About the project

About the disease

Epidemic keratoconjunctivitis (EKC) is a serious and contagious eye infection caused by mainly adenovirus type 8, 19 and 37. Symptoms include inflammation in the conjunctiva (conjunctivitis) and the cornea (keratitis), severe pain, edema and diminished eyesight, tearing, sensitivity to light. Due to the symptoms, the patients are unable to attend work or school, why many working hours are lost every year as a consequence of the disease. The costs to society in terms of both healthcare and loss of production are thus substantial. Also, EKC may have long term implications for the patient’s eye sight.

On a global basis millions of patients are suffering of EKC every year. External ocular infections caused by adenoviruses are among the most common eye infections worldwide. Studies have shown that up to 65% of all conjunctivitis cases are viral and as many as 90% may be adenovirus and can cause considerable morbidity if not treated accordingly. Ocular adenoviral infection represents a significant health problem and there is a high medical need for an effective treatment. Currently, there is no specific anti-viral treatment available to shorten the course of infection, to improve the clinical symptoms, or to prevent the disease.

About Adenovir Pharma’s eyedrops for treatment of EKC

Adenovir Pharma is developing a topical anti-viral pharmaceutical product for treatment of EKC, by preventing adenoviruses from binding to the receptors in the human eye. The product – eye drops – acts outside the human cells which should reduce the risk of developing viral resistance.

Project status

Adenovir Pharma’s drug candidates APD-209 and APD-514 Eyedrops are concluded to be safe and well tolerated in several pre-clinical toxicity studies.

Clinical studies with APD-209 have showed that the product is safe and well tolerated.

A multi-center randomized double-masked placebo-controlled Phase 2a clinical study with APD-209 in EKC patients has been completed. The study did not give a conclusive result as the evaluable patients who met the inclusion criteria proved to be too few to show statistically significant efficacy. On the other hand, the results pointed to a number of positive trends, a decrease of the amount of virus in tear fluid as well as several important clinical symptoms and support the product hypothesis. The study also gave Adenovir Pharma many good insights and pointed to the product’s possibilities.

Discussions are ongoing concerning the further development of the clinical programs for APD-209 and the second generation candidate APD-514.

About the scientific research

The scientific research work was performed by Professor Göran Wadell MD, PhD, Professor Niklas Arnberg PhD, and others at the Umeå University in Sweden. Together with scientists at the Department of Chemistry, Lund University, Professors Olov Sterner and Ulf Ellervik together with their co-workers developed several new candidates which have been tested with positive results.