Saniona has started dosing in the SAN711 trial
Saniona has initiated dosing of the first subjects with SAN711 in a phase I multiple ascending dose biomarker study, aiming to release topline data by the end of the year. The CEO, Thomas Feldthus, see this as a milestone and a crucial step towards the goal of starting a clinical proof-of-concept study in children with absence seizures next year.
– This study with SAN711 in healthy volunteers offers valuable insights into the appropriate dosing for our phase II trial, helping to ensure positive outcomes.
Saniona’s drug candidate, SAN711, is phase II-ready and targets absence seizures, which are short lapses of consciousness. It has demonstrated effect in genetic animal models of absence seizures and a favourable safety profile in phase I clinical studies.
Preclinical data also suggests that SAN711’s selective pharmacology modulates specific brain circuits, which can be detected via EEG measurements during both awake and sleep 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 significantly impact the epilepsy treatment landscape, particularly for absence epilepsy, where patients can experience up to 200 seizures per day, severely affecting their quality of life. Current treatments often fail to adequately control absence seizures and can impair cognitive function, which underscores the urgent need for new treatment options.
Approved biomarker study
In September, regulatory authorities approved the initiation of a phase I multiple ascending dose (MAD)/biomarker study in adults with SAN711. This study is a key step towards launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. The company also plans to expand its use to first-line treatment and other forms of absence epilepsy.
First subjects dosed
Yesterday, Saniona announced the first dosed subjects in the phase I study. The study aims to investigate the effect of food intake on SAN711 dosing, 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. It will also gather data on food interactions and the drug’s pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers.
The study is conducted in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy.
In a comment to BioStock, Saniona’s CEO Thomas Feldthus says:
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.“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.”
