Saniona har kommunicerat viktiga prekliniska framsteg i utvecklingen av läkemedelskandidaten mot epilepsi SAN2355, för behandling av fokala anfall. BioStock kontaktade vd Thomas Feldthus för att få veta mer.

Sanionas primära fokus är att utveckla sin pipeline av läkemedelskandidater som riktar sig mot epilepsi och andra neurologiska sjukdomar. SAN711 är en fas II-klar läkemedelskandidat som riktar sig mot absenser, medan SAN2219 utvecklas för behandling av akuta repetitiva anfall. Slutligen har SAN2355 valts ut från bolagets Kv7-program, för behandling av fokala anfall.

Framsteg med SAN2355

Saniona valde SAN2355 som den första kliniska kandidaten från sitt Kv7-epilepsiprogram i slutet av förra året. Efter att framgångsrikt ha klarat de kritiska stegen för urval av kandidater och säkrat ett positivt utlåtande från det europeiska patentverket, inledde Saniona preklinisk utveckling med SAN2355. Bolaget ser att SAN2355 har potential att bli “best-in-class” inom det hypade området Kv7-aktiverare för behandling av epilepsi.

I veckan meddelades betydande framsteg i den prekliniska utvecklingen. Saniona har identifierat en stabil fast form av substansen och slutfört syntesoptimeringen, vilket möjliggör en robust och skalbar tillverkningsprocess. Bolaget har producerat 4 kg SAN2355 för GLP-toxikologistudier, vilket gör att projektet är redo för prekliniska toxicitets- och säkerhetsstudier, i enlighet med GLP-standarden.

”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

Vd kommenterar

BioStock kontaktade vd Thomas Feldthus för att få veta mer om dessa nyheter.

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.

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