Saniona is currently advancing its epilepsy assets to provide clinical proof-of-concept for SAN711 and preparing SAN2355 for phase I. Meanwhile, the company is anticipating the approval of tesofensine in Mexico this year, while scouting for yet more partnerships. BioStock spoke with the company’s CEO to learn more.
– We see interest in several of our assets and have several exciting leads to pursue. We have weekly meetings with potential partners and open data rooms for new companies every month. I’m confident that we will succeed, says Thomas Feldthus.

Saniona’s drug development platform revolves around the modulation of ion channels in the brain – proteins that play a major role in signal transmission between brain cells.

The company has four clinical programmes aimed at collaboration. Tesomet is ready for phase IIb targeting rare eating disorders, SAN903 is ready for phase I in inflammatory bowel disease, while SAN2465 is set for preclinical development for major depressive disorder.

Last, but certainly not least, Tesofensine is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Saniona recently provided additional data to support the approval process and is hoping for a positive decision later this year.

With a strong efficacy and safety profile, and a potential approval in Mexico this year, tesofensine could address a significant medical need and generate new revenue streams for Saniona, — Saniona’s CEO Thomas Feldthus in the 2024 Q1 report

Clinical biomarker studies with SAN711

Saniona’s epilepsy pipeline features SAN2355 – a best-in-class and new generation of Kv7.2/Kv7.3 activators for the treatment of focal onset seizures. It also features SAN2219 for acute repetitive seizures and SAN711, a phase II-ready candidate drug targeting absence seizures.

Saniona has launched a comprehensive development plan for SAN711, which includes a phase I/biomarker study in adults, a juvenile toxicity study, and physiologically based pharmacokinetic (PBPK) modelling in 2024. This will precede a clinical proof-of-concept study for absence seizures in paediatric patients, scheduled for spring 2025.

Progress with SAN2355

Saniona has also initiated preclinical development of SAN2355 and identifying a scalable process and a stable drug substance suitable for both clinical trials and commercial use.

With a scalable process and stable drug substance, the company anticipates completing manufacturing this year, aligning with standard preclinical development timelines.

Potential revenue from collaborations

A core part of Saniona´s business strategy is to forge partnerships to yield future revenue streams. The collaborations with AstronauTx and Boehringer Ingelheim are prime examples where Saniona has previously excelled in this regard.

The partnership with AstronauTx aims to explore novel treatments for Alzheimer’s disease and other neurodegenerative diseases by targeting an undisclosed ion channel. This collaboration could yield up to SEK 1.9 billion (USD 177 million) in milestone payments and royalties. Read more here.

Meanwhile, the collaboration with Boehringer Ingelheim aims to uncover schizophrenia treatments. This collaboration alone could bring in EUR 76.5 million in milestone payments and royalties on worldwide net sales of resulting products.

Finally, Saniona’s partner Medix holds an exclusive license to commercialize the obesity treatment tesofensine in Mexico and Argentina, while Saniona is entitled to milestone payments and royalties on product sales. Saniona retains commercial rights in the rest of the world and rights to use any data generated from the successful phase III trial.

Comments from the CEO

BioStock caught up with Saniona’s CEO Thomas Feldthus to get insights into the progress with SAN711 and SAN2355 and the process of cultivating new partnerships.

To start out with Thomas, what are your long-term expectations for tesofensine?

– In February 2023 the advisory board to the regulatory agency in Mexico issued a favourable opinion about the use of tesofensine for obesity.

– Medix has subsequently filed a formal application in May last year and have since then been in regular contact with the agency.

– The application comprises a long document. Tesofensine has been tested in about 1,600 patients in 26 different clinical trials over two decades in various geographies and by different companies. All this information has been organized and filed to the agency in Mexico. I’m told that the documents comprise around 20,000 pages. So, it takes some time to digest.

– The regulatory agency has been studying this application carefully and has dug into all the details.

