Lilac–Soin pursue RNA biomarkers to objectify spinal cord stimulation pain; implications for Avidity Biosciences
- Robust RNA correlates could change how Avidity designs preclinical studies and clinical endpoints.
- RNA biomarkers could provide objective measures, speed translation and de-risk early human testing for Avidity.
- Validated RNA biomarkers could support Avidity's regulatory strategy, surrogate endpoints, and harmonized sampling across studies.
RNA readouts aim to objectify pain response
Lilac Biosciences is partnering with Soin Neuroscience to test whether changes in RNA expression can serve as reproducible molecular signatures of response to spinal cord stimulation, seeking to replace subjective pain reporting with objective biology. The collaboration uses preclinical neuromodulation models and large-animal spinal cord stimulation studies to measure transcripts tied to inflammation and neural signaling under defined stimulation parameters, waveforms and time courses. Lilac applies its quantitative RNA workflows to profile and validate data, while Soin aligns these experiments with its investigational next‑generation device systems.
Implications for RNA therapeutics developers such as Avidity Biosciences
If the collaboration identifies robust, reproducible RNA correlates of neuromodulation efficacy, it could reshape how companies in the RNA therapeutics and oligonucleotide field — including Avidity Biosciences — design preclinical studies and clinical endpoints. Molecular biomarkers that reflect tissue response to neuromodulation or pharmacologic intervention offer objective measures that can complement clinical scales, potentially speeding translational decisions and de‑risking early human testing. For firms developing RNA‑targeted modalities, such readouts could validate target engagement in relevant neural or inflammatory pathways and inform dosing, timing and combination strategies with devices.
The development of standardized, validated RNA biomarkers also affects regulatory strategy and device‑drug development models that companies like Avidity may pursue. Demonstrable, reproducible biomarkers can support regulatory discussions on surrogate endpoints, harmonize sampling protocols across studies and facilitate independent replication requirements. However, successful integration into product development depends on cross‑platform reproducibility, statistical validation and clear linkage between RNA changes and meaningful clinical benefit, all of which the Lilac–Soin collaboration frames as contingent milestones.
Collaboration details and scientific scope
The partnership sets milestones for standardized sampling, statistical validation and potential publication, with shared data, resources and intellectual property considerations. Work begins with defined preclinical models and is timed to Soin Neuroscience’s large‑animal spinal cord stimulation experiments, which test both clinically used waveforms and Soin’s investigational systems; the device is explicitly not FDA‑approved and is for research only.
Broader industry impact and next steps
Dr. Amol Soin says reproducible RNA signatures could guide next‑generation device design and provide objective endpoints that limit bias in future human studies. Initial data will determine whether RNA‑based readouts can serve as molecular biomarkers to inform device development, preclinical‑to‑clinical translation and more objective assessment of chronic pain therapies, with further human study designs contingent on robust validation and independent replication.