Leksum LLC, an early-stage life sciences company based in Boston, Massachusetts, is proud to announce that it recently signed an agreement with the Department of Anesthesia, Intensive Care Medicine and Pain Medicine at Medical University of Vienna covering the preparatory work leading up to the Phase I/II first-in-human clinical trials for LK-ICU. Preclinical studies of LK-ICU, which consists of extracellular vesicles derived from bone marrow mesenchymal stromal cells, indicate an almost complete preservation of both diaphragm muscle fiber size and function normally associated with the use of mechanical ventilation. Extended weaning from mechanical ventilation, often resulting from ICU-acquired weakness, is estimated to impact the quality-of-life of hundreds of thousands of patients a year in the U.S. and Europe.
Medical University of Vienna is closely affiliated with University Hospital Vienna, one of the top-ranked hospitals in the world. Phoenestra GmbH, based in Linz, Austria, which is LEKSUM's primary CMC development/manufacturing partner, is also a signatory to the agreement. Where possible, LEKSUM intends to utilize clinical data gained in Europe to support its U.S. regulatory path.
The preparatory work includes scientific and clinical planning, regulatory and compliance planning, operational and site feasibility, ethical/safety/quality considerations, general project management components as well as other related topics. LEKSUM expects to commence efforts under the agreement upon the closing of its Series A and for this planning phase to last several months.