LEKSUM Signs Agreement with Medical University of Vienna for Preparatory Work Leading to Phase I/II Clinical Trials

Key Takeaways

  • Leksum signs an agreement with the Department of Anesthesia, Intensive Care Medicine and Pain Medicine at the Medical University of Vienna, with Phoenestra GmbH as a co-signatory, to conduct preparatory work leading up to Phase I/II first-in-human clinical trials for LK-ICU.
  • Preclinical studies show LK-ICU, consisting of extracellular vesicles derived from bone marrow mesenchymal stromal cells, nearly completely preserves diaphragm muscle fiber size and function during mechanical ventilation.
  • Leksum plans to start efforts under the agreement upon closing its Series A, expects the planning phase to last several months, and intends to use European clinical data to support its U.S. regulatory path.

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.


Leksum LLC, based in Boston, Massachusetts, is an early-stage life sciences company developing advanced biologic therapies to address acquired muscle myopathies. In addition to LK-ICU, Leksum's pipeline includes skeletal muscle conditions including sarcopenia, cancer cachexia, and muscle-loss due to the use of weight-loss drugs (i.e., GLP-1s).

Resources

Niles Chura
Chief Executive Officer
Mr. Chura possesses over two decades of leadership experience in the corporate, investment banking, and institutional investment arenas. He has held senior roles at several leading financial services firms in the U.S., including being the top-ranked Portfolio Manager at one of the largest private alternatives managers at the time ($40+B of AUM).

Mr. Chura was previously recruited to help co-launch a new capital markets strategy for a large healthcare direct lender. While there, he spearheaded an effort to acquire stressed Medicare Advantage programs. Subsequently, Mr. Chura co-founded a revenue-generating life sciences start-up that offers innovative financial and insurance solutions to help manufacturers, payers, providers, and patients manage the high cost and durability risk of potentially curative gene & cell therapies. He was awarded a patent for a related financial instrument that facilitates portability in compliance with U.S. healthcare regulations. He began his career as a field artillery officer in the U.S. Army serving overseas for three-and-a-half years.

Mr. Chura received an M.B.A. from Yale University and a B.A. in economics and government from The College of William & Mary in Virginia where he has been a guest lecturer for over 15 years. He has served as a member of the Boards of Directors for both public and private companies.
View Full Bio >>

Media Contact

Leksum LLC is an early-stage life sciences company based in Boston, Massachusetts, focused on developing innovative therapies aimed at improving patient outcomes in critical care settings.

Leksum announced a partnership with the Department of Anesthesia, Intensive Care Medicine and Pain Medicine at the Medical University of Vienna to prepare for Phase I/II clinical trials of LK-ICU, which could significantly improve patient recovery from ICU-acquired weakness caused by mechanical ventilation.

Preclinical studies indicate that LK-ICU preserves diaphragm muscle fiber size and function, which is critical for patients recovering from mechanical ventilation and could help reduce the duration of ICU-related complications as well mitigate the associated weaning costs.

Collaborating with the Medical University of Vienna, a leading institution in critical care, provides Leksum access to expert scientific and clinical planning, which is essential for the successful initiation and execution of the clinical trial for LK-ICU.

Before launching clinical trials, Leksum will engage in preparatory work that includes regulatory compliance, operational planning, and ethical considerations, alongside its CMC development partner, Phoenestra GmbH.