Breye Therapeutics ApS

The Company, Breye Therapeutics ApS, is a clinical stage biopharmaceutical company developing first-in-class and orally administered therapies suited for early treatment intervention in patients with diabetic retinopathy (DR) and age-related macular degeneration (AMD) being at risk of further disease progression and vision loss.Diabetic retinopathy is the leading cause of blindness among working age adults and AMD is the leading cause of blindness within the elderly population. Globally there are more than 120 million people suffering from DR and 200 million people have AMD. With more than 1 billion people being obese today and 20% of the world’s population being older than 60 years of age, both eye diseases are projected to increase in prevalence over the coming decades. Currently available therapies require needle injections administered directly into the eye, and despite the burden of repeated needle injections, the market for these therapies has grown to USD 15 billion annually. The prospect of developing orally administered therapies could help very large groups of patients in need of better and non-invasive therapies. The ambition is to treat patients at moderate to severe stages of disease and thereby help prevent further disease progression to irreversible eye damage and the need for needle injections administered into the eyes.The company's lead therapy, danegaptide, is a clinical asset with a documented safety profile in human trial subjects and has been in licensed from Zealand Pharma A/S. It is a small molecule suitable for oral therapy which can uniquely address a large and growing unmet medical need for more effective and less burdensome therapies for patients with DR. The Company has advanced this asset into clinical testing in patients with DR and is preparing for phase 2 clinical testing. A second therapeutic program was aquired from Golgi Neurosciences S.r.l. which is in pre-clinical testing with the target of developing an oral medication for patients with AMD.During the reporting period the Company has demonstrated pre-clinical proof-of-concept in models of AMD.The Company, Breye Therapeutics ApS, has an experienced management team within drug development and is working with world leading scientists and retinal specialists to advance its early portfolio of products.