Saniona comments on the approval to initiate epilepsy study
Saniona has received approval to initiate a phase I multiple ascending dose and biomarker study in adults for SAN711, marking a key milestone toward a clinical proof-of-concept trial in children with absence seizures, planned for 2025.
– We are confident in its safety and believe it holds potential not only for this condition but for other epilepsy indications, and possibly beyond epilepsy, says CEO Thomas Feldthus.
Saniona’s main focus is progressing its pipeline of drug candidates targeting epilepsy and other neurological disorders. SAN711 is a phase II-ready candidate drug targeting absence seizures, while SAN2219 is being developed for the treatment of acute repetitive seizures. Lastly, SAN2355 addresses refractory focal-onset seizures.
In addition to its epilepsy programs, Saniona is working on four other initiatives. Tesofensine is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Furthermore, Tesomet is ready for phase IIb to treat rare eating disorders, while SAN903 is ready for phase I in inflammatory bowel disease. Lastly, SAN2465 is set for preclinical development and aims to treat major depressive disorder.
Targeting absence seizures with SAN711
According to Saniona, SAN711 has the potential to significantly impact the epilepsy treatment landscape, especially for absence epilepsy, where patients can suffer up to 200 attacks per day, greatly affecting their quality of life. Current treatments, including older drugs like ethosuximide and valproate, often fail to control absence seizures adequately and can impair cognitive function. Despite a pressing need for better treatments, there has been little innovation in this area for more than half a century, and broad-spectrum antiseizure medications often prove ineffective or have serious side effects.
SAN711 presents a novel approach, demonstrating effectiveness in genetic animal models of absence seizures and showing a favorable safety profile in phase I clinical studies. Saniona plans to initially focus on patients with childhood absence seizures who are resistant to existing therapies, to eventually expand its use to first-line treatment and other forms of absence epilepsy.
Approved biomarker study with SAN711
In June, Saniona filed a Clinical Trial Application (CTA) for a phase I multiple ascending dose (MAD)/biomarker study in adults for SAN711. This study will lay the foundation for a clinical proof-of-concept study in children with absence seizures, which could start next spring. The application has now been approved.
The dosing could begin shortly
Saniona is conducting this study in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. The parties and Saniona expect to begin dosing patients within the next few weeks. Additionally, Saniona is conducting a preclinical juvenile toxicity study and physiologically based pharmacokinetic modelling to translate the adult phase I data into appropriate dosing for children.
Comments from the CEO
Thomas, can you discuss the key aims of the study?
– The study will explore three key aspects to inform future clinical trials: the impact of food intake on SAN711 dosing, the potential benefits of higher doses, and the validation of functional biomarkers for SAN711.
The study’s timeline is short. When do you expect to share the first data?
– We anticipate reporting topline data by the end of 2024.
What are the next steps following this initial study?
– The next step is to test SAN711 in patients to establish proof of concept for treating childhood absence seizures. We are confident in its safety and believe it holds potential not only for this condition but for other epilepsy indications, and possibly beyond epilepsy. SAN711, a highly selective positive allosteric modulator of GABA receptors, has shown a strong safety profile and is likely the best-tolerated drug candidate of its kind tested in clinical trials so far. The prior phase I study demonstrated excellent tolerability and high receptor occupancy, which is expected to deliver the therapeutic benefits we seek. This new study will validate findings from our preclinical work and refine dosing for patients.
What are your expectations for the next six months regarding collaborations and clinical progress?
– We aim to complete the current SAN711 study and prepare for the proof-of-concept trial. We also plan to finalize the toxicology batch for SAN2355, positioning us for a phase I study next autumn, pending funding. We are actively pursuing collaborations for three different assets and aim to secure at least one this year. Additionally, we await regulatory approval for tesofensine in Mexico, which, based on a solid safety profile and positive phase III results for obesity, could open new revenue streams and expand into other markets.
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