Efter ett 2022 med både upp- och nedgångar är Saniona fullt fokuserat på utveckling av sin pipeline och partnerskapsdiskussioner. BioStock kontaktade vd Thomas Feldthus för att få veta mer om ambitionerna för partnerskap under 2023.

I slutet av mars 2022 meddelade Sanionas dåvarande amerikanska ledning att bolaget, på grund av begränsade finansiella resurser, inlett en frivillig paus av de två kliniska fas IIb-studierna med Tesomet. Marknaden reagerade negativt på beskedet och aktien rasade med cirka 60 procent under en tumultartad vecka.

Ansträngningarna har gett resultat

För att komma tillbaka på rätt spår genomförde Saniona en stor omstrukturering med en förändring av ledningen, en nedläggning av all amerikansk verksamhet och en uppsägning av alla anställda i USA. Bolagets medgrundare och tidigare CFO, Thomas Feldthus, valdes till ny vd och en ny strategi för att bygga långsiktigt värde från bolagets jonkanalplattform och pipeline tog form.

Marknadens förtroende för bolaget ökade successivt under 2022 och ännu mer under 2023, där aktien tagit fart stadigt med över 40 procent. Vad är då bakgrunden till denna utveckling?

Vd kommenterar framstegen och blickar framåt

BioStock kontaktade vd Thomas Feldthus för att få veta mer om den senaste tidens framsteg i bolaget och om partnerskapsambitionerna för 2023.

Saniona had a strong focus on restructuring of operations during last year, but also on development of the pipeline. For instance, you have made significant progress on the phase 1 asset SAN711.

– Yes, that is correct. In June, we reported the successful completion of our phase 1 clinical trial for SAN711. The study demonstrated that SAN711 was safe and well tolerated and that it was possible to obtain high 24-hour exposure levels corresponding to expected desired therapeutic effect at a well-tolerated dose. It is probably the most well tolerated GABAA modulator developed to date. This is important as it makes us the first company in the world to evaluate a very promising GABAA α3 concept for effective and tolerable pain management in severely impacted neuropathic patient populations.

– It may also potentially be relevant in various types of epilepsies, including absence seizures and rare epileptic syndromes. Given the data and potential, I see SAN711 as a potential lead program for Saniona, as it fits very well into our pipeline and strategy. Therefore, we have been and are preparing clinical development plans, which we can execute on when funding becomes available. The program could also be an attractive candidate for partnering and we will consider potential options in this direction also. In fact, we are currently engaged in constructive discussions with several potential partners for different products, which I will elaborate on a bit later.

You also made progress in the SAN903 program that is positioned for inflammatory bowel disease?

– That is true. In November we announced that SAN903 was ready to start the regulatory process for entering phase 1 clinical trials. As is the case with SAN711, this program would also be suitable for a partnership development. The candidate has the potential to be the first maintenance drug with independent actions on both acute inflammation and chronic fibrotic complications. This is highly relevant in inflammatory bowel disease, as many of these patients experience repeated episodes of acute inflammation leading to progressed intestinal fibrosis that ultimately requires surgical intervention to resolve potentially life-threatening gut obstructions.

– There are several products available and in the clinical pipeline for the management of inflammation in IBD. But there is not much available for fibrosis and is where we see the significant medical need in IBD. As opposed to inflammation, which goes up and down, fibrosis is a non-reversible process which continues at slow pace throughout the disease and typically increases during inflammatory flair-ups. The fibrosis results in strictures and obstructions in the intestines and requires surgery. SAN903 is truly unique as it may suppress both inflammation and fibrosis. Therefore, it may potential be used for both maintenance therapy and during inflammatory flair-ups to reduce fibrosis.

Later in 2022, SAN2219 was selected as the first preclinical development candidate from your GABAA α2/α3 activator program. What is the aim of this candidate?

– SAN2219 has demonstrated highly encouraging efficacy in several in vivo seizure models and has the potential to fulfil important unmet medical needs within epilepsy with strong seizure control, high tolerability, and low potential for tachyphylaxis, that is, loss of effect. We see potential for SAN2219 within common epilepsies such as focal epilepsy as well as rare epileptic syndromes.

You also made progress in the Kv7 ion channel epilepsy program into lead optimisation phase, the last drug discovery phase before potential drug candidate selection?

– As of today, no drugs of this class are on the market targeting epilepsy, although the fact is that Kv7 modulation is a clinically and commercially proven concept for treatment of this indication. There is an increasing number of mutations in Kv7.2 and Kv7.3 channel subtypes that are found to be associated with severe inherited forms of epilepsy. Thus, we see a significant potential for delivering new breakthrough epilepsy treatments in this field.

