Saniona avancerar för närvarande sina epilepsitillgångar för att tillhandahålla kliniskt proof-of-concept för SAN711 och förbereda SAN2355 för fas I. Samtidigt hoppas bolaget att tesofensine ska godkännas i Mexiko i år, parallellt som man letar efter fler partnerskap. BioStock pratade med bolagets vd för att få veta mer.
– Vi ser intresse för flera av våra tillgångar och har flera spännande spår att driva. Vi har möten varje vecka med potentiella partners och öppnar datarum för nya bolag varje månad. Jag är övertygad om att vi kommer att lyckas, säger Thomas Feldthus.

Sanionas läkemedelsutvecklingsplattform kretsar kring modulering av jonkanaler i hjärnan – proteiner som spelar en viktig roll i signalöverföringen mellan hjärnceller.

Bolaget har fyra kliniska program som är redo för samarbeten. Tesomet är redo för fas IIb i sällsynta ätstörningar, SAN903 är redo för fas I i inflammatorisk tarmsjukdom medan SAN2465 är redo för preklinisk utveckling för egentlig depression.

Sist, men absolut inte minst, närmar sig tesofensine regulatoriskt godkännande för fetma i Mexiko genom ett partnerskap med Medix. Saniona tillhandahöll nyligen ytterligare data för att stödja godkännandeprocessen och hoppas på ett positivt beslut senare i år.

Med en stark effekt- och säkerhetsprofil, och ett potentiellt godkännande i Mexiko i år, kan tesofensine tillgodose ett betydande medicinskt behov och generera nya intäktsströmmar för Saniona. – vd Thomas Feldthus i Q1-rapporten

Kliniska biomarkörstudier med SAN711 under Q4 inför proof of concept-studie 2025

Sanionas epilepsipipeline innehåller SAN2355 – en ny generation av Kv7.2/Kv7.3-aktivatorer för behandling av fokala anfall. Den innehåller också SAN2219 för akuta repetitiva anfall och SAN711, en fas II-klar läkemedelskandidat som riktar sig mot absenser.

Saniona har lanserat en omfattande utvecklingsplan för SAN711, som inkluderar en fas I/biomarkörstudie på vuxna, en toxicitetsstudie i unga och fysiologiskt baserad farmakokinetisk (PBPK) modellering under 2024. Detta kommer att föregå en klinisk proof of concept-studie för abstinensanfall hos pediatriska patienter, planerad till våren 2025.

Framsteg med SAN2355

Saniona har också inlett preklinisk utveckling av SAN2355 och identifiering av en skalbar process och en stabil läkemedelssubstans som lämpar sig för både kliniska prövningar och kommersiell användning. Med en skalbar process och en stabil läkemedelssubstans räknar bolaget med att slutföra tillverkningen i år, i enlighet med standardtidslinjer för preklinisk utveckling.

Potentiella intäkter från samarbeten

En central del av Sanionas affärsstrategi är att skapa partnerskap för att skapa framtida intäktsströmmar. Samarbetena med AstronauTx och Boehringer Ingelheim är utmärkta exempel där Saniona tidigare har utmärkt sig i detta avseende.

Partnerskapet med AstronauTx syftar till att utforska nya behandlingar för Alzheimers sjukdom och andra neurodegenerativa sjukdomar genom att rikta in sig på en ej kommunicerad jonkanal. Samarbetet kan ge upp till 1,9 miljarder kronor (177 miljoner USD) i milstolpsbetalningar och royalties. Läs mer här.

Samarbetet med Boehringer Ingelheim syftar till att ta fram nya behandlingar för schizofreni. Enbart detta samarbete skulle kunna inbringa 76,5 miljoner euro i milstolpsbetalningar och royalties på den globala nettoförsäljningen av resulterande produkter.

Slutligen har Sanionas partner Medix en exklusiv licens att kommersialisera fetmabehandlingen tesofensine i Mexiko och Argentina, medan Saniona har rätt till milstolpsbetalningar och royalties på produktförsäljningen. Saniona har behållit de kommersiella rättigheterna i resten av världen och rätten att använda data från den framgångsrika fas III-studien.

Vd kommenterar

BioStock kontaktade Thomas Feldthus för att få en inblick i framstegen med SAN711 och SAN2355 och processen med att främja nya partnerskap.

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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