Nanexa says its long-acting subcutaneous technology could reduce the dosing frequency of popular drugs such as liraglutide, while eliminating the need for aseptic processing and cold chain logistics.

Uppsala has long been a hotbed of biotech innovation in Sweden, but last the city merged with capital Stockholm to form the country’s largest life science cluster, home to just over half of the country’s life science employees and a number of international biopharma firms.

Within this region sits Nanexa, a technology firm that is looking to shake up the delivery of drugs through its atomic layer deposition (ALD) subcutaneous injectable technology, PharmaShell.

ALD, a vapor phase system capable of producing ultra-thin films, is used in both the semiconductor and solar energy space, but Nanexa has developed a patented technique to coat active pharmaceutical ingredients (APIs) to enable the long-acting administration of a range of modalities, including small molecules, peptides, oligonucleotides, and monoclonal antibodies.

PharmaShell works by encapsulating the API particle with a coating of inorganic oxides of between 10 and 30 nanometers, depending on the desired release profile. It is then administered as a suspension under the skin, where it dissolves over days and/or weeks, exposing the API to the systemic circulation. The coating, meanwhile, dissolves into ions which are eliminated by the body through urine, feces, and sweat.

Nanexa is applying its PharmaShell technology to glucagon-like peptide-1s (GLP-1s), targeting the diabetes and obesity markets. Some financial forecasts believe this GLP-1 market will exceed $100 billion by 2030, with Novo Nordisk’s Wegovy and Ozempic (both semaglutide) and Eli Lilly’s Mounjaro and Zepbound (both tirzepatide) leading the drive.

Both semaglutide and tirzepatide are currently available in weekly subcutaneous injections, while other GLP-1s such as Novo Nordisk’s Victoza (liraglutide) are injected daily. Nanexa believes it offers an advantage over current market GLP-1s through the less frequent dosing.

This is “really disruptive technology,” Nanexa CEO David Westberg told a press pack during a facility visit in September. “It’s patient friendly. We can do monthly, quarterly, or even less frequent dosing, working with very high concentrated suspensions and still getting it through an extremely thin needle.” The 30-gauge needle is the same thickness found in insulin pens, which combined with an injection volume of less than 1 ml ensures painless self-administration, enhancing patient comfort.

Furthermore, the technology offers numerous benefits from a production perspective. “The process is extremely scalable. The manufacturing process also involves terminal sterilization, avoiding “extremely costly” aseptic processing. Furthermore, the avoidance of cold chain logistics brings a further significant cost benefit, Westberg said, claiming that for some peptides and proteins cold chain logistics can account for up to 30% of the total cost of goods.

Nanexa’s leading program NEX-22 is assessing the once-monthly administration of liraglutide with the PharmaShell system in collaboration with major shareholder Novo Nordisk. The firm reported positive results from a Phase I diabetes study late last year and presented the findings at the American Diabetes Association in June.

Nanexa is not alone in developing longer-acting and easier to administer anti-obesity and diabetes GLP-1s. Metsara, set to be acquired by Pfizer for $4.9 billion, boasts a pipeline of its own long-acting GLP-1 candidates for obesity and related diseases based on its Halo peptide lipidation technology. The firm is also developing orally administered GLP-1s, a delivery route also being investigated by others including Eli Lilly and Novo Nordisk. The latter has already achieved approval for its tablet Rybelsus (semaglutide) for type 2 diabetes in 2019.

“The tablets will probably have their place in the market,” said Westberg. “There are people that don’t want to use syringes, but there are problems with oral GLP-1s. The GI side effects are quite severe, actually, but they will their part in the market. The market is huge.”

While Novo Nordisk is Nanexa’s largest shareholder with a holding of 17%, Westberg said the company is not restricted on who it can work with, nor on the type of molecule it can work with. Other public programs include testing the PharmaShell system with new formulations of off-patent APIs for multiple myeloma drug (lenalidomide) and Myelodysplastic Syndrome (azacitidine).