Hoth Therapeutics (HOTH) announced combined positive findings from multiple preclinical programs evaluating its precision antisense candidate HT-KIT, including anti-tumor efficacy, a clean safety profile, and new GLP-validated bioanalytical results that exceeded internationally recognized regulatory thresholds. The study demonstrated that HT-KIT meets or exceeds the following bioanalytical benchmarks: regulatory-grade validation: all calibration curve, quality control, and dilution integrity requirements passed with high reproducibility; data integrity: 90.5% of Incurred Sample Reanalysis values fell within +/-30%, well above the 66.7% regulatory minimum; extended stability: HT-KIT remained stable in serum for 37 days at -80 degrees C, surpassing the validated 28-day stability period, with further studies ongoing; no protocol or SOP deviations impacted study reliability. Hoth expects to integrate this bioanalytical data into its formal GLP toxicology package and is preparing for an IND.
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