- 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.
Sanionas The main focus is to develop its pipeline of drug candidates targeting epilepsy and other neurological diseases. SAN711 is a Phase II-ready drug candidate that targets absenteeism, while SAN2219 is being developed for the treatment of acute repetitive seizures. Finally, it is aimed SAN2355 against refractory focal seizures.
In addition to its epilepsy programs, Saniona is working on four other development tracks. Tesofensine is on track for regulatory approval for the treatment of obesity in Mexico through a partnership with MedixFurthermore, Thesomet ready for a Phase IIb study for the treatment of rare eating disorders, while SAN903 is ready for Phase I in inflammatory bowel disease. Finally, SAN2465 is ready for preclinical development for major depressive disorder.
Treatment of absence seizures with SAN711
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 suffer up to 200 seizures per day, greatly impacting their quality of life. Current treatments include older drugs such as ethosuximide and valproate and often fail to adequately control absence seizures and can impair cognitive function. Despite an urgent need for better treatments, innovation in this area has stagnated for more than half a century. Broad-spectrum antiepileptic drugs are often ineffective or lead to serious side effects, underscoring the need for new treatments.
SAN711 is a novel treatment that has demonstrated efficacy in genetic animal models of absence seizures and has demonstrated a favorable safety profile in Phase I clinical trials. Saniona plans to initially focus on pediatric absence seizures resistant to existing treatments, with the goal of expanding its use to first-line treatment and other forms of absence epilepsy.
Approved biomarker study with SAN711
In June, Saniona submitted 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 proof-of-concept clinical study in children with absence seizures, which is expected to start next spring. The application for the MAD study has now been approved.
Dosing can begin shortly
Saniona is conducting the study in collaboration with Evotec at the Clinical Research Center (CRC) at the university hospital in Verona, Italy. It is expected to be able to start dosing patients within the next few weeks. Saniona is also conducting a preclinical toxicity study in adolescents and physiologically based pharmacokinetic modeling to translate Phase I data in adults into appropriate doses for children.
Comments from the CEO
BioStock spoke with the CEO Thomas Feldthus to get an overview of the company's ongoing activities.
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.