Sonnet BioTherapeutics Holdings IncSONN announced that pharmacokinetic (PK) profile simulation of SON-1010 dosing had been completed in its Phase 1 trial in healthy volunteers.
The Safety Review Committee has found no significant safety concerns to date and has approved advancing to each higher dose level, the company said.
Typical dose-related increases were seen with SON-1010 after subcutaneous administration. Drug levels peaked at about 11 hours with a geometric mean maximum concentration (Cmax) of 29, 68, and 125 pg/mL for the 50, 100, and 150 ng/kg dose groups, respectively.
The mean elimination half-life (T½) after a 150 ng/kg dose of SON-1010 was 112 hours, compared to 12 hours for rhIL-12.
Observed increases in IFNg were most pronounced and were dose-related, controlled, and prolonged. SON-1010 induced IFNg in all active-drug subjects, which peaked at 24 to 48 hours and then returned to baseline after two weeks.
Low amounts of IL-10 were induced in a dose-dependent manner, which could also be due to the increase in IFNg. After dosing, there were small transient increases in IL-6, IL‑8, and TNFα, but no consistent pattern was seen. There was no evidence of cytokine release syndrome.
Price Action: SONN shares are down 8.80% at $1.1491 on the last check Thursday.
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