On Friday, in its fourth-quarter 2023 earnings release, Inventiva SA IVA said it has voluntarily paused screening and randomization of new patients in the NATiV3 Phase 3 trial of lanifibranor in non-alcoholic steatohepatitis (NASH).
The move follows the review of a reported treatment-related Suspected Unexpected Serious Adverse Reaction (SUSAR) of elevated aminotransferases (liver enzymes) in a patient enrolled in the trial.
This SUSAR is the first reported in all clinical trials with lanifibranor.
Before the voluntary pause, Inventiva was on track to complete screening by the end of the first quarter of 2024, with over 550 patients in screening and 913 patients randomized in the NATiV3 clinical trial, including 731 in the main cohort.
The company anticipates that the pause of screening may extend the last patient’s first visit timeline to the first half of 2024.
The DMC subsequently recommended that the NATiV3 trial continue with the following modifications:
- Liver monitoring every six weeks for each patient.
- Amendment to the protocol to exclude newly screened patients diagnosed or with a predisposition to autoimmune liver or thyroid disease.
The pause in screening and randomization in NATiV3 is not impacting the publication of the topline results of Phase 2a, LEGEND, evaluating lanifibranor in combination with empagliflozin and is expected for the first quarter of 2024.
As of December 31, 2023, the company’s cash and cash equivalents amounted to €26.9 million, excluding the disbursement of the second tranche of €25 million of the unsecured loan agreement executed with the European Investment Bank received in January.
The company estimates that, including the second tranche of the EIB loan, its cash balance should provide a cash runway until the beginning of the third quarter of 2024.
Inventiva’s revenues for 2023 amounted to €17.5 million, compared to €12.2 million a year ago.
Price Action: IVA shares are down 20.1% at $3.15 on the last check Friday.
Photo by hans-reniers for Unsplash
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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