Pipeline

Therapeutic product candidates

Graves’ disease

Graves’ disease is an autoimmune disease in which the immune system mistakenly attacks the thyroid gland and causes it to become overactive. It causes overproduction of thyroid hormone leading to various symptoms including muscle weakness and eye bulging - the latter with the potential risk of blindness. Graves' disease is one of the most common autoimmune diseases, with approximately 10 million patients across Europe and the US.15,16

First line therapies for Graves’ disease consist of anti-thyroid drugs to reduce the production of thyroid hormones and/or radioactive iodine therapy. Many patients often fail current first line therapy and the last remaining option is surgical removal of the thyroid, leading to lifelong thyroid replacement therapy and potential complications such as scarring and vocal cord damage.

ATX-GD-59 – potential first in class disease-modifying treatment for Graves’ disease

Apitope’s ATX-GD-59 is the first potential treatment to target the immunological basis of Graves' disease and demonstrates potential to be the first innovative treatment in more than 60 years.

ATX-GD-59 is a peptide mixture of two different, highly soluble apitopes derived from TSH-receptor. Preclinical studies have demonstrated that ATX-GD-59 has a significant impact on the anti-TSHR T-cell and B cell response17.

A recently completed proof of principle study has demonstrated evidence of efficacy in the majority of patients by the reduction of the antibodies and hormones associated with Graves’ disease. In addition, the treatment has also demonstrated a very favourable safety profile18. Apitope’s planning for the phase 2 study is underway.

The following video features Prof David Wraith, Apitope’s Chief Scientific Officer, who discusses the development of the disease modifying therapy that could lead to the first new line of treatment for Graves’ disease in a generation; and Janis Hickey, Founder of the British Thyroid Foundation, who describes the effects of living with Graves’ disease from a patient perspective

15 Burch, H. B., & Cooper, D. S. (2015). Management of Graves' disease: a review. Jama, 314(23) 2544-2554
16 4Th edition of Physician Assistant Review edited by Patrick C. Auth, Morris D. Kerstein (2013) p218
17 Jansson L, Vrolix K, Jarhaus, A. et.al. (2018) Immunotherapy with apitopes blocks the immune response to thyroid stimulating hormone receptor in HLA-DR transgenic mice. Endocrinology 159(9); 3446-3457
18 Pearce SHS., Dayan C., Wraith DC, et al (2019) Antigen-specific immunotherapy with thyrotropin receptor peptides in Graves’ hyperthyroidism: a phase 1 study. Thyroid, vol 29 (7); 1003-1011.