SAN FRANCISCO, CA, USA I March 5, 2024 I Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata.
Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional T reg cells and engaging multiple immunoregulatory pathways.
“The start of this Phase 2b study is another significant milestone for Nektar as we advance REZPEG, a potentially transformative new mechanism for alopecia areata and other auto-immune disorders,” said Mary Tagliaferri, M.D., Chief Medical Officer at Nektar Therapeutics. “Alopecia areata is a disease where a patient’s own immune system attacks hair follicles and the resulting hair loss can be devastating for patients. Current treatments available have high relapse rates and carry potential safety challenges. As a result, there is a high unmet need for durable and well-tolerated treatment options that target the underlying dysfunction of the immune system in these patients. We believe there’s an opportunity for REZPEG to emerge as a novel biologic mechanism for alopecia patients and we look forward to our topline data from this study expected in the first half of 2025.”
Nektar’s global, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b study will investigate the efficacy and safety of REZPEG in 84 participants with severe to very severe alopecia areata over a 36-week induction treatment period. The induction treatment period will compare two different dosing regimens of REZPEG against placebo. Participants will be followed for an additional 24 weeks after the end of the treatment period to evaluate durability. Initial results from the study are anticipated in the first half of 2025.
The primary efficacy endpoint will evaluate mean percent improvement in the Severity of Alopecia Tool (SALT) at week 36. Secondary endpoints include proportion of participants with greater than or equal to 50% reduction in SALT at week 36 and other assessed timepoints and mean percent improvement in SALT at other assessed timepoints.
About Alopecia Areata
The lifetime incidence of alopecia areata is 2% in both men and women.1 Nearly 6.7 million people in the U.S. and 160 million worldwide develop alopecia areata in their lifetime. About 700,000 people in the U.S. currently have some form of alopecia areata.2 It is often associated with other auto-immune conditions as well as depression and anxiety.1 The disease has a tremendous impact on quality of life for patients.3 Available therapies for alopecia are not durable and have high relapse rates and there is an urgent unmet medical need for novel, more effective therapies for patients.
About REZPEG
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 a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets 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.
REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. In addition to this clinical trial in patients with severe to very severe alopecia areata, REZPEG is also being evaluated in a Phase 2b study in the treatment of adult patients with moderate-to-severe atopic dermatitis (REZOLVE-AD; NCT06136741). REZPEG is wholly-owned by Nektar Therapeutics.
About Nektar Therapeutics
Nektar Therapeutics is a biotechnology 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.
- Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K., Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current understanding and management. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 20: 59-90. https://doi.org/10.1111/ddg.14689
- National Alopecia Areata Foundation
- Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia Areata: Burden of Disease, Approach to Treatment, and Current Unmet Needs. Clin Cosmet Investig Dermatol. 2023;16:803-820
https://doi.org/10.2147/CCID.S376096
SOURCE: Nektar Therapeutics
Post Views: 716
SAN FRANCISCO, CA, USA I March 5, 2024 I Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata.
Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional T reg cells and engaging multiple immunoregulatory pathways.
“The start of this Phase 2b study is another significant milestone for Nektar as we advance REZPEG, a potentially transformative new mechanism for alopecia areata and other auto-immune disorders,” said Mary Tagliaferri, M.D., Chief Medical Officer at Nektar Therapeutics. “Alopecia areata is a disease where a patient’s own immune system attacks hair follicles and the resulting hair loss can be devastating for patients. Current treatments available have high relapse rates and carry potential safety challenges. As a result, there is a high unmet need for durable and well-tolerated treatment options that target the underlying dysfunction of the immune system in these patients. We believe there’s an opportunity for REZPEG to emerge as a novel biologic mechanism for alopecia patients and we look forward to our topline data from this study expected in the first half of 2025.”
Nektar’s global, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b study will investigate the efficacy and safety of REZPEG in 84 participants with severe to very severe alopecia areata over a 36-week induction treatment period. The induction treatment period will compare two different dosing regimens of REZPEG against placebo. Participants will be followed for an additional 24 weeks after the end of the treatment period to evaluate durability. Initial results from the study are anticipated in the first half of 2025.
The primary efficacy endpoint will evaluate mean percent improvement in the Severity of Alopecia Tool (SALT) at week 36. Secondary endpoints include proportion of participants with greater than or equal to 50% reduction in SALT at week 36 and other assessed timepoints and mean percent improvement in SALT at other assessed timepoints.
About Alopecia Areata
The lifetime incidence of alopecia areata is 2% in both men and women.1 Nearly 6.7 million people in the U.S. and 160 million worldwide develop alopecia areata in their lifetime. About 700,000 people in the U.S. currently have some form of alopecia areata.2 It is often associated with other auto-immune conditions as well as depression and anxiety.1 The disease has a tremendous impact on quality of life for patients.3 Available therapies for alopecia are not durable and have high relapse rates and there is an urgent unmet medical need for novel, more effective therapies for patients.
About REZPEG
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 a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets 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.
REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. In addition to this clinical trial in patients with severe to very severe alopecia areata, REZPEG is also being evaluated in a Phase 2b study in the treatment of adult patients with moderate-to-severe atopic dermatitis (REZOLVE-AD; NCT06136741). REZPEG is wholly-owned by Nektar Therapeutics.
About Nektar Therapeutics
Nektar Therapeutics is a biotechnology 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.
- Lintzeri, D.A., Constantinou, A., Hillmann, K., Ghoreschi, K., Vogt, A. and Blume- Peytavi, U. (2022), Alopecia areata – Current understanding and management. JDDG: Journal der Deutschen Dermatologischen Gesellschaft, 20: 59-90. https://doi.org/10.1111/ddg.14689
- National Alopecia Areata Foundation
- Alhanshali L, Buontempo MG, Lo Sicco KI, Shapiro J. Alopecia Areata: Burden of Disease, Approach to Treatment, and Current Unmet Needs. Clin Cosmet Investig Dermatol. 2023;16:803-820
https://doi.org/10.2147/CCID.S376096
SOURCE: Nektar Therapeutics
Post Views: 716
