Saniona har genererat lovande prekliniska data med SAN711 i flera modeller av smärta och sällsynta neuropatiska störningar. BioStock kontaktade Rudolf Baumgartner, MD, Chief Medical Officer och Head of Clinical Development på Saniona, för att få veta mer om den fas I-säkerhetsstudie i friska frivilliga som nyligen påbörjades.

SAN711 är Boston-baserade Sanionas first-in-class positiva allosteriska modulator av GABAA α3-receptorer som tagits fram med bolagets proprietära plattform för läkemedelsupptäckt inom jonkanaler.

SAN711 förstärker selektivt effekterna av GABAA på receptorer som innehåller α3, i motsats till befintliga molekyler som riktar sig till alla receptorernas GABAA-underenheter. Bolagets prekliniska studier har indikerat att SAN711s selektivitet kan göra det möjligt för kandidaten att ge smärtlindring och andra fördelar i centrala nervsystemet, samtidigt som man undviker de typiska biverkningarna i samband med icke-selektiv GABAA-aktivering, såsom sedering, motorisk instabilitet, kognitiv försämring, risk för missbruk och fysiskt beroende.

CMO kommenterar

BioStock pratade med Rudolf Baumgartner, MD, Chief Medical Officer och Head of Clinical Development på Saniona, för att få hans syn på SAN711, som bolaget nyligen tog till fas I-studier.

Rudolf Baumgartner, this is the first trial in humans for SAN711. Why has Saniona selected SAN711 as the first program from its ion channel program to advance into the clinic?

– SAN711 is our most advanced compound from our proprietary ion channel drug discovery engine. It is what’s known as “first-in-class”, meaning that we designed it with a mechanism of action that is unique and different from mechanisms described for other molecules. SAN711 has already demonstrated efficacy in multiple preclinical models of neuropathic pain, so we are excited to have advanced it into human clinical trials.

Could you briefly explain to our readers how SAN711 works?

– SAN711 is a positive allosteric modulator of GABA-A α3 receptors. Essentially, GABA is a neurotransmitter, or chemical messenger, that blocks signals between nerve cells in the brain. Blocking these signals can result in sedation, pain relief, or seizure inhibition, among other effects. To function, GABA binds to its receptors, including various forms of GABA-A. SAN711 was designed to selectively enhance the effects of GABA-A on α3 containing receptors, which in preclinical studies resulted in pain relief and other benefits in the central nervous system while avoiding adverse effects such as sedation and cognitive impairment.

What are you hoping to see in this study, and what do you need to see to be confident that SAN711 can move forward into Phase II?

– The primary objective of the Phase 1 study is to determine the tolerability and the maximum tolerated dose of SAN711, and a secondary objective is to measure binding to target receptors. In this study, we will look to see that SAN711 is well tolerated at a therapeutic dose that we can move forward into Phase 2 and, in addition, we will look for confirmatory evidence that SAN711 is targeting the areas of the central nervous system that it is designed to target.

When will you select the indication for Phase II?

– The Phase 1 trial will be conducted in healthy adults, an indication for SAN711 will be finalized prior to Phase 2.

This study is being conducted in the UK – why did you choose the UK, and will you advance SAN711 in the US?

– Part of what is exciting about SAN711 is that it is highly targeted at the GABA α3 sub-receptor level, because of this we wanted to incorporate an analysis into our Phase 1 study that would confirm the compound is indeed reaching its desired target. We can achieve this using positron emission tomography (PET) technology. In the U.K., we were able to identify a hospital that has strong expertise in Phase 1 trials using PET scanning, so we felt this site would be ideal for this clinical trial. We do intend to submit an Investigational New Drug (IND) application to the U.S. FDA prior to Phase 2, so that we may conduct our Phase 2 trial in the U.S.

Finally, when do you expect to communicate results?

– Data from the SAN711 phase 1 trial are expected in the first half of 2022.

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