Saniona aiming for new clinical data and first market approval
In its recently published interim report, Saniona’s CEO Thomas Feldthus highlights the external interest in one of the clinical candidates and two of the preclinical candidates, while reiterating the target of delivering clinical updates for SAN711 and SAN2355 before year-end. The company is also eyeing a possible first market approval of tesofensine, targeting the obesity market.
– We are awaiting the final decision for approval of tesofensine for obesity in Mexico. If successful, Saniona will be entitled to an upfront payment and double-digit royalties on product sales.
Saniona laid the foundations for its epilepsy pipeline last year. The portfolio features SAN711, a phase II-ready candidate drug targeting absence seizures, SAN2219 for the treatment of acute repetitive seizures, and SAN2355 addressing refractory focal onset seizures.
The Danish biotech also has four programs beyond epilepsy with tesofensine leading the way, progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Tesomet is ready for phase IIb, for the treatment of rare eating disorders. Furthermore, SAN903 is ready for phase I in inflammatory bowel disease, while SAN2465 is set for preclinical development and aimed at treating major depressive disorder.
Progress during the first half of 2024
In the interim report published August 29, Saniona’s CEO Thomas Feldthus highlights the progress made during the first half of 2024. The overarching focus is to progress its pipeline of drug candidates targeting neurological and psychiatric disorders.
In June, Saniona filed a Clinical Trial Application (CTA) for a phase I multiple ascending dose (MAD)/biomarker study in adults for SAN711. If approved, patient recruitment could begin in September, with subsequent top-line results by year-end.
The study will lay the foundation for a clinical proof-of-concept study in children with absence seizures, which could start next spring. Progress is also being made with SAN2355. Recently, Saniona finalized the process optimization for this best-in-class candidate, a new generation of Kv7.2/Kv7.3 activators for the treatment of focal onset seizures. The company expects to communicate more in Q3 and, if funded, to apply for the start of phase I clinical studies over the summer 2025.
The approval of tesofensine
Saniona’s partner Medix filed for regulatory approval for tesofensine in Mexico in May 2023. One year later, Medix submitted an updated application with additional information and documentation. The regulatory agency has had no further comments or questions, and Saniona is now awaiting the final decision for the approval of tesofensine as a new obesity treatment in Mexico.
In the interim report, Thomas Feldthus commented on the possible implications of a positive outcome:
If successful, Saniona will be entitled to an upfront payment and double-digit royalties on product sales. Tesofensine may be an important product for treatment of obesity in Mexico and a regulatory approval may also open new opportunities in other territories. Therefore, it could be a major source of income and news flow going forward.
Tesofensine’s weight loss potential
In June, Saniona commented on the potential mechanism of action behind tesofensine’s weight loss effect, based on an article published in PLOS One by an obesity research group led by Ranier Gutierrez at the National Polytechnic Institute in Mexico.
The authors found that tesofensine strongly modulated lateral hypothalamus activity in obese rats and inhibited a subset of GABAergic neurons attenuating their ability to promote feeding behavior. They also concluded that tesofensine induced more weight loss through the appetite suppressant effects in obese rats than in lean rats. The research group also showed that tesofensine blocked weight loss tolerance (weight rebound) and prolonged the weight loss induced by the weight loss principle 5-HTP. Tesofensine was evaluated to have a benign adverse effect profile and differentiation to certain other obesity treatments principles tested.
Commenting on these findings, Karin Sandager Nielsen, CSO of Saniona, said:
– These data strongly support the promotion of tesofensine as a novel effective treatment for weight loss in obese people. The experiments demonstrate strong experimental skills and scientific experience of the responsible scientists and their excellence in the field. The techniques used are highly sophisticated and well suited for demonstrating tesofensine’s effects at specific neuronal pathway levels and brings us closer to understanding the cellular and network mechanism of action of tesofensine’s unique efficacy.
Aiming at least one new partnership in 2024
As the company anticipates the potential approval of tesofensine and while advancing its pipeline, Saniona is also actively pursuing at least one new commercial partnership in 2024. Ongoing discussions are focused on one of Saniona’s clinical programs and additional interest is being explored for two preclinical candidates and a research initiative.
The objective is to secure a deal that will provide the necessary funding for the continued development of its broader asset portfolio. Financially, the company maintains a stable position with SEK 54.4 million in cash and cash equivalents.
In a recently published BioStock interview, Thomas Feldthus commented on the external interest in Saniona’s pipeline:
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.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.
