Saniona’s CEO comments on the recent news
Saniona is advancing its treatments for epilepsy and neurological disorders, with SAN2355 – a selective epilepsy therapy – now in GMP-manufacturing and toxicology studies, aiming for a clinical trial application by late 2025. Meanwhile, Saniona and Acadia Pharmaceuticals has completed two phase I MAD cohorts for ACP-711, formerly SAN711, confirming its safety in healthy volunteers. In addition, from March 18 to April 1, 2025, Saniona’s TO4 warrant program could raise up to SEK 188.4 million. We spoke with CEO Thomas Feldthus to learn more.
Epilepsy impacts millions globally, yet approximately 30 per cent of patients find no relief from existing treatments. Saniona’s SAN2355 seeks to bridge this gap. Unlike retigabine, a withdrawn Kv7 activator with side effects like urinary retention, or XEN1101, a phase III analogue with similar issues, SAN2355 selectively activates Kv7.2/Kv7.3 channels.
“This precise targeting reduces off-target effects, allowing for potentially higher, more effective doses”, Thomas Feldthus, CEO of Saniona said in a previous interview with BioStock. The drug, which has best-in-class potential, also shows promise results for severe pediatric epilepsies linked to Kv7.2/Kv7.3 mutations.
A selective advantage
Kv7 channels regulate potassium ion transport in neurons, preventing uncontrolled nerve impulses. Among the five subtypes (Kv7.1–Kv7.5), Kv7.2/Kv7.3 is the key target for anti-epileptic treatment, while activating other subtypes can cause severe side effects.
Non-selective activators activate other subtypes, causing adverse effects. SAN2355 avoids this pitfall by blocking Kv7.5 and sparing Kv7.1/Kv7.4. Unlike earlier drugs, SAN2355’s selectivity enhances safety and efficacy, Feldthus notes. This could improve outcomes for focal and generalized epilepsy, addressing a market with 600,000 difficult-to-treat patients alone in the US.
Development milestones with SAN2355
Last year, Saniona successfully completed analytical development, synthesis optimisation, and production of the GLP toxicology batch for SAN2355. The company anticipates finishing the remaining preclinical work in 2025. Building on this progress, Saniona has now taken another key step forward with the initiation of Good Manufacturing Practice (GMP) production, drug product formulation, and pharmacokinetic (PK) and Good Laboratory Practice (GLP) toxicology studies for SAN2355. The goal is to complete the data package for a clinical trial application by year-end.
With a potential U.S. market of 1.8 million focal seizure patients – 300,000 with severe refractory cases – SAN2355 could offer a safer alternative to current options if commercialised.
Capital raise via TO4 warrants
Saniona’s momentum continues with a planned capital raise through its TO4 warrant program, set for March 18 to April 1, 2025. For example, the program could generate between SEK 117.8 and 188.4 million at a subscription price of SEK 5.0–8.0 per share.
Building on recent successes – like the USD 610 million licensing deal with Acadia Pharmaceuticals, a USD 500,000 milestone payment from Boehringer Ingelheim, and up to EUR 9 million in seed funding for Cephagenix – this influx will support advancing SAN2355, SAN2219, SAN2465, and tesofensine’s regulatory push in Mexico. Read more here.
Progress with ACP-711 phase I study
While advancing SAN2355, Saniona has now also completed two cohorts in a phase I MAD study of ACP-711 (formerly SAN711) in healthy volunteers together with Acadia Pharmaceuticals. The study found ACP-711 safe and well-tolerated, with no serious adverse events, mild side effects, and no laboratory, cardiovascular, or neurological concerns. All participants completed the study. With essential tremor as the lead indication, the companies are seeking regulatory approval to extend testing to elderly volunteers and higher doses. The study is paused pending this approval.
Questions for CEO Thomas Feldthus
To learn more about the recent news and the TO4 warrant program, BioStock reached out to CEO Thomas Feldthus for a comment.
To start with, SAN2355 is moving forward. What is your comment on this milestone?
– We are planning to initiate preclinical development on three assets, SAN2219, SAN2355 and SAN2465 with the aim of preparing them for phase II clinical studies, thereby enhancing our strategic options. As an example, we could replicate the deal with Acadia in November on one of these programs and through the funding for such deal move the other two assets forward through proof of concept studies. SAN2355 is ahead of the other programs as we have already conducted the first part of the preclinical development in 2024. Therefore, I’m pleased that we now have initiated the second part thereby enabling us to finalize the data package by year end with the aim of starting phase I clinical studies.
What types of partnerships are you seeking for SAN2355’s development?
– We anticipate an worldwide licensing agreement with a pharmaceutical or biotech company.
What milestones do you anticipate reaching with the TO4 capital raise support?
– We have a very strong financial position and would not have made a financing like this now. Saniona has SEK 303 million in cash at year-end 2024. We anticipate that we will receive a milestone from Acadia of $10 million upon the start of phase 2 next year. In addition to this we have potential additional milestones from our research collaborations and potential royalties from tesofensine if it gets approval in Mexico. The proceeds from TO4 will strengthen our financial position and reduce the likelihood of having to do this type of financing in the future. Our intention is to become less dependent on the financial market and thereby avoid rights issue where options are granted free of charge.
What do the phase I MAD results for ACP-711 mean for the continued development?
– Apart from testing ACP-711 in higher doses, the phase I study also included a drug-food-interaction study and a biomarker study. I anticipate that Acadia will present these additional details at their R&D Day later. But we got what we were looking for in this study and ACP-711 is indeed a very well tolerated drug. When signing the deal with Acadia, we already agreed with them to expand the study with 1-2 cohorts in the elderly, because this is the key target population for Acadia in essential tremor. However, given the benign safety profile of ACP-711 in this study, Acadia and Saniona have now agreed to expand the additional cohorts with higher doses also.
The study has been temporarily paused until regulatory approval of the amendment to the ongoing phase 1 study. Can you comment on the timeline going forward?
– We agreed with Acadia to file an amendment to the study with the aim of testing ACP-711 in 1-2 additional cohorts in the elderly when we signed the deal. We will now also test ACP-711 in higher doses. This will not affect the overall timeline as this study is not on the critical path for start of phase II.
Also read: Saniona strengthened its cash position and advanced through partnership (February 28, 2025)
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.
