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(14.01.2025) Acromegaly is a rare disease in which the body does not stop growing due to an overproduction of growth hormone. Novel drugs are being tested in studies in Freiburg.

He was 2.18 meters tall and appeared in two James Bond films. The actor Richard Kiel became known as "the Biter" with his fearsome teeth, with which he could even crack steel. In his private life, the giant suffered from the hormone disorder acromegaly. A rare disease in which body tissue grows uncontrollably due to an overproduction of growth hormone.

What is acromegaly?

"Acromegaly is a rare and serious disease in which the pituitary gland, the so-called hypophysis, produces too much growth hormone," explains Prof. Dr. Jochen Seufert, Head of the Department of Endocrinology and Diabetology at the Department of Internal Medicine II at the Freiburg University Medical Center. "This leads to abnormal growth of bones and tissue, particularly in the hands, feet and face." Those affected often suffer from joint pain, headaches, visual disturbances and other complaints. The disease progresses gradually, which makes diagnosis difficult. If left untreated, acromegaly can have serious health consequences such as cardiovascular disease or diabetes. In more than 95 percent of cases, acromegaly is caused by a benign tumor of the pituitary gland.

The injections are stressful for those affected

"In the treatment of acromegaly, somatostatin receptor agonists have been used for years in drug therapy to suppress the production of growth hormone," says Seufert. These drugs have to be administered regularly, often in the form of injections, which is a burden for patients.

New treatment options in the clinical trial

A new formulation of a somatostatin receptor agonist has now been investigated as part of an international study at the University Medical Center Freiburg. This means that the active ingredient has been converted into a new, easy-to-use drug form. What is special about this is that this new formulation no longer has to be administered by a doctor, but can be injected by the patients themselves. This could make the treatment process much easier in the future. "The aim of this study was to test the efficacy and safety of this new form of self-administration and thus significantly improve the daily lives of those affected," says Seufert.

Successful certification by the FDA

As acromegaly is a rare disease, the study at the Freiburg University Medical Center is a multicenter project that is being conducted internationally. "These studies are of great importance in order to test and further develop new treatment options," emphasizes Seufert. As part of this study, an inspection was carried out in June 2024 by the US Food and Drug Administration (FDA), which inspects centers worldwide to verify compliance with good clinical practice. The result of the inspection: "No action indicated" - the best possible result awarded by the FDA. This confirms that the study at the University Medical Center Freiburg was conducted according to the highest standards.

Therapy for patients could be significantly improved

"The successful certification is an important step towards the approval of the new treatment method in the USA and could also significantly improve treatment for acromegaly patients in Germany," says Seufert - and emphasizes the importance of such studies: "These projects not only contribute to the further development of treatment options, but also strengthen confidence in the safety and care with which new drugs are developed and approved."

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