Initial Therapeutic Focus

Addressing Muscle Wasting in the ICU

Mechanical ventilation (MV) is a life-saving intervention, however

  • Prolonged MV leads to Ventilator Induced Lung Injury (VILI) and Ventilation Induced Diaphragmatic Dysfunction (VIDD), resulting in delayed and complicated weaning process, which is associated with higher mortality and morbidity rates1

~30% of the general ICU population develops Critical Illness Myopathy (CIM), a common neuro-muscular complication of ICU treatment

  • 100% of patients exposed to long-term controlled mechanical ventilation develop CIM

The cost of weaning ICU patients from MV exceeds $100 billion a year (mgt. est.) in the U.S. and Europe.

MV usage is also associated with other iatrogenic complications, including ventilator-associated brain injury (VABI).2

  • It can cause secondary brain injury in patients with established primary brain injury (i.e., stroke or traumatic brain injury) and can also be a primary cause of brain injury in patients without antecedent brain injury.
1/ MV typically results in more severe impact in older patients due to structural age-related changes in lung tissue. See here.
2/ For more information regarding VABI, readers may reference: Ventilator-associated Brain Injury: A New Priority for Research in Mechanical Ventilation.
Muscle Wasting in the ICU

Leksum believes the standard of care in ICUs will be for all patients who are anticipated to be mechanically ventilated for an extended period (i.e., more than a day or two) to be considered candidates to receive Leksum’s LK-ICU Protocol, which is currently defined as the administration of multiple doses of LK-ICU beginning the first day patients are put on mechanical ventilation and continuing every other day until no longer needed. This prophylactic intervention is expected to reduce (a) VILI, (b) muscle dysfunction including CIM and VIDD, both of which can result from VILI, and also (c) the risk of VABI. Our current hypothesis is that the lung injury induced by MV induces the release of factors which negatively affect muscle and brain function.

Market Size Estitmates of USE of MV in ICU
Disclaimer: The above estimates are provided for informational purposes only and include market and industry data which was obtained from publicly available sources believed by Leksum to be reliable. The information contained herein was gathered as of May 26, 2025, reflects present intention, is not complete, is subject to change without notice and is based on publicly available information, internally developed data and other sources, certain of which is dated. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information. Leksum disclaims and excludes all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way out of or in connection with the information in this forecast, its accuracy, completeness or by reason of reliance by any person on any of it. This estimates should not be construed as legal, financial or tax advice to any individual, as each individual’s circumstances are different. Readers should consult with their own professional advisors regarding their particular circumstances. Leksum has not independently verified any of the data from third-party sources referred to in this presentation or analyzed or verified the underlying reports relied upon or referred to by such sources, or ascertained the underlying assumptions relied upon by such sources. The Company does not make any representation as to the accuracy of such information.