Trophea develops a topical product for the treatment of skin atrophy caused by long-term use of corticosteroids.
A well-known problem in connection with long-term treatment with corticosteroid creams is that the patients may develop skin atrophy as a side-effect. There is currently no effective treatment against skin atrophy. The innovator group has shown that a combination of two well-known substances increases the formation of procollagen in the skin, promoting the regeneration of the damaged atrophied skin.
Both substances are well-known and each has been studied concerning efficacy as well as safety, which means a simpler and more expedient way forward in the development work.
The largest patient population treated with strong glucocorticoids is adults suffering from severe atopic dermatitis (eczema) or psoriasis. Overall, approximately 18 million patients are treated with strong glucocorticoids for these disorders in the seven largest markets. A moderate estimate of market penetration and price of the product gives annual sales of approximately SEK one billion (EUR 100 million). There are also opportunities for a buyer of the project to expand into other types of skin atrophy, such as sun and age-induced atrophy. These are markets that are significant, but more difficult to estimate exactly today. The largest patient population treated with strong glucocorticoids is adults suffering from severe atopic dermatitis (eczema) or psoriasis. At a later stage, a combination of Trophea’s product and a glucocorticoid can also be considered.
Status of the project
A formulation, a topical gel, has been developed. Following an advisory meeting with the Swedish Medical Products Agency in June 2017, Trophea’s development plan was established. The preclinical phase is complete. When the product has been manufactured according to GMP (Good Manufacturing Practice), a clinical Phase I study in patients will be conducted to demonstrate the safety of the product candidate followed by the Phase II study. Both studies are being planned and several interested clinics with good access to patients have been identified.
Intellectual property rights
The patent application has entered national phase which means that the application has progressed from PCT to national phase in the spring of 2017.
The intention is to develop the project up to and including a Phase II study in which efficacy as well as safety can be demonstrated. Potential buyers or partners are companies that are operating on the dermatology market or have products with strong glucocorticoids.