The primary objective of the phase I clinical study was to evaluate the safety, tolerability and pharmacokinetics of SGS518. The study was conducted among healthy volunteers in two cohorts, including a dose-ranging arm, followed by a multi-dose study. The conclusion of both arms of the phase I study found SGS518 to be safe and well tolerated.
“This was a first-in-man study with a new chemical entity and we are very pleased with the positive safety data obtained for SGS518,” said Dr Rodney Pearlman, president and CEO of Saegis. “These data provide valuable direction for our phase II clinical program.”
SGS518 is a selective antagonist of the 5-Hydroxytryptamine-6 (5-HT6) serotonin receptor believed to act by enhancing transmission of chemicals in the brain. While currently marketed drugs are often effective in treating the psychoses that characterizes schizophrenia, cognitive impairment associated with schizophrenia (CIAS) remains a significant unmet need, preventing controlled patients from leading normal lives.
SGS518 is the third compound under clinical evaluation by Saegis. The company’s lead compound, SGS742, is currently in phase II clinical studies for mild to moderate Alzheimer’s disease and a phase II study in adult ADHD.