$GCTKJul 29, 2026, 9:30 PMAI processed
GCTK: Lōkahi advances LT-100 toward single‐injection subcutaneous dosing
AI Summary
Lōkahi (Glucotrack ticker GCTK) said an FDA Type C meeting and a nonclinical minipig study comparing systemic exposure after subcutaneous (SC) vs intradermal (ID) dosing support a development push to replace up to 15 ID injections with one SC injection. The company expects to begin clinical evaluation as early as Q4 2026 with a potential initial readout in H1 2027, subject to ongoing development activities and regulatory review.
Positives
- FDA Type C meeting identified a path forward for changing administration from multiple ID injections to a single SC injection
- Nonclinical minipig study reportedly showed SC systemic exposure consistent enough with prior ID data to justify clinical testing
- Company targets starting clinical evaluation in Q4 2026 with a potential initial readout in H1 2027
Negatives
- Current supportive data are nonclinical (minipig) and not yet validated in humans
- Advancement to clinical testing is contingent on completion of development activities and regulatory review, so timelines are not guaranteed
- Press release provides no quantitative exposure data or study size details to assess strength of the nonclinical signal