Immunic

Immunic Inc is a biotherapeutic company that developed cell-based therapy approaches targeting the treatment of acute liver failure. The company's primary product candidate was the ELAD® System, a human-cell-based bio-artificial liver designed to improve survival rates in patients with severe acute liver failure. Since its inception, Immunic devote... d substantially all efforts to product development, clinical testing, and pilot manufacturing activities. In September 2018, the company reported results from VTL-308, a Phase 3 clinical trial of the ELAD System conducted in 151 subjects with severe alcoholic hepatitis. Although the ELAD-treated group demonstrated numerical improvement in survival between three months and one year following randomization, the study failed to meet its primary endpoint of statistically significant improvement in overall survival through at least ninety-one days. The secondary endpoint measuring the proportion of survivors at day ninety-one similarly showed no statistically significant difference between treatment groups. Based on these clinical outcomes, Immunic determined that the ELAD System could not be approved in the United States or European Union without substantial additional clinical trials, which would require significant capital investment and extended timelines to complete. Given the absence of commercial products or late-stage development candidates in its pipeline, the company faced considerable difficulty in securing funding for further ELAD development. Consequently, Immunic ceased development of the ELAD System for U.S. and European markets, substantially reduced its workforce, discontinued most supply and service agreements, and redirected its strategic focus toward identifying and evaluating strategic alternatives, including the potential sale of some or all company assets and related intellectual property.Read More