Nektar Therapeutics is going after its former partner Eli Lilly, stating that the company published incorrect results of two trials of the pipeline drug rezpegaldesleukin.
The companies collaborated in 2017 to develop the drug but Nektar found that Lilly presented erroneous data at the European Academy of Dermatology and Venereology (EADV) Congress. According to Reuters, Nektar is attempting to sue Lilly and has filed a complaint to the San Francisco federal court.
The erroneous data is from two Phase Ib studies for rezpegaldesleukin (REZPEG) for atopic dermatitis (AD) and psoriasis that were conducted by Lilly, with new data showing significant results in the AD higher dose group. The incorrect endpoints were Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI) related.
How the error was discovered
Nektar discovered the efficacy endpoints were incorrectly calculated after raw data files from the clinical studies were transferred from Lilly to Nektar. The transfer of the raw data was the first opportunity to review the complete patient data files. An independent statistical firm was employed to analyse the raw data and found it to be incorrect. The internal statistical and clinical teams in charge of the two studies at Lilly were made aware and Lilly confirmed the errors in written communications with Nektar.
A spokesperson for Lilly said: “The REZPEG Phase II trial did not meet its primary endpoints for the lead indication SLE and we therefore made the data-driven decision not to further develop the asset.
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“Our decision to terminate the collaboration with Nektar was based on the totality of evidence related to the asset, including these Phase 2 SLE results.
“Lilly complied and continues to comply with its obligations under the collaboration agreement with Nektar and is committed to the highest scientific and research standards in the development of therapies to advance patient care.
“Consistent with the collaboration agreement, Lilly terminated the agreement and Nektar has full control of the REZPEG program and the ability to further develop the asset.”
President and CEO of Nektar, Howard Robin said: “These corrected data importantly demonstrate that REZPEG, a novel and differentiated T regulatory cell mechanism, holds great promise for treating patients with AD. The data further reinforce the importance of Nektar’s renewed strategic focus on advancing REZPEG into a robust Phase IIb study in biologic-naïve patients with moderate to severe AD by October of this year.”
Nektar plans to hold an investor meeting with key opinion leaders to discuss the corrected data.
New data shows higher levels of efficacy
The new and corrected data from the AD study demonstrate that 12 weeks of REZPEG therapy at the highest dose (24 µg/kg) resulted in an average EASI score improvement of 83% with a p-value of 0.002 as compared to placebo and an EASI-75 response rate of 41%.
Originally, the incorrect data showed improvement of 66% which was non-significant. The new data of the lower dose (12 µg/kg) showed an improvement of 65% however this remains non-significant. Data from the psoriasis study showed higher improvement, however results remained non-significant.
The two double-blind, randomised, placebo-controlled studies of REZPEG evaluated safety, tolerability, and pharmacokinetics over a 12-week induction treatment period. Patients were followed for an additional 36 weeks after the end of the treatment period. The first study enrolled 44 patients with moderate-to-severe AD who had progressed on topical corticosteroids and the second study enrolled 26 patients with plaque psoriasis who were candidates for systemic therapy or phototherapy.
Rezpegaldesleukin has also been tested in systemic lupus erythematosus (SLE) with Nektar and Lilly announced negative topline data from a partner-sponsored Phase II trial (NCT04433585) on February 23. The study did not meet its primary endpoint however clinically meaningful improvements were reported in the majority of the trial’s secondary endpoints at the drug’s 900mcg mid-dose level.