Approaching the Clinical Inflection Point

Akthelia Pharmaceuticals held a presentation this week following its Annual General Meeting at Hilton Reykjavík Nordica, under the title Approaching the Clinical Inflection Point. The meeting covered the company’s current status, its next development steps, and the path toward clinical trials. The briefing brought together shareholders, advisors, and members of Akthelia’s scientific and medical network.  A special guest at the meeting was Prof. Dr. Markus Gerhard, a physician and professor at the Technical University of Munich and a member of Akthelia’s Scientific Advisory Board.

Important Support for Cancer Treatment

Akthelia is currently preparing the first clinical studies of AKT-011, intended to protect the mucous membrane of the gastrointestinal tract from damage that occurs during cancer treatment, a very common complication of such therapies.  Cancer treatments attack rapidly dividing cells. This includes cancer cells, but also healthy cells, including cells in the stomach, gastrointestinal tract, and intestines. As a result, the mucous membrane can become weakened, increasing the risk of inflammation, infections, and other serious complications.

Urgent Need for New Drugs

Research indicates that AKT-011 may significantly reduce this damage and better support the body’s defenses during cancer treatment. Around one-fifth of all patients experience such complications, which means the need for new solutions is considerable. According to information presented at the meeting, AKT-011 could become the first drug specifically aimed at this problem.

Alongside the development of AKT-011, Akthelia is also working on other projects. These include IN-ARMOR, which focuses on developing new treatments that strengthen the body’s natural defenses against infections. The aim is to reinforce the body’s own defense systems rather than relying solely on traditional antibiotics, thereby responding to one of the greatest challenges in medicine today: antimicrobial resistance.

The project has received a grant of  EUR 6 million from the European Union. Akthelia and the University of Iceland are the largest participants in the grant, which involves collaboration between sixteen universities, institutions, and companies.

The Path from Research to Clinical Use

Dr. Markus Gerhard gave a presentation at the meeting on the path from early research to clinical use and the key steps involved in developing new treatments. He reviewed the status of Akthelia’s research and the next steps that will bring AKT-011 closer to clinical use.

“There is a major medical need for new solutions that can reduce serious complications of cancer treatment. What is particularly interesting about AKT-011 is that it is based on a different approach than those pursued so far,” said Dr. Markus Gerhard, adding that AKT-011 is highly promising.

Dr. Gerhard is a physician and professor of medical microbiology and immunology at the Technical University of Munich. For many years, he has studied the relationship between microbes, inflammation, and serious diseases, including cancers of the gastrointestinal tract. He recently joined Akthelia’s Scientific Advisory Board, further strengthening the company’s scientific foundation.

Main projects and milestones

At the meeting, Egill Másson, CEO of Akthelia, also reviewed the company’s current position, main projects, and upcoming milestones. He noted that in recent periods Akthelia has worked systematically to define its clinical path and prepare the next steps toward human studies. Results from preclinical studies and ongoing preparatory research have played an important role in this work.

The first defined patient group consists of patients with multiple myeloma who undergo high-dose drug treatment before stem cell transplantation. This group is considered well suited for the first studies, as gastrointestinal complications are both common and serious among these patients, and the need for new solutions is therefore significant.

Financing and Next Steps

The meeting also covered financing for the next phase of development. Akthelia is currently working to secure funding to support the final preparations for applications and the first human studies. This includes manufacturing, safety studies, and other key elements required to begin clinical trials.

The goal is to create the conditions for the company to enter its first clinical phase in the coming months, provided plans proceed as expected.

“We are approaching an important turning point in Akthelia’s development. In recent periods, we have strengthened operations and built a strong scientific foundation. We are seeing considerable interest from the healthcare and scientific communities, as there is an urgent need to solve the problem that AKT-011 is designed to address.

The project is about improving the wellbeing of the many patients who need to undergo cancer treatment, reducing inflammation and relieving suffering, while also helping prevent disruption to the cancer treatment itself. Today’s meeting was an important opportunity to review where the company stands, what lies ahead, and how we see the next steps toward clinical development,” says Egill Másson, CEO of Akthelia.