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Importance of Clinical Trial Data Analysis Highlighted by NKTR/LLY Dispute


Category: Clinical Trial News

Opportunity: Marketing material for clinical trial data analysis CROs and vendors

Issue: Incorrect clinical trial data

Latest trigger event for Opp: Nektar PR August 7, 2023

Target Companies: Clinical trial data analysis CROs and vendors


Details:

Nektar Therapeutics announced that efficacy data previously analyzed by Eli Lilly and/or its CRO, for rezpegaldesleukin (REZPEG) that were presented at the September 2022 EADV Congress were incorrectly calculated. The erroneous data is from two Phase 1b studies:

• Atopic Dermatitis

• Psoriasis


Upon corrected analysis EASI-related & PASI-related efficacy endpoints were met.


Nektar discovered the EASI-related and PASI-related clinical efficacy endpoints were incorrectly calculated by Lilly after all rights to REZPEG were returned to Nektar. When the raw data files were transferred to Nektar, Nektar employed an independent statistical firm to analyze the raw data de-novo, and the firm provided the new and corrected data. 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.



About Nektar Therapeutics

Company Type: Public Company

Market Cap (8/9/23): $174,800,000

Location: San Francisco, California

Cash (Q1 2023): $456,800,000

Burn rate/quarter: $-66,870,000

Technology Focus: Biologic

Latest stage asset: Phase 3

Indications: Oncology, immunology, and virology

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Article History:

Originally posted 8/15/23 (RB)




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