Saniona’s primary focus is developing 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 has been chosen from the company’s Kv7 Program to address focal onset seizures.
Progress with SAN2355
Saniona selected SAN2355 as the first clinical candidate from its Kv7 epilepsy program late last year. Having successfully passed critical candidate selection steps and secured a favourable opinion from the European Patent Office, Saniona started to advance SAN2355 into preclinical development. The company see potential for SAN2355 to become best-in-class in the hyped Kv7 activators for epilepsy.
This week, Saniona announced significant progress in the preclinical development of SAN2355. The company has identified a stable solid form of the compound and completed synthesis optimization, enabling a robust, scalable manufacturing process. As a result, the company has successfully produced 4 kg of SAN2355 for GLP toxicology studies. The project is now ready for preclinical toxicity and safety studies, in compliance with GLP standards.
”Its potential to outperform existing treatments and capture a significant portion of this underserved market makes SAN2355 a highly promising candidate for commercialization.” – Thomas Feldthus, vd Saniona
Comments from the CEO
BioStock contacted CEO Thomas Feldthus to delve into these news.
Thomas, what are the potential advantages of SAN2355’s selectivity profile compared to previous Kv7 activators like retigabine?
– SAN2355 is uniquely selective for the Kv7.2/Kv7.3 subunits, key targets for treating epilepsy. Unlike earlier non-selective drugs like retigabine, which activated other subunits such as Kv7.4 and Kv7.5, leading to side effects like urinary retention and tremors and other CNS side effects, SAN2355’s precise targeting reduces the risk of these off-target effects. This selectivity allows for potentially higher, more effective doses without compromising safety, thus improving both efficacy and patient outcomes.
After completing synthesis optimization and GLP toxicology batch production, what are the next key milestones for SAN2355?
– Following the successful completion of synthesis optimization and the production of GLP toxicology batches, the next key milestones for SAN2355 include completing preclinical toxicity and safety studies over the next nine months. Pending successful results and funding, SAN2355 may begin Phase 1 clinical trials in Q3 2025.
How can SAN2355 address unmet needs in the epilepsy market, particularly for patients unresponsive to existing treatments?
– Approximately 30% of epilepsy patients are unresponsive to current anti-seizure medications, underscoring the significant need for new treatments. SAN2355’s mechanism of selectively activating Kv7.2/Kv7.3 channels offers a novel approach that could be especially beneficial for patients with difficult-to-control or refractory epilepsy. By avoiding activation of subunits that may cause side effects or exacerbate seizures, SAN2355 has the potential to fill this gap and provide a safer, more effective option for these patients.
Are there any planned partnerships or collaborations to support SAN2355’s clinical development?
– We remain open to exploring additional partnerships to support SAN2355’s clinical development and commercialization efforts. Strategic collaborations could accelerate clinical trials, expand market reach, and ensure a smooth path to regulatory approval.
What are the market opportunities for SAN2355 if it successfully reaches commercialization?
– The focal onset seizure market represents a substantial opportunity, with around 1.8 million adults affected in the U.S. Although 900,000 are well-managed with existing treatments, approximately 600,000 are difficult-to-treat patients, and 300,000 have severe refractory epilepsy. SAN2355, with its selective activation of Kv7.2/Kv7.3, could address this unmet need by offering a safer and more effective alternative to non-selective Kv7 activators. Its potential to outperform existing treatments and capture a significant portion of this underserved market makes SAN2355 a highly promising candidate for commercialization.
