The Danish Medicines Agency and the Ethics Committee in Region Sjaelland have both given Trophea Development approval to initiate the first clinical study, a Phase I study, with an innovative combination product against skin atrophy. The clinical study will be performed at Sjaelland’s University Hospital in Roskilde in Denmark.
The development program has progressed according to plan. Trophea’s topical combination product has been developed and manufactured according to Good Manufacturing Practice (GMP), the preclinical phase has been completed and the project is now progressing into the clinical phase. The project is based on an innovative combination of two well-documented and studied substances with different mode of actions of which both seem to reverse skin atrophy.
A recognized problem in connection with long-term treatment with corticosteroids is that patients may develop skin atrophy as a side-effect. 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.
“A product that effectively can treat skin atrophy is highly asked for since there are no such treatments today. People that are at risk for developing skin atrophy, and may be helped by this new treatment, would be psoriasis, atopic dermatitis and eczema patients with long time exposure to glucocorticoids,” says Jan Faergemann, innovator and Professor in Dermatology at Sahlgrenska Academy, University of Gothenburg in Sweden.
“I am very pleased that our development program has reached this important milestone enabling us to initiate the company’s first clinical trial with Trophea topical combination gel against skin atrophy,” says Jeanette Robertsson, project leader at Trophea Development AB.
Trophea is a start-up company developing an innovative medication against skin atrophy. Trophea AB and its subsidiary Trophea Development AB were founded in 2016. The companies are part of the group of the Swedish company PULS (Partners for Development Investments in Life Sciences, P.U.L.S. AB) and are based in Helsingborg, Sweden. For further information about Trophea and the project, see www.tropheadevelopment.com.
PULS (Partners for Development Investments in Life Sciences, P.U.L.S. AB) is a Swedish life science company with a unique combination of researchers and industry representatives who work together with innovators to commercialize ideas through capital, know-how and a committed partnership. PULS invests in early projects and develops them in close collaboration with innovators, shepherding them all the way from idea to completed attractive project for industry. Since 2002 PULS has started eleven project companies: two were sold, one was discontinued, two were floated on the stock market (AcuCort and LIDDS), and one was outlicensed. PULS has its headquarters in Helsingborg. Current PULS projects: Adenovir Pharma, Belina, Glactone Pharma, Oncorena and Trophea. www.pulsinvest.se.