The future of obesity treatment: Iconovo develops intranasal semaglutide
Iconovo has initiated the development of an intranasally inhaled and reformulated version of semaglutide to treat obesity. By utilizing its inhalation-driven intranasal device, ICOone Nasal, the company aims to create a more user-friendly treatment than current semaglutide injections. The goal is to achieve preclinical proof-of-concept and enter into a licensing agreement, according to CEO Johan Wäborg in an interview with BioStock.
In recent years, significant advances have been made in the pharmaceutical field for treating obesity, particularly through Novo Nordisk’s development of the GLP-1 receptor agonist semaglutide, which has had a major impact and revolutionized treatment.
Semaglutide is the active substance in Wegovy, used for treating overweight and obesity, and Ozempic, used for type 2 diabetes. The drugs function by mimicking a hormone naturally produced by the body to regulate blood sugar and suppress appetite. In 2023, these products generated sales of USD 18.4 billion, and the total GLP-1 market is projected to grow to USD 120 billion by 2030, according to Global Data.
Iconovo sees a market opportunity
Lund-based Iconovo has identified an opportunity to position itself in the growing market for GLP-1 products by developing an intranasally inhaled semaglutide treatment for obesity and overweight. In May, the company made a key advancement toward this goal by filing a patent application for its inhaled GLP-1 products. Iconovo has since initiated development and selected its intranasal inhaler, ICOone Nasal, as the delivery platform, enabling nasal administration.
Inhaling GLP-1 via the nose instead of injection
Currently, semaglutide treatments are only available as subcutaneous injections or oral tablets (Rybelsus). Administering the substance intranasally is a more user-friendly method than the existing alternatives, creating commercial opportunities for Iconovo.
With an intranasal treatment, patients avoid the discomfort of injection needles, simplifying the learning process and improving treatment adherence and acceptance. This alternative would be more convenient for patients and eliminate the need for refrigeration.
Two examples of products successfully reformulated from injections to intranasal use are adrenaline (Neffy) and glucagon (Baqsimi).
ICOone Nasal enables easy handling
Iconovo’s intranasal semaglutide product will be based on an updated version of the company’s intranasal dry powder inhaler, ICOone Nasal. The new version has improved dosing accuracy and user-friendliness compared to the previous version and it was developed in collaboration with the Bill & Melinda Gates Foundation.
ICOone Nasal is designed 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 the initiation of treatment and improve patient adherence to treatment compared to today’s semaglutide injections.
The inhaler is driven by the user’s own inhalation, providing a natural distribution of the powder on 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 a rapid and high absorption of the drug.
Aiming for licensing agreement
Iconovo plans to develop the product up to the preclinical proof-of-concept stage while initiating discussions with potential licensing partners for clinical development. A commercial launch is possible only after the patent expiration for semaglutide in Canada and China in 2026, and in Europe and the USA in 2031.
Obesity is 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 discusses the project
BioStock contacted Iconovo’s CEO, Johan Wäborg, to learn more about the company’s strategy and development plans for the GLP-1 project.
What activities do you plan to carry out to achieve preclinical proof-of-concept with semaglutide in ICOone Nasal?
– The first step is to develop a stable powder formulation with the correct particle size that will, we believe, provide high bioavailability. Next, we will study pharmacokinetics and bioavailability in suitable in-vivo animal models and perform the necessary toxicological evaluations. Simultaneously with the formulation development, we will assess the performance of ICOone Nasal with this specific formulation.
How extensive will the clinical studies need to be to bring the product to market?
– Our goal is to achieve a pharmacokinetic profile for intranasal semaglutide that is similar to the injected version. Therefore, we expect to achieve the same efficacy and side effects as the injectable treatment. This means the toxicology program can be smaller than usual, but we still need to conduct clinical pharmacokinetic and pharmacodynamic studies in humans. To move forward, we plan to collaborate with a partner who can manage and fund the clinical program. Together, we will need to discuss the clinical program that targets market approval and ensures the product’s competitiveness. Given that semaglutide is already approved, we expect to be able to leverage the simplified 505(b)(2) pathway in the U.S.
Are there any competitors developing a similar product?
– As of today, we are unaware of any other company developing an intranasal semaglutide product. Some companies have explored older and less effective GLP-1 analogues, but these have been focused on lung inhalation. Previous studies with naïve GLP-1 have demonstrated that nasal absorption is possible, providing a strong rationale to expect similar results with semaglutide.
Finally, what will benefit patients most if you succeed in developing an inhaled semaglutide treatment?
– This is the first step toward developing needle-free obesity treatments without compromising bioavailability. An intranasally administered semaglutide will eliminate the aversion to injections among patients, increase patient acceptance, and thus improve treatment adherence. Studies from the U.S. show that over 50 per cent of patients discontinue their GLP-1 medication within a year. Additionally, the product is easier to teach patients to use, making it easier to initiate necessary treatment early.
