Aresus Pharma GmbH, a company of the DERMAGO Group, is pleased to announce the inclusion of the first patient in its Phase III clinical trial with the active ingredient Sinecatechins (synonyms: green tea extract, Polyphenon® E) in the indication actinic keratosis.
The study, entitled ‘Exact-1: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients with Actinic Keratosis of the Scalp and the Face’ (EXACT-1 EU CT: 2022-502811-12-00), will enrol approximately 280 patients in 9 study centres in Germany.
‘The inclusion of the first patient in our EXACT-1 study with the innovative compound sinecatechins is an important step towards developing further therapeutic options for the treatment of actinic keratoses and I would like to thank all study participants for their support,’ says Sven Schimansky-Wabra, CEO of Aresus.
With the inclusion of the first patient in the study, which is co-financed by Aresus’ distribution partners, Aresus will receive a milestone payment of an undisclosed amount.
Actinic keratoses (AK), which are considered a precursor of squamous cell carcinoma or very early squamous cell carcinoma, are among the skin diseases frequently treated by dermatologists. ‘In the last decade, a significant increase in AK has been observed. In addition to aetiological factors such as chronic UV exposure, this is due to demographic change with a higher proportion of older people. It is estimated that 1.7 million people in Germany are currently undergoing dermatological treatment for AK. However, the number of patients actually suffering from AK is much higher and will continue to rise in the coming years in line with the population structure. ‘1
1S3 guideline Actinic keratosis and squamous cell carcinoma of the skin long version 1.1 – March 2020, AWMF register number: 032/022OL