In recent years, great progress has been made in the pharmaceutical field for the treatment of obesity, not least through Novo Nordisk development of the GLP-1 receptor agonist semaglutide which has had a major impact and revolutionized treatment.
Semaglutide is the active substance in the products wegovy, which is used for the treatment of overweight and obesity, and Ozempic, which are used to treat type 2 diabetes. They work by mimicking a hormone that the body naturally produces to regulate blood sugar and reduce appetite. The products were sold for $18,4 billion in 2023, and the total GLP-1 market is expected to grow to $120 billion by 2030, according to Global Data.
Iconovo sees a market opportunity
Lunda Company Iconovo sees an opportunity to position itself in the large market for GLP-1 products by developing an intranasally inhaled semaglutide treatment for obesity and overweight. In May, Iconovo took an important step towards this goal by filing a patent application for inhaled GLP-1 products. Now, Iconovo has begun development and selected the company's intranasal inhaler ICOone Nasal to the project, which enables administration via the nose.
Inhale GLP-1 through the nose instead of injection
Currently, semaglutide treatments are only available as subcutaneous injections or oral tablet (RybelsusAdministering the substance via the nose offers a more user-friendly method than current alternatives, opening up commercial opportunities for Iconovo.
Intranasal treatment eliminates the need for uncomfortable injection needles, simplifying the learning process and improving patient compliance and acceptance. Such an alternative would not only be more convenient for patients, but would also eliminate the need for refrigerated storage.
Two examples of products that have been successfully reformulated from injections to intranasal use are adrenaline (neffy) and glucagon (Baqsimi).
ICOone Nasal allows for easy handling
Iconovo's intranasal semaglutide product will be based on an updated version of the company's dry powder inhaler ICOone Nasal, with improved dosing accuracy and user-friendliness compared to before. The new version has been developed in collaboration with Bill & Melinda Gates Foundation.
ICOone Nasal is intended for single use, with a simple design and low manufacturing cost. According to Iconovo, the inhaler is easy to learn to use, which could simplify treatment initiation and improve patient compliance compared to current semaglutide injections.
The inhaler is powered by the user's own inhalation, which provides a natural distribution of the powder across the nasal mucosa. According to the company, the substance easily reaches the nasal mucosa, which has a large surface area and many blood vessels, leading to rapid and high absorption of the drug.
Aiming for a license agreement
Iconovo plans to develop the product to preclinical proof-of-concept while initiating discussions with potential licensing partners for clinical development. A commercial launch is only possible after the patent expiration of semaglutide in Canada and China in 2026, and in Europe and the US in 2031.
Overweight and obesity are the first indication for Iconovo's GLP-1 project, but there are also opportunities to include other metabolic diseases such as type 2 diabetes, fatty liver, cardiovascular disease and sleep apnea.
CEO tells more about the project
BioStock contacted Iconovo's CEO Johan Waborg to learn more about the company's strategy and development plans for the GLP-1 project.
What activities do you plan to implement to achieve preclinical proof-of-concept with semaglutide in ICOone Nasal?
– The first step is to develop a powder formulation with the right particle size and that is stable, and which we also believe will provide high bioavailability. In the next step, we will study pharmacokinetics and bioavailability in appropriate in-vivo animal models, as well as perform the necessary toxicological studies. Simultaneously with the formulation development, we will assess the performance of ICOone Nasal with this particular formulation.
How extensive clinical studies are then required to bring the product to market?
– Our goal is to achieve a similar pharmacokinetic profile with intranasal semaglutide as for injected. We therefore expect to also achieve the same effect and side effects as for injected treatment. This means that the toxicology program can be made smaller than normal. We will need to conduct both clinical pharmacokinetic and pharmacodynamic studies in humans. We will seek a partner to run and finance the clinical program and we will need to discuss the clinical program with this partner as we are not only striving for market approval but also a competitive product. However, since semaglutide is approved today, we expect to be able to use the simplified regulatory 505(b)(2) process in the USA.
Are there any competitors developing a similar product?
– We are not currently aware of any other company developing an intranasal product for semaglutide. There are a few companies that have worked with other older and less effective GLP-1 analogues, but usually for inhalation via the lung. It has previously been shown with naive GLP-1 that uptake via the nose is possible and thus there is good rationale for similar results for semaglutide.
Finally, what will be the biggest benefits for patients if you succeed in developing an inhaled semaglutide treatment?
– This is the first step in an effort to develop needle-free treatments for obesity without compromising bioavailability. An intranasally applied semaglutide will eliminate the aversion to injections in patients and increase patient acceptance and thus compliance with the treatment. We know from studies in the US that over 50% of patients stop taking their GLP-1 medication within one year. In addition, it will be easier to initiate necessary treatment early as product use is easier to teach.