NEW YORK – InfanDx announced on Tuesday a restructuring after discontinuing development of its hypoxic-ischemic encephalopathy (HIE) test to broaden its test pipeline.
The firm decided to halt development of the test following disappointing de-blinding validation study results. An in-depth analysis of data from the firm's blinded biomarker validation study for the early detection of HIE after de-blinding "raised serious doubts about the generalizability of the study data to the intended use population" of the HypoxE test, the company said in a statement. The condition causes brain damage in newborns due to lack of oxygen, and the firm was previously eyeing submission to European regulators for clearance by the end of 2023.
The firm saw "certain subgroup effects" that were specific to the study cohort, and when modeling the performance of the biomarker panels in a data subset that was more reflective of the targeted intended use population, the performance was insufficient, InfanDx Chief Operating Officer Gunter Weiss said in a statement.
After making the decision to discontinue the HypoxE test, the company was restructured and is now "well funded to achieve key milestones" in pursuing other portfolio options.
The Cologne, Germany-based company plans to pursue additional novel opportunities in prenatal testing and infant health in addition to exploring alternative diagnostic solutions for the early detection of HIE, it said. Weiss said that InfanDx is looking at other biomarker classes for early HIE detection. As a result of ongoing partnering discussions and intellectual property-related activities, the firm isn't disclosing further details on other opportunities, it said.
Management expects to be able to raise further funding by the end of 2023 or early 2024, InfanDx said. The change in its business strategy was unanimously approved by company shareholders at a recent meeting. The firm raised €2 million ($2.2 million) in the second tranche of an oversubscribed Series A funding round in March 2022.
"With the realization that our metabolic biomarker data did not meet expectations, we were able to rapidly adapt to the situation and further strengthen our pipeline in pediatric care by adding two promising development projects to our portfolio," InfanDx CEO Achim Plum said in a statement.