Atopic keratoconjunctivitis, or AKC, is a severe allergic conjunctivitis which usually persists all year and for which the allergen(s) are usually unidentified. AKC, which is an orphan disease, mainly affects adults and is triggered by mast cell activation secondary to inflammatory stimuli including eosinophils, neutrophils and Th2-generated cytokines.
Treatment is initially with topical lubricants, antihistamines, immunomodulators (e.g. ciclosporin A) and intermittent steroids but systemic immunotherapy may become necessary in patients unresponsive to topical therapy.
AKC sufferers usually exhibit symptoms such as itching, burning, tearing, erythematosus and swollen eye lids. The disease may lead to corneal scarring and may also lead to vascularization of the cornea. Both eyes are usually affected equally. There is substantial unmet need for topical agents that will prevent the progression of corneal involvement and the requirement for systemic immunomodulators.
During the third quarter of 2018, we commenced a Phase I/II randomized, double blinded, placebo-controlled trial with an initial three patients (Part A) prior to the blinding (Part B) to evaluate the safety and efficacy of nomacopan in patients with the inflammatory mediated eye disorder AKC.
- In October 2019, Akari reported data from AKC patients – biopsy tissue expressed the complement C5a receptor 1 and the leukotriene LTB4 receptor BLT1 on and within the surface of the eye, which suggests that inhibition of both LTB4 and C5 by nomacopan may provide a therapeutic effect by reducing both proinflammatory pathways, and redness, mucous and excess tearing associated with activation of BLT1 and C5a receptors
- Enrolment into Part B of this study was paused due to the COVID-19 crisis, and the study has now been unblinded to help evaluate next steps. The interim data, of 8 AKC patients from part A and Part B (4 active, 4 placebo) appears encouraging and shows nomacopan eyedrops are safe and comfortable and in this small data set may show an efficacy signal, although the patient numbers are too small to show statistical significance on efficacy measures between the two treatment groups. Akari recently received FDA approval for an IND for treatment with topical nomacopan which opens up the potential to broaden our topical ophthalmological program.