– This study with SAN711 in healthy volunteers offers valuable insights into the appropriate dosing for our phase II trial, helping to ensure positive outcomes.
Sanionas drug candidate SAN711 is ready for Phase II clinical trials and targets absence seizures, i.e. short-term cognitive absence episodes. The candidate has shown efficacy in genetic animal models of absence seizures and a favorable safety profile in Phase I clinical trials.
Preclinical data also suggest that SAN711's selective pharmacology modulates specific brain circuits, as detected by EEG measurements during both waking and sleeping states. This serves as a functional biomarker of SAN711's activity in the brain and may indicate potential benefits for patients in future studies.
According to Saniona, SAN711 has the potential to have a significant impact on the treatment landscape for epilepsy, particularly for absence epilepsy, where patients can experience up to 200 seizures per day, severely impacting quality of life. Current treatments often fail to adequately control absence seizures and can impair cognitive function, underscoring the urgent need for new treatment options.
Approved biomarker study
In September, regulatory authorities approved the start of a Phase I biomarker study in which adult participants will be given multiple escalating doses of SAN711. The study is an important step towards later conducting a proof-of-concept clinical study in children with absence seizures, which the company plans to start in 2025. The company also plans to expand the intended use to include first-line treatment and other forms of absence epilepsy.
The first subjects dosed
Yesterday, Saniona announced that the first subjects have been dosed in the Phase I study. The study aims to investigate how food intake affects dosing of SAN711, the safety and tolerability of higher doses, and the potential benefits using clinically relevant pharmacodynamic biomarkers.
The Phase I study will evaluate the safety, tolerability and pharmacokinetics of SAN711 at higher doses than those used in the previous Phase I study. Data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleeping states in healthy volunteers will also be collected.
The study is being conducted in collaboration with Evotec at the Clinical Research Centre (CRC) at the University Hospital in Verona, Italy.
In a comment to BioStock, Saniona's CEO says Thomas Feldthus:
"This study with SAN711 in healthy volunteers offers valuable insights into the appropriate dosing for our phase II trial, helping to ensure positive outcomes. Importantly, it may also validate preclinical biomarkers, providing evidence of brain circuit engagement, further proof of patient benefits, and potential clinical endpoints for future pivotal studies."