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SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR), currently trading at $0.87 with a market capitalization of $162.5 million, announced today that it has achieved target enrollment for its Phase 2b clinical trial, REZOLVE-AA, evaluating rezpegaldesleukin in patients with severe-to-very-severe alopecia areata. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, despite facing significant operational challenges with an EBITDA of -$130.2 million in the last twelve months. The study has enrolled 84 patients to examine the efficacy of rezpegaldesleukin, a biologic therapy designed to stimulate immune regulatory T cells, which may address immune system imbalances in autoimmune conditions.
The REZOLVE-AA study, initiated in March 2024, is a randomized, placebo-controlled trial with participants who have not received JAK inhibitors or other biologics. Patients across approximately 30 global sites, including a majority in Poland, followed by Canada and the United States, were enrolled based on their alopecia severity. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 4.24, though analysts note the company is quickly burning through its cash reserves. The primary efficacy endpoint of the study is the mean percent change in the Severity of Alopecia Tool (SALT) score after a 36-week induction period. Secondary outcomes include the proportion of participants with a significant reduction in SALT score at week 36 and other timepoints, as well as the number of patients achieving a SALT-20 score.
Howard W. Robin, President and CEO of Nektar Therapeutics, expressed gratitude to patients and physicians for their enthusiasm, which enabled the company to reach its enrollment goal. He highlighted the potential of rezpegaldesleukin to become the first novel treatment option targeting T regulatory cell dysfunction in patients with alopecia areata. Topline data from the study is expected in the fourth quarter of this year.
Alopecia areata is an autoimmune disease characterized by hair loss, affecting nearly 6.7 million people in the U.S. and 160 million worldwide. Current treatments for the condition often result in relapse and potential long-term safety issues, emphasizing the need for more effective therapies.
Rezpegaldesleukin is also being investigated in a Phase 2b clinical trial for moderate-to-severe atopic dermatitis, with the FDA granting Fast Track designation for this indication.
The information in this article is based on a press release statement from Nektar Therapeutics.
In other recent news, Nektar Therapeutics announced that its investigational drug, rezpegaldesleukin, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treating moderate-to-severe atopic dermatitis in patients aged 12 and older. This designation aims to expedite the development and review process for drugs addressing serious conditions with unmet medical needs. Additionally, Nektar has formed a collaboration with TrialNet to conduct a Phase 2 study of rezpegaldesleukin for type 1 diabetes mellitus (T1D), focusing on the drug’s safety and efficacy in newly diagnosed patients. The study, expected to start in 2025, will evaluate C-peptide levels as a primary measure of success over a 12-month period.
Analysts from H.C. Wainwright and Piper Sandler have maintained their positive outlook on Nektar, with price targets set at $6.50 and $7.00, respectively. Both firms expressed optimism about the potential of rezpegaldesleukin in expanding its indications, notably in T1D management. Furthermore, Nektar recently experienced a significant change in its senior leadership team, with Mary Tagliaferri, MD, stepping down as Senior Vice President and Chief Medical (TASE:BLWV) Officer. Brian Kotzin, MD, has been appointed as the interim Chief Medical Officer, bringing extensive experience in immunology and drug development to the role. These developments highlight Nektar’s ongoing efforts to advance its therapeutic pipeline and strengthen its executive team.
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