Scribe Therapeutics has secured clearance from Australia’s Therapeutic Goods Administration to initiate a first-in-human clinical study of STX-1150 for hypercholesterolemia.
The Phase 1, open-label study is planned as a single ascending dose phase followed by a dose expansion, with planned enrollment of up to 64 participants across sites in Australia and New Zealand, and the objectives are to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics.
STX-1150 is an investigational, liver-targeted epigenetic silencing therapy designed to durably reduce low-density lipoprotein cholesterol by silencing transcription of PCSK9; the therapy, according to the company, uses its ELXR platform to achieve sustained target suppression without inducing permanent DNA changes.
Monash University’s Victorian Heart Hospital has been identified as the first global trial site to begin testing STX-1150.
The company claims preclinical data in non-human primates showed greater than 50 percent reductions in LDL-C sustained for approximately 18 months following a single administration at doses below 1.0 mg per kilogram. The trial is intended to generate initial human safety and pharmacodynamic data to support further development.
