eClinical Technology and Industry News

Scribe Therapeutics Achieves Regulatory Clearance to Initiate First-in-Human Clinical Study of STX-1150 for LDL-C Reduction

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to extend healthy lifespan through disease prevention and durable therapeutic intervention, today announced that it has secured clearance from the Australian Therapeutic Goods Administration (TGA) to initiate a first-in-human clinical study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD).

Cardiovascular disease is the leading cause of death worldwide, with elevated low-density lipoprotein cholesterol (LDL-C) recognized as a key causal driver of atherosclerosis and ASCVD. Despite the availability of multiple lipid-lowering therapies, many patients remain above recommended LDL-C levels in real-world settings due to treatment burden, adherence challenges, delayed treatment initiation, and the need for ongoing chronic administration. STX-1150 is a novel, in vivo therapy designed to address these limitations by epigenetically silencing PCSK9, a genetically and clinically validated regulator of LDL-C, in the liver. Designed to deliver sustained LDL-C lowering after a single dose without permanently altering the underlying DNA, STX-1150 has the potential to support early and long-lasting ASCVD risk reduction for patients with elevated LDL-C and increased cardiovascular risk.

“Advancing STX-1150 into the clinic marks a pivotal moment for Scribe,” said Benjamin Oakes, Ph.D., co-founder and Chief Executive Officer of Scribe Therapeutics. “Years of iterative engineering to enhance the potency and specificity of our CRISPR technologies has culminated in our first clinical program designed to provide access to the effects of known cardioprotective genetics, potentially freeing patients from decades of treatment burden.

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