– This is the first step in Iconovo's new initiative to develop more convenient, reliable and cost-effective treatments for obesity, the company writes.
Iconovos core competence lies in the inhalation area, where the company possesses extensive experience in the development of both inhalers and dry powder formulations.
The company focuses on the development of new inhalation drugs and reformulation of existing substances into inhalation drugs. In recent months, the company has worked to identify promising substances suitable for reformulation, with the goal of building a portfolio of candidates that are ready for partnership.
GLP-1 treatments
Weight loss drugs are a rapidly growing area with significant progress in recent years. Iconovo is now choosing to capitalize on the opportunities in this area by developing inhaled GLP-1 products.
GLP-1 receptor agonists, also called GLP-1 analogues, are drugs that mimic the effects of the hormone GLP-1 (Glucagon-like peptide-1) by binding to its receptor. GLP-1 lowers blood sugar levels by producing insulin and stimulating satiety after eating.
– As a leading inhalation company, with a range of fully developed inhaler platforms and expertise in formulating drug substances into powders, we are in a perfect position to take a step towards reformulating selected products with high market value in areas where inhalation can offer significant patient benefit, writes Iconovo's CEO Johan Waborg i a press release.
Featured area
The most talked about GLP-1 treatment is probably Ozempic (semaglutide), produced by Novo Nordisk for the treatment of type 2 diabetes, but which has also been widely prescribed for obesity. Novo also has a corresponding treatment, wegovy, which contains the same active substance but is intended for weight loss. In Q1 2024, sales of Ozempic amounted to DKK 27,8 billion, while Wegovy was sold for DKK 9,3 billion.
Eli Lilly's challenger, Zepbound, was approved by the FDA in late 2023 and had sales of $517,4 million in Q1.
Although GLP-1 treatments have proven effective for many patients, some challenges remain. According to many patients, the injection treatments are perceived as both expensive and difficult to administer.
– Most of today's GLP-1 treatments, such as Zepbound (Eli Lilly) and Wegovy (Novo Nordisk), are given via subcutaneous injection, which is considered both stressful and painful by many patients, Iconovo writes in its press release.
Competitive advantages of inhaled treatment
Iconovo's inhaled GLP-1 treatment would provide patients with an option that is painless and more convenient. Unlike injection, no refrigeration is required to ensure shelf life, making inhaled treatment more reliable and cost-effective.
Currently, there is an oral GLP-1 treatment, rybelsus (semaglutide in tablet form), on the market and more are in development. However, the oral alternatives have been plagued by low bioavailability.
– So far, bioavailability has been a major challenge and only about 1 percent of the active drug has reached its target, writes Iconovo.
The company estimates that inhaled GLP-1 could reach efficacy levels comparable to injected treatments.
Possibility to include more diseases
Iconovo's project focuses primarily on the treatment of obesity, but there is also the possibility of including other metabolic diseases such as type 2 diabetes, fatty liver, cardiovascular disease and sleep apnea. The company's proprietary inhalers will be used for the project. The initial development phase requires only limited resources, according to Iconovo.
The goal is to license out selected products after achieving preclinical proof-of-concept.
High market value
Iconovo's patent application for inhaled GLP-1 receptor agonists addresses a very large and rapidly growing market valued at USD 35 billion and expected to grow by 17 percent annually to USD 90 billion by 2029, according to GlobalData.
– We are very pleased to be able to take this important step towards the development of next-generation patient-friendly GLP-1 treatments with maintained efficacy, says Iconovo's CEO Johan Waborg.
BioStock contacted Johan Wäborg to learn more about the company's new focus on inhaled GLP-1 products.
First of all, how do you see the significance of Iconovo's new investment in the obesity field for the company's future development?
– We will continue to focus on bringing our generic inhalation treatments to market, most recently with a generic product for Symbicort based on our ICOres platform, followed by generic products for Ellipta from GSK with a focus on Breo /Relvar and Trelegy. However, the next significant wave of growth will come from reformulations of existing substances and here we see a huge market opportunity in the GLP-1 market by replacing injections with inhalation. The clinical results from existing GLP-1 analogues are fantastic and we can offer an alternative that is patient-friendly and does not require an invasive treatment.
Beyond increased patient-friendliness and sustainability, what other potential advantages do inhaled GLP-1 products have compared to injected ones?
– We aim to be able to offer a more patient-friendly product with maintained effect – by replacing injection with inhalation. Existing products are long-acting so we do not expect any additional clinical benefits with inhalation. However, the benefit of avoiding worrying and sometimes painful injections should not be underestimated. In the treatment of many diseases, injection treatments are held back as a last-line treatment – precisely because of patients’ instinctive resistance to penetrating the skin with a needle. If you look at the current US market for glucagon, you will see that a nasal version of glucagon has taken significant market share from injections.
You describe your patent application as broad – could you elaborate?
– We cannot of course go into any technical details, but the patent protects a technology for administering, for example, GLP-1, in the form of an inhaled dry powder. A dry powder offers many advantages because it is stable at room temperature and does not need to be refrigerated. This reduces the cost of the product and makes handling much easier for the user.
– What makes the patent broad is that the technology can be used on a large number of different peptides, of which GLP-1 is only one. Another feature that makes the patent so broad is that the technology can be used to deliver the drug to the nose and to the lung. There is even the possibility of simultaneously delivering the drug to both the nose and the lung in the same breath. This very versatile technology gives the drug developer great opportunities to choose the route that gives the best clinical effect. Together with our inhalers, we now have a complete, versatile and cost-effective platform for the future.
You are entering an area that is highly sought after but also competitive. What opportunities and challenges do you see in the area?
– We know that there are many companies that want a piece of the big pie. Many oral products are being developed that will be patient-friendly in terms of administration, but they often struggle with bioavailability if it is a peptide, and the companies that try to influence the GLP-1 receptor in other ways must both achieve the impressive levels of effect we have seen with Wegovy and Zepbound and at the same time avoid other side effects. We believe that this is a challenge and therefore aim instead to be able to offer a patient-friendly product with the impressive effects that today's products deliver.
What steps do you need to take to reach preclinical proof-of-concept and license the products?
– We need to take a number of steps before we reach preclinical proof-of-concept. We will start by finding good suppliers of the substances we plan to formulate and then develop a formulation that both reaches the respiratory tract, is absorbed into the phloem with sufficient bioavailability with maintained effect and is stable over time. We will also show in selected animal models that the product really reaches the bloodstream as intended. In addition, we will continuously strengthen the patent portfolio for this development.
