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Galera Lawsuit Against IQVIA / Alira Health Underscores Importance of Clinical Data Analysis Partner

Category: Lawsuit

Opportunity: Data analysis companies can use this incident to help convince potential customers of the importance of the quality of their data analysis partner

Company: Galera Therapeutics

Product/Asset: Avasopasem

Issue: Incorrect analysis of clinical trial data

Latest trigger event for Opp: May 30, 2023 SEC filing by Galera Therapeutics

Target Companies: Clinical data analysis services and software companies, CROs


Details:

On May 30, 2023, Galera Therapeutics filed a lawsuit against Alira Health Clinical and IQVIA Biotech alleging breach of contract and negligence specifically related to an error by the CROs in 2021 in the statistical program for the Phase 3 ROMAN trial of avasopasem for the reduction of severe oral mucositis (“SOM”) induced by radiotherapy in patients with locally advanced head and neck cancer. In December 2021, Galera announced that the error in the statistical program for the Phase 3 ROMAN trial had been detected. Correction of this error yielded the correct, statistically significant p-values for the primary endpoint and a key secondary endpoint of the Phase 3 ROMAN trial. This litigation is in its early stages and Galera is seeking damages.


In February 2023, the FDA accepted and granted Priority Review designation to the NDA for Avasopasem for the reduction of SOM induced by radiotherapy and PDUFA target date is August 9, 2023.


About Galera Therapeutics

Company Type: Public Company

Market Cap (7/18/23): $128,700,000

Location: Malvern, Pennsylvania

Cash (Q1 2023): $47,750,000

Burn rate/quarter: $-10,930,000

Technology Focus: Small Molecule

Latest stage asset: PDUFA Approval Decision

Indications: Severe oral mucositis (SOM)

Next readout: August 9, 2023

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Article History:

Originally posted 7/19/23 (RB)



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