Today the Icelandic business newspaper, Viðskiptablaðið published an interview with Egill Másson, CEO of Akthelia. The company is developing AKT-011, a drug designed to protect the lining of the gastrointestinal tract and reduce serious complications associated with cancer treatment. Akthelia joined the portfolio of what is now Kría Venture Fund in 2008, having been founded in 2002.
In the interview, Egill explains that the company is approaching a significant milestone in the drug's development. If clinical trials begin as planned in 2027, this will mark a major transformation for the company, creating new opportunities for financing and collaboration with international pharmaceutical companies.
"This is perhaps the biggest step in the development of a pharmaceutical company. Once a company enters clinical trials, its nature changes significantly. The interest it attracts also changes, as do the requirements imposed by regulatory authorities," says Egill.
Egill explains that damage to the lining of the gastrointestinal tract can lead to life-threatening infections.
"When patients undergo treatment with cytotoxic chemotherapy drugs, these drugs target rapidly dividing cells. These include cancer cells, of course, but also other cells in the body, including the epithelial cells lining the gastrointestinal tract. When these cells are damaged, ulcers can develop, creating a risk that bacteria may pass from the gastrointestinal tract into the bloodstream and cause sepsis."
Gastrointestinal mucositis is a well-known complication of cancer treatment. In severe cases, it can lead to life-threatening infections, prolonged hospital stays, and the need to delay treatment or reduce drug doses.
According to Egill, the frequency and severity of these side effects vary considerably depending on the type of cancer treatment patients receive. In some cases, complications may persist for years after treatment has ended.
AKT-011 originates from research conducted by Guðmundur Hrafn Guðmundsson, Professor at the University of Iceland, and his colleagues, including researchers at Karolinska Institutet in Sweden. Their research has focused on the body's natural immune defences and their interaction with the gut microbiota.
AKT-011 is a novel, patent-protected molecule developed to mimic the protective effects of substances produced by microorganisms in the gastrointestinal tract. Its purpose is to reduce inflammatory responses and accelerate the regeneration of damaged mucosal tissue.
Egill says Akthelia estimates that approximately USD 22 million, equivalent to nearly ISK 2.7 billion, will be required to finance the first two phases of clinical trials. Of this amount, the first phase is expected to cost around USD 7 million and the second approximately USD 15 million. The company has already secured ISK 180 million in funding to prepare for its first clinical trials and is now working to finance the next stages of development.
According to Egill, Akthelia has been in discussions with specialised investment funds over the past two to three years regarding financing for the clinical trials. The response has been positive, and one fund has expressed interest in leading the financing round, although no final agreements have yet been reached.
Akthelia's long-term objective is to generate sufficient clinical data to enter into an agreement with a major international pharmaceutical company. Such a partner could then take over the later stages of development and commercialisation.
"The market opportunity is of such a scale that it requires a pharmaceutical company with extensive market reach and a strong distribution network. We therefore aim to enter into a licensing agreement once the results from Phase II clinical trials are available."
Under the current development plan, this milestone could be reached in 2029–2030.
Read the full interview in Viðskiptablaðið (in Icelandic)