– They have of course questions, and they may need some additional information and documentation from Medix or Saniona. In 2024, we have been more and more involved in this process. It appears to me that Medix has provided good answers to the requested information.

– Obviously, new questions may come up, which need to be addressed. But we are getting closer to a potential approval. It’s not possible to give a time estimate for this. However, I’m cautiously optimistic about the potential for a regulatory approval this year.

– If successful, this will have major impact on Saniona. It will be our first product on the market, and it could secure stable income through mid-teens royalties over the next several years. Furthermore, we think that this will provide significant opportunities for introduction of tesofensine in other markets in the coming years.

Can you discuss the importance of the progress made in recent months with SAN711 and SAN2355?

–  I’m glad that we now have funding to develop our clinical and preclinical assets within epilepsy. In 2024, we will conduct a biomarker study on SAN711 in healthy volunteers, and preclinical work to allow treatment in children. These efforts will enable us to start a proof-of-concept study in children early next year. In addition to this, we have initiated preclinical development of SAN2355, the K7 programme. We have made significant progress and hope to have tox batch ready for GLP studies during the second half of this year. This means that we potentially can make this programme ready for phase I clinical studies in 2025.

– I believe that this could generate significant value for shareholders. Proof-of-concept for SAN711 in children for absence seizures would obviously create a lot of value. Making SAN2355 ready for phase I clinical trials will also create a lot of value given that SAN2355 has the potential to become best-in-class among compounds where financial analysts have put a price tag of USD 1 billion on a phase I programme.

–  This could lead to a very nice exit in a couple of years, if this is the preferred route for Saniona at that time.

Besides these advancements, securing new partnerships remains a key goal. Could you provide an update on the current status in this regard?

–  We see interest in several of our assets and have several exciting leads to pursue. We have weekly meetings with potential partners and open data rooms for new companies every month. I’m confident that we will succeed.

What significance do partnerships play for Saniona?

– Partnerships are a cornerstone for our strategy as it validates our assets and technology and provides funding to support our own clinical development activities.

There have been some setbacks in forming new partnerships. What specific measures is Saniona taking to mitigate these risks in future negotiations?

– We made a new research collaboration with AstronauTx for Alzheimer’s disease in July last year. Our objective was to make one more collaboration in 2023. I expected also to close the other deal last summer. But bad things may happen even at a very late stage during negotiations.

– We have tried this several times over the last 12 months. Some discussions have been paused or terminated because our potential partner had a significant setback on an important pipeline programme leading to a change in their in-licensing strategy. Other discussions have been paused or terminated because our potential partner suddenly got very concerned about a generic risk. All programmes are associated with generic risks in our industry, and it has nothing to do with Saniona or our programmes if the discussions are put on hold because our partner experiences an unforeseen disruptive event.

– We are mitigating this risk by working on several partnerships in parallel. Sooner or later, we will succeed.

Looking ahead to 2025 and beyond, what are the primary challenges Saniona anticipates, and how are you preparing to address them to ensure sustained growth and innovation?

– We have a very effective research platform, which has generated two new drug candidates last year. Both have in my view blockbuster potential. I’m confident that our current team and our platform will be able to sustain our innovation power.

– The setback in the financial market for biotech companies represents the biggest challenge for biotech companies today. I have been through several of these crises. Nobody can tell when the – current situation changes.

– We are working on making us less dependent on the financial markets through our partnering activities and through our support to Medix for obtaining regulatory approval for tesofensine in Mexico.

– The agenda for 2024 is to: 1) make new partnerships, 2) support Medix for approval of tesofensine in Mexico, and 3) start implementing our epilepsy strategy and increase the value of two of our candidates by moving them forward in development.

– Income from partnerships will be used to continue the development of our epilepsy assets. The potential approval and launch of tesofensine could spark a tremendous growth opportunity, which may drive the company’s equity story and provide funding for our epilepsy strategy and other assets for several years. Until then partnerships will remain a cornerstone in our business strategy.

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