A legal feud between US-based Nektar Therapeutics (NASDAQ: NKTR) and pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) is unfolding over alleged conflicts of interest and botched data analysis related to their partnership for the development of rezpegaldesleukin (REZPEG; NKTR-358), a first-in-class regulatory T (Treg) cell stimulator targeting the interleukin-2 receptor complex to address autoimmune disorders.
Review of REZPEG’s Atopic Dermatitis Data Reveals Efficacy
Nektar claims that Lilly’s analysis of data from two Phase I b trials for REZPEG as a treatment for atopic dermatitis (AD) was incorrectly calculated and presented at the September 2022 EADV Congress. Following REZPEG’s failure to achieve endpoints in a Phase II trial for systemic lupus erythematosus, Lilly ended the collaboration in April 2023. Nektar announced its intention to independently continue the development of REZPEG for AD.
Corrected Data and Nektar’s Continued Development
After the partnership’s cancellation, Nektar regained the raw data files from REZPEG clinical studies. An independent review by a statistical firm uncovered errors confirmed by Lilly. The corrected data showed significant efficacy measures for REZPEG at 12 weeks, with an 83% mean Eczema Area and Severity Index (EASI) score improvement and an EASI-75 response rate of 41%, compared to the original figures reported by Lilly.
Nektar is now preparing for a new Phase IIb study design for REZPEG in biologic-naïve patients with moderate to severe AD who have not responded to topical corticosteroids, with the study set to commence in October 2023.
Nektar’s Court Case Allegations
Nektar has filed a lawsuit against Lilly in the US District Court of California, alleging a conflict of interest and breach of contract. The lawsuit claims that after Lilly’s acquisition of Demira Inc., and its drug candidate lebrikizumab, Lilly’s commitment to developing REZPEG diminished. Nektar alleges that Lilly’s negligence in subcontracting aspects of REZPEG’s development led to the mishandling of clinical trial data. The actions of Lilly are described as “grossly negligent, reckless and/or willful,” with no formal response from Lilly at the time of writing.-Fineline Info & Tech
