annual Meeting on March 17, 2023 in the scientific session covering atopic dermatitis, as a potential future remittive therapy.
“We are pleased to be regaining full rights to REZPEG,” said Howard W. Robin, President and CEO of Nektar. “We plan to work quickly to initiate a Phase 2b study in atopic dermatitis. We believe the strong data generated to-date for REZPEG in atopic dermatitis show the significant potential for REZPEG to emerge as an innovative new mechanism with the possibility of disease resolution in a growing biologic treatment field. We are excited about REZPEG’s immune-modulatory profile and believe it could offer great hope in the future to patients who are managing this common and debilitating condition. We look forward to demonstrating this in the clinic as quickly as possible.”
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing 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.
About Rezpegaldesleukin (REZPEG, NKTR-358)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person’s body. A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is an investigational, potential first-in-class T regulatory cell stimulator that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It is designed to target the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance.
About Atopic Dermatitis
Atopic dermatitis is a chronic skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1 Atopic dermatitis is a heterogeneous disease and may be characterized by a highly variable appearance in which flares occur in an unpredictable manner.2 It is estimated that 16.5 million U.S. adults are affected by the disease with nearly 40% being diagnosed with moderate to severe disease.3
1. Weidinger S, Novak N. Lancet. 2016;387:1109-1122.
2. Langan SM, et al. Arch Dermatol. 2008;142:1109.
3. Chiesa Fuxench, Z. C. et al. J. Invest. Dermatol. 2019;139(3): 583-590.
SOURCE: Nektar Therapeutics
Post Views: 33
