In the wake of the groundbreaking GLP-1 receptor agonists, a number of new obesity treatments and weight management approaches are emerging  – and a few of them come from the Nordic region.

Behavior

Lifestyle changes are critical for weight loss, even for patients taking the GLP-1 anti-obesity drugs, and we all know that implementing and maintaining lifestyle changes can be really hard. Finnish digital health company Onnikka Health has developed a solution to support weight management and this critical lifestyle change. The company originated from the University of Oulu and professor Markku Savolainen’s quest to develop an accessible and cost-effective solution for the obesity epidemic.

While GLP-1 receptor agonists are often very effective in helping with reducing food intake, their impact typically disappears with the ending of the medication, unless the treatment is supported by an efficient lifestyle intervention.”

“Achieving sustained weight loss requires a permanent change in one’s lifestyle and eating behavior. While GLP-1 receptor agonists are often very effective in helping with reducing food intake, their impact typically disappears with the ending of the medication, unless the treatment is supported by an efficient lifestyle intervention. For the majority of obese people, weight-loss drugs are not an option due to cost, availability, or some other reason, whereas efficient lifestyle intervention can be a very good choice for most people,” says Teppo Virkkula, CEO of Onnikka Health.

Savolainen and his team joined forces with Harri Oinas-Kukkonen, a professor of information systems science whose team has developed a Persuasive Systems Design method (PSD) that can influence users to change attitudes and behavior for a sustained period. The two teams combined aspects of behavioral change with PSD.

 

Teppo Virkkula, CEO, Onnika Health

 

“Onnikka is all-digital and a cost-effective lifestyle intervention which helps people achieve sustained lifestyle changes and weight loss. It has been systematically developed over more than ten years by using a scientific framework that is proven to impact people’s thinking, attitudes, and behavior,” says Virkkula.

Most users lose 2-5% of their weight with Onnikka and keep it off for many years as proven by clinical studies, according to the company. “Users especially like Onnikka’s gentle and positive approach and non-intrusiveness, as evidenced by very good user feedback and excellent retention rates of over 75% for the one-year program,” says Virkkula.

According to the WHO, one in eight people, or more than one billion people, are now living with obesity, and the problem is forecasted to get even worse, emphasizes Virkkula.

“The economic impact is huge. It is estimated that 10% of all healthcare costs are related to overweight and obesity. The need for efficient, scalable, and cost-efficient solutions to tackle the problem has never been greater,” he concludes.

 

Prevention

Preventive health is on the rise and Swedish healthtech company Sigrid Therapeutics aims to prevent chronic lifestyle diseases, including obesity, with its new materials platform technology, SiPore.

“Obesity is a global burden affecting billions of people. If nothing is done, obesity could cost the world over USD 4 trillion a year by 2035. It will not be sustainable to treat billions of people with drugs. A healthy lifestyle and early intervention is key for preventing obesity,” emphasizes Sana Alajmovic, CEO and co-founder of Sigrid Therapeutics.

Sigrid Therapeutics is grounded in research conducted at Stockholm University and Karolinska Institutet and co-founder professor Tore Bengtsson’s discovery that undesirable changes in metabolism are normalized after the ingestion of modified silica particles. SiPore consists of precisely engineered micron-sized silica particles with tailored porosity. Inside the gut, these particles work as a molecular sieve by mechanically separating digestive enzymes from undigested food, thereby improving metabolic health through a gentle mode of action, according to the company. The particles pass through the body without being absorbed and are safely eliminated in the same manner as food.

It has a superior safety profile as it acts locally in the gut, which makes it a perfect long-term solution for those who cannot tolerate GLP-1 treatments or would like to sustain their weight loss post GLP-1 treatments.”

“Our SiPore technology is uniquely positioned to help manage weight sustainably. It has a superior safety profile as it acts locally in the gut, which makes it a perfect long-term solution for those who cannot tolerate GLP-1 treatments or would like to sustain their weight loss post GLP-1 treatments,” explains Alajmovic.

 

Sana Alajmovic, CEO and Co-Founder, Sigrid Therapeutics

 

The company’s lead product candidate, SiPore21 is an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetes, and newly diagnosed type 2 diabetes, but the pipeline of potential products based on the platform also includes obesity and treatment of excessive bile acid levels post bariatric surgery, and weight loss.

“Numerous animal and clinical trials conducted on our breakthrough medical device gel have demonstrated its ability to effectively and safely reduce caloric absorption from meals, as well as to decrease both post-meal and long-term blood sugar levels, all while preserving vital muscle mass,” states Alajmovic.

The company has also recently launched an over-the-counter dietary food supplement, Glucose Stabiliser, designed to control blood sugar and body weight. It is supposed to reduce calorie intake from fat and carbohydrates, and it is taken before the two biggest meals of the day.

“Consumer studies show that 81% of consumers use the product for weight loss. Furthermore, 78% report successful regulation of blood sugar levels, and 77% experience reduced bloating,” says Alajmovic.

