WASHINGTON (dpa-AFX) - Apitope, a clinical stage biotech company, has posted positive results in a first human trial of its ATX-GD- 59 anitbody, a treatment for thyroid disorder Graves' disease.
The stage 1 study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves' disease. The majority of the patients were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment.
Graves' disease is one of the most common autoimmune diseases with about 10 million patients across Europe and the US. However, there have been no treatments in more than 60 years. With Graves' disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients.
'It is very exciting to see these promising Phase I results where ATX-GD-59 has shown both an encouraging safety and tolerability profile as well as efficacy. With current first-line treatments having a high failure rate, and the second-line treatments being either invasive surgery or radioiodine, ATX-GD-59 demonstrates the potential to address the high medical need for a new, safe and effective treatment for the neglected field of those suffering from Graves' disease,' Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commenting on the results said.
Copyright RTT News/dpa-AFX