Therapeutic product candidates
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.11 12
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 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 currently being evaluated in a Phase I study in patients and preliminary analysis is showing promising signs of early efficacy in the majority of patients and a very favourable safety profile. Final results are expected in the first half of 2018.
Following positive Phase I results, Apitope plans to initiate a Phase II study in the first quarter of 2019.
In addition, Graves' disease provides fast market entry opportunities through rare and serious orphan indications with high unmet medical need including sight-threatening Graves' ophthalmopathy and paediatric Graves' disease.
Apitope has just completed and reported positive data for it’s first in man phase I study of its potential first in class therapeutic (ATX-GD-59) for the treatment of Graves Disease. Apitope’s planning for the phase 2 study is underway.
The 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.
11 Burch, H. B., & Cooper, D. S. (2015). Management of Graves' disease:areview. Jama, 314(23)
12 Physician Assistant Review p218