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Lokahi Therapeutics Inc, a wholly owned subsidiary of Glucotrack, Inc, has announced progress in its LT-100 development strategy focused on evaluating whether a historical administration approach requiring up to 15 intradermal (ID) injections per treatment visit can be simplified to a single subcutaneous (SC) injection per visit.
During a Type C meeting with the US Food and Drug Administration in May 2026, the company discussed its proposed clinical strategy for LT-100. Following that meeting, Lokahi completed a nonclinical minipig study designed to compare systemic exposure following subcutaneous and intradermal administration of LT-100. The results provided important information to support the company's planned clinical evaluation of a single-injection administration approach.
Building on the Type C meeting and the results of the nonclinical study, Lokahi is preparing for the next phase of LT-100 development, which is expected to include clinical evaluation of LT-100 administered as a single subcutaneous injection. Subject to completion of ongoing development activities and regulatory review, the company currently anticipates initiating clinical evaluation of this administration approach as early as the fourth quarter of 2026, with an initial readout potentially occurring during the first half of 2027.
Historically, in clinical trials, LT-100 has been administered through up to 15 intradermal injections per treatment visit. Lokahi's current development objective is to determine whether that administration approach can be simplified to a single subcutaneous injection while maintaining a development strategy informed by prior clinical experience.
"The difference between 15 injections and one injection speaks for itself," said Erik Emerson, chief executive officer of Lokahi Therapeutics. "The Type C meeting helped define a path forward. We then completed the work necessary to evaluate that path, and the results give us confidence to move toward clinical evaluation of this simplified administration strategy. Our focus now is preparing to test this approach in the clinic."
“Our objective was straightforward,” said Susan Kramer, senior vice president of development at Lokahi Therapeutics. “We wanted to understand whether subcutaneous administration could achieve systemic exposure consistent with prior clinical experience using intradermal administration. The study provided this and other important information to guide the next stage of LT-100 clinical development.”
Lokahi Therapeutics is a capital-efficient biopharmaceutical platform company focused on identifying, evaluating, acquiring, and advancing overlooked therapeutic assets. Through its ai² platform and ai² Futures Lab execution model, Lokahi integrates cross-functional expertise and disciplined decision-making to drive strategic development and long-term value creation.
Glucotrack Inc operates Lokahi and through its subsidiary Glucotrack Technologies Inc, is also focused on the design, development, and commercialization of novel technologies for people with diabetes, including a long-term implantable continuous blood glucose monitoring system. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use.
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