Major Milestone in the Clinical Development of Sinecatechins (Polyphenon® E)
Aresus Pharma GmbH, a company of the DERMAGO Group, announces that approximately 60% of the planned patients have been enrolled in its Phase III EXACT-1 study of the active ingredient sinecatechins (synonyms: green tea extract, Polyphenon® E) for the treatment of actinic keratosis.
The study, titled “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), a total of approximately 280 patients are to be enrolled at nine study sites in Germany.
EXACT-1 is designed as an adaptive Phase III study. Following the enrollment of approximately 60% of the patients (about 168), a pre-planned interim analysis is currently being conducted as part of this adaptive design. It serves to evaluate the progress of the study as scheduled; results are not yet available and will be communicated in due course.
“With approximately 60% of patients enrolled and the scheduled interim analysis now underway, EXACT-1 has reached an important milestone. I would like to thank all study participants, the trial sites, and our partners for their outstanding collaboration,” says Sven Schimansky-Wabra, CEO of Aresus.
The clinical development of Sinecatechins for the treatment of actinic keratosis is supported by preclinical research: In an in vitro study conducted jointly with Charité – Universitätsmedizin Berlin (research group led by PD Dr. J. Eberle / Prof. Dr. E. Stockfleth) and the European Skin Cancer Foundation, Polyphenon® E demonstrated concentration-dependent inhibition of cell proliferation and a reduction in cell viability in cutaneous squamous cell carcinoma cell lines. The results were published in 2022 in the peer-reviewed journal Antioxidants.²
Actinic keratoses (AK), which are considered a precursor to squamous cell carcinoma or a very early form of squamous cell carcinoma, are among the skin conditions most frequently treated by dermatologists. Over the past decade, a significant increase in AK has been observed. The cause of this—in addition to etiological factors such as chronic UV exposure—is demographic change, with a growing proportion of older people. It is estimated that approximately 1.7 million people in Germany are currently undergoing dermatological treatment for AK; the actual number of affected individuals is significantly higher.¹
Veregen® is currently approved for the topical treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients aged 18 and older. Global distribution partnerships are in place for more than 20 countries. Veregen® is currently undergoing clinical trials and is not yet approved for actinic keratosis.
¹ S3 Guideline on Actinic Keratosis and Squamous Cell Carcinoma of the Skin, Long Version 2.0 – March 2022, AWMF Registration Number: 032/022OL
² Zhu, J. et al. Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential. Antioxidants (Basel) 2022, 11(7), 1416. doi.org/10.3390/antiox11071416
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