Lupuzor Pivotal Phase III Study Update
- ImmuPharma has been informed by Simbec-Orion, the contract research organisation (CRO) conducting the Company’s Phase III trial for Lupuzor™, that the ‘database lock’ is expected on 6 April 2018.
- Top line results for the trial are expected by mid-April 2018.
- Lupuzor™ is the Company’s novel drug candidate for the treatment of Lupus, an autoimmune disease which affects c.5 million individuals worldwide.
- ‘Database locking’ means that data collected from the trial will be secured and no changes/updates can be made to the database. Locking the database is necessary to prevent any changes to the data entry in randomized, blinded trials as it ensures the integrity of the data after un-blinding. Un-blinding the data is essential for the statistical analysis required to determine the trial outcome.
Tim McCarthy, Chairman, commented: “With the continued robust safety record of Lupuzor™ achieved over this trial, we look forward with confidence to reporting top line results in the near future.”
The database lock is a significant milestone for the clinical trial. Data collected during the trial forms the basis of subsequent safety and efficacy analysis. Once the data is locked the CRO can transfer the data for statistical analysis. Upon completion of the analysis ImmuPharma can determine if Lupuzor™ met the trial endpoints. Top-line readouts are expected in mid-April 2018 (previously Q1 2018). This is a minimal delay, common within the drug-development space, and allows the Company to make a thorough analysis of the trial data. With a £10 million raise completed in January, the Company remains in a strong cash position. Should Lupuzor™ successfully meet the trial endpoints, the Company will be in a strong negotiating position with potential partners.