During 2022, Saniona also made progress within the existing partnership program with Boehringer Ingelheim and in 2023 with Cephagenix. Can you give us a brief recap?

– During the last year, our ongoing ion channel research collaboration for schizophrenia with Boehringer Ingelheim advanced to the ‘hit-to-lead’ stage. This collaboration is focused on a novel, undisclosed CNS ion channel target. We are receiving ongoing research funding and may receive up to 76.5 million Euro in milestone payments as well as royalties on worldwide net sales.

– Regarding the Cephagenix joint venture program we were able to communicate successful preclinical in vivo validation in January 2023. This collaboration is aimed at identifying subtype-selective ATP-sensitive potassium channel (KATP) inhibitors for the treatment of migraine. We have identified the first generation of novel highly selective inhibitors of the specific KATP channel subtype expressed in the intracranial arteries and demonstrated that these compounds are effective in relevant in vivo animal models.

– One of the problems within migraine is that the  response rates for the available therapies are typically low and most patients are not treated with prescription medicines for this invalidating disease. The Cephagenix concept represents a new effective and safe treatment option, which may address broad patient populations since it is based on unifying mechanism in migraine.

What is the status in the two Tesomet programmes?

– We have shown very promising clinical results within these two programs for the treatment of the serious rare diseases, Prader-Willi syndrome (PWS) and hypothalamic obesity (HO). Tesomet is well positioned for partnering. We are developing a plan for internal development within HO if we do not partner this program and decide to progress it ourselves.

Recently, the Mexican regulatory authority technical committee on new molecules provided a favourable opinion on your drug candidate tesofensine for the treatment of obesity. Any comments on this?

– We were obviously very excited about the prospect of Medix potentially being able to launch this product this year. This is what it the biotech and pharma industry is all about: getting a new product on the market to resolve a significant medical need for the benefit of patients. This may also provide a stable income to Saniona in the coming years. However, I would like to stress that the authorities have yet to make a final decision. The technical committee has provided a favorable opinion for approval. Although the regulatory agency is expected to follow the recommendation, there is no guarantee that they will do so. I recommend your readers to read my latest interview with BioStock (here).

Last week, The World Obesity Federation, a partner to the WHO, released a report that concluded that the economic impact of overweight and obesity will surpass 4 trillion USD by 2035. Your comments?

– Unfortunately, this development continues to go in the wrong direction. Already in 2015, the McKinsey Global Institute (MGI) reported that 2.1 billion people – 30% of the global population – were overweight or obese resulting in economic impact of about $2 trillion a year, which made the burden of obesity equivalent to the economic damage caused by smoking or armed violence, war, and terrorism combined. MGI warned that almost half of the global population could be overweight or obese within 1-2 decades. WHO is now confirming this scenario. This problem will drive global health care spending. We will see new initiatives such as education and awareness campaigns, restrictions on sale and marketing of e.g. soft drinks as well as sugar tax. The scale of the problem will also have an impact on the pharmaceutical industry.

– Weight loss products may be part of the solution if the industry is able to provide effective treatments at an affordable price – and this is important as consumers must be able to pay for the treatment themselves. This is because the fundamentals for reimbursement through health care insurance do not exist when such vast numbers of people need treatment. The concept of reimbursement for public insurance is based on the idea that we, as part of society, will pay for the few who need treatment, and this principle is the same for companies offering private insurance coverage. Mexico is already facing these problems at scale and therefore is a cash market. The vision of our partner, Medix, is to be part of the solution and to achieve this, they are offering a broad range of products including weight loss products, nutrition, health facilities, education, lifestyle programs etc. I hope that tesofensine will be a powerful tool in this package for the benefit of patients and Mexican society.

Finally, what are your ambitions for partnerships during this year, and what are you looking for in a potential partner?

– As I mentioned is our Q4 2022 report, we see significant potential for multiple value-creating milestones in 2023. This includes the establishment of partnerships around our programs. We have had both non-confidential and confidential meetings with many biopharmaceutical companies. Of those, many have entered our program data rooms and several of those are interested in the same programs. We can’t go into too much details at this stage, but I can say that we currently have constructive discussions about deal structure and financial terms with several potential partners. Based on these discussions, our objective is to establish at least two new partnerships this year, with at least one being concluded before midyear 2023.

– Our objective with these partnership discussions is to secure the development of our programs in the best possible way and at the same time obtain non-dilutive funding for those programs we will develop internally. For our clinical programs, the ideal partner would have the financial strength and capabilities to progress our program forward to commercialization.

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