US-based biotechnology company Seismic Therapeutic has dosed the initial cohort of healthy participants in a randomised Phase I trial of S-1117, a treatment for autoimmune diseases.
The double-blind, placebo-controlled trial aims to evaluate the drug’s pharmacodynamics, tolerability, pharmacokinetics and safety in healthy individuals.
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It will also measure key pharmacodynamic markers such as the depth and speed of IgG minimisation and the B-cell receptor cleavage on memory B cells.
The trial will be conducted in two segments, starting with a single ascending dose stage before progressing to a multiple ascending dose stage.
Seismic Therapeutic’s aim is to utilise S-1117 as part of a ‘treat-to-target’ strategy, with the aim to enable customised treatment based on individual disease activity.
S‑1117 has demonstrated biological activity in several in-vivo models, suggesting the potential for treating both chronic and acute IgG autoantibody-driven conditions.
These include myasthaenia gravis, chronic inflammatory demyelinating polyneuropathy and immune thrombocytopaenia.
Seismic Therapeutic plans to test the drug’s efficacy as a chronic and acute treatment for these conditions.
Developed using the company’s IMPACT platform, S-1117 is designed to selectively cleave IgG and exhibit improved drug-like properties.
It addresses multiple pathogenic mechanisms in a single molecule, potentially leading to superior clinical outcomes in a range of autoimmune disorders.
Seismic Therapeutic CEO Jo Viney said: “The start of our first-in-human study of S‑1117 marks a significant milestone for Seismic as we transition to a clinical-stage company.
“S‑1117 validates our founding belief that we have the potential to create transformative medicines by leveraging machine learning through our IMPACT platform, guided by the best minds in immunology to discover novel biologics.”
Based in Massachusetts, Seismic Therapeutic develops biologics for autoimmune diseases using its integrated IMPACT platform, which is designed for controlling dysregulated adaptive immunity.
The company is supported by various investors from across the life sciences sector.