 

Delaying

Beyond the GLP-1 receptor agonists, companies are also looking at other mechanisms of action on weight loss. For example, Swedish Empros Pharma aims to launch its drug candidate EMP16 in 2027.

“EMP16 is an oral drug that is safe and well tolerated. It will also be cost effective,” states Arvid Söderhäll, CEO of Empros Pharma. “It has proven to have a good effect on weight loss, even though it does not entail the very fast weigh loss gained from the GLP-1 drugs. Weigh loss with EMP16 is about 70% fat and 30% muscle mass, which is a very good result. Additionally it has shown to have a good effect on many medical complications that accompany obesity, such as type 2 diabetes, cardiovascular diseases, liver health, and so on.”

EMP16’s main mechanism of action is to delay normal food digestion and absorption processes until the end of the small intestine. It is a fixed-dose combination of two locally active, safe, and established active drugs (orlistat and acarbose). The multiple-unit, modified-release formulation has been designed to maximize the effect of the drugs as well as improve tolerability.

“We have just finished a Phase 2b study and we will have an end-of-Phase-2 meeting with the FDA later in May this year. In total, we have concluded four clinical studies with EMP16 and we plan to initiate Phase 3 studies later this year,” says Söderhäll.

 

Team Empros Pharma: Mark Quick, Stefan Grudén, Arvid Söderhäll, Halide Shala and Ulf Holmbäck.

 

Empros Pharma was founded in 2013 by researchers and entrepreneurs at Uppsala University together with the investor Flerie Invest, and Arvid Söderhäll has identified several market opportunities for EMP16.

It is widely known that in practice GLP-1 drugs are not used chronically. About 70% of the patients quit within a year and the patients regain weight as soon as their treatment has finished. EMP16 has a better possibility to function as a chronic treatment.”

“Firstly, as a chronic obesity treatment, perhaps following a treatment with a GLP-1 drug. It is widely known that in practice GLP-1 drugs are not used chronically. About 70% of the patients quit within a year and the patients regain weight as soon as their treatment has finished. EMP16 has a better possibility to function as a chronic treatment,” he states.

“Secondly, EMP16 is very effective for about one third of patients (the responders), in fact, they respond so well that the weight-loss results are comparable with the market leaders. The patient group typically consists of those who have relatively moderate obesity and not too many comorbidities.”

A third market segment for EMP16 is as a combination drug, concludes Söderhäll.

“The mechanism of action is not systemic and can therefore be combined with other obesity drugs. For example, a low dose of EMP16 in combination with a low dose of a GLP-1 drug can achieve a good effect, perhaps completely without side effects.”

 

Modulating

Danish biopharma company Saniona’s expertise in ion channel drug discovery has also led to the development of a potential new obesity treatment. Tesofensine is a triple-monoamine reuptake inhibitor that modulates brain activity by increasing the levels of three neurotransmitters, dopamine, serotonin, and noradrenaline, which are all intimately involved in regulating appetite, food-seeking behavior, and metabolism. Tesofensine is provided in tablets and will not require titration.

Its weight-reducing effect has been confirmed in a six-month Phase 2 clinical trial in patients with obesity, indicating that tesofensine at the expected recommended dose of 0.50 mg per day provides a weight loss of 10% or more in 24 weeks.

Compared to the subcutaneous GLP-1 analogs, tesofensine is more convenient to use as it is provided in tablets. Furthermore, there is no need for titration.”

“The substantial weight loss and benign safety profile of tesofensine suggest that tesofensine would have a positive impact on cardiovascular outcome like some of the GLP-1 drugs, but unlike several non-GLP-1 medications for treatment of obesity,” says Thomas Feldthus, co-founder and CEO of Saniona. “Compared to the subcutaneous GLP-1 analogs, tesofensine is more convenient to use as it is provided in tablets. Furthermore, there is no need for titration.”

 

Thomas Feldthus, CEO and Co-Founder, Saniona. Photo: Christoffer Askman

 

The company’s partner Medix has completed a Phase 3 program with tesofensine in people with obesity, confirming the efficacy and a favorable safety profile. Based on these studies Medix submitted a new drug application to the Mexican food and drug administration, COFEPRIS, in 2019 for approval of tesofensine for the treatment of patients with obesity. The regulatory path was complicated by COVID-19 but in February 2023 the technical committee on new molecules (an advisor to the regulatory agency in Mexico) provided a favorable opinion on tesofensine for the treatment of obesity. Medix subsequently filed a formal application and is currently in close dialog with the regulatory agency in Mexico anticipating a favorable outcome. According to Medix, the current market for prescription medicine for obesity in Mexico is approximately USD 200 million.

“Medix has an inventory of drug substance and a large facility for producing the tablets. Therefore, they should be able to launch the product relative fast following approval, probably within six months,” says Feldthus. “Mexico would be the first country in the world to register tesofensine for obesity. If approved, we may start to introduce it in other territories starting with South America.”