SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR) has announced results from two Phase 1b studies, published in Nature Communications, showing the efficacy of rezpegaldesleukin in treating atopic dermatitis (AD) and psoriasis (PsO). The studies highlight rezpegaldesleukin's safety and its potential in providing durable improvements in disease activity and patient outcomes.
Rezpegaldesleukin, a novel interleukin-2 receptor (IL-2R) agonist, has been shown to enhance the activity of regulatory T cells (Tregs). The Phase 1b trials, which were randomized, double-blind, and placebo-controlled, assessed the drug's effects on patients with moderate-to-severe AD and chronic plaque PsO. The results demonstrated that rezpegaldesleukin safely increased Tregs and improved disease outcomes for at least 36 weeks post-treatment.
Dr. Jonathan Silverberg, the lead study author, emphasized the significance of these findings, marking the clinical validation of the Treg hypothesis in chronic inflammatory skin diseases. Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar, pointed out that the serum biomarker analysis supports the drug's ability to modulate immunoregulatory pathways, which may account for its rapid onset and lasting efficacy.
Patients with AD treated with higher doses of rezpegaldesleukin saw an 83% improvement in the Eczema Area and Severity Index (EASI) score after 12 weeks. Moreover, significant EASI improvements were maintained in a majority of patients for 36 weeks after ceasing treatment. The clinical improvements were accompanied by sustained increases in CD25bright Tregs.
The data also provided mechanistic insights through serum proteomic biomarkers and the delayed-type hypersensitivity (DTH) mouse model, suggesting a potential mechanism for the durable efficacy observed.
Nektar Therapeutics is planning to report topline data from ongoing Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata next year. The company, which specializes in developing treatments for autoimmune and chronic inflammatory diseases, is also working on other investigational drugs targeting the immune system.
This news is based on a press release statement issued by Nektar Therapeutics on October 29, 2024.
In other recent news, Nektar Therapeutics has released clinical data from a Phase 1 study of NKTR-255, an IL-15 receptor agonist, utilized alongside CD19-22 CAR-T cell therapy for patients with B-cell acute lymphoblastic leukemia. The study, conducted by Stanford Medicine, determined that NKTR-255 doubled the 12-month relapse-free/progression-free survival rate compared to historical controls. Eight out of nine participants achieved complete remission with no detectable residual disease, suggesting potential for long-term treatment outcomes.
In other developments, BTIG recently upgraded Nektar Therapeutics' stock, based on the potential of the company's investigational drug, rezpegaldesleukin. The firm identified a significant gap between Nektar's market valuation and the potential of rezpegaldesleukin, particularly in treating inflammatory and autoimmune diseases. BTIG's analysis indicates that the market has yet to fully adjust to the drug's prospects.
Furthermore, Nektar Therapeutics has clarified previous inaccuracies in Phase 1b data of rezpegaldesleukin reported by Eli Lilly (NYSE:LLY), following the termination of their partnership. These recent developments underscore the increasing recognition of Nektar Therapeutics in the biopharmaceutical landscape.
InvestingPro Insights
As Nektar Therapeutics (NASDAQ:NKTR) advances its promising rezpegaldesleukin studies, investors may find additional context from recent financial data and expert analysis. According to InvestingPro, Nektar's market capitalization stands at $252.19 million, reflecting the market's current valuation of the company's potential.
InvestingPro Tips highlight that Nektar holds more cash than debt on its balance sheet, which could provide financial flexibility as it progresses through costly clinical trials. This strong liquidity position is further supported by the fact that Nektar's liquid assets exceed its short-term obligations.
However, it's important to note that Nektar is currently not profitable, with a negative P/E ratio of -1.69 over the last twelve months as of Q2 2024. This is consistent with the company's stage of development, focusing on research and clinical trials rather than immediate profitability. An InvestingPro Tip indicates that analysts do not anticipate the company to be profitable this year, which is typical for biotech firms in the development phase.
Despite these challenges, Nektar has shown strong market performance, with a remarkable 187.04% price total return over the past year. This suggests that investors are optimistic about the company's pipeline, including the potential of rezpegaldesleukin.
For those interested in a deeper dive into Nektar's financials and prospects, InvestingPro offers 8 additional tips that could provide valuable insights for investment decisions.
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