Apitope, a drug discovery and development company focused on disease-modifying peptide treatments for the underlying cause of autoimmune and allergic diseases, announced that its peptide therapy for the treatment of Factor VIII intolerance, ATX-F8-117, has formally entered preclinical development.

Apitope has, through its patented discovery platform, completed the research work to confirm that the two peptides in ATX-F8-117, derived from Factor VIII, have the potential to treat and prevent inactivating alloantibody development in haemophilia A patients treated with Factor VIII.

Haemophilia A patients are normally treated with Factor VIII to help with the clotting of their blood. However, since these patients’ immune systems have had no or low exposure to normal FVIII, they are often not fully tolerant to the Factor VIII used to treat their condition. As a consequence, up to 30 per cent of these patients develop Factor VIII inhibitor antibodies. The development of these antibodies is the most serious complication that can develop and significantly limits the treatment of this disorder as well as increasing the cost burden. Currently, there are few therapies available to help inhibitor patients making the Apitope approach potentially life changing for patients and their carers.

Dr. Keith Martin, chief executive officer, said “The potential therapeutic impact of this product could be an important step in the fight to help haemophilia A patients who cannot benefit fully from Factor VIII replacement therapy. We are pleased that this is the product to make the next step into development.”

Apitope’s mission is to develop products based on therapeutic peptides to treat a range of life-threatening autoimmune and allergic diseases, including rare conditions. The R&D portfolio currently comprises seven programmes in clinical and preclinical phases, targeting multiple sclerosis, Factor VIII intolerance, uveitis, and the thyroid-related autoimmune condition, Graves’ disease.

Prof David Wraith, CSO and founder of Apitope, added, “Bringing the next product through into preclinical development is a milestone event for Apitope. This further demonstrates that Apitope’s discovery platform can generate new potentially life changing therapies for development and validates the scientific basis of our approach.”

Dr. Keith Martin added, “At Apitope, our focus is on the discovery and development of life changing peptide therapies for autoimmune and allergic conditions that treat the underlying cause of disease by restoring the immunological balance. We are building a strong portfolio of development candidates as well as expanding our discovery capabilities to fully exploit the scientific expertise now established at Apitope. We expect 2014 to be an important year for us with respect to our lead programmes moving through development.”