Promore Pharma AB announced that the results from the company's Phase II study PHSU05 with ensereptide in prevention of skin scarring have been concluded. Results from the study show that the investigational drug ensereptide is safe and tolerable, which was the clinical trial's primary study objective. However, no clear differences in the efficacy on reducing the scarring were observed between ensereptide and placebo.

The company's most recent clinical study of ensereptide has focused on the prevention of scars on the skin associated with surgery or trauma. A total of 24 subjects have completed the study protocol in PHSU05, which is the company's Phase II study with ensereptide. At the subjects' last visit to the clinic, skin biopsies were collected.

These biopsies have been evaluated with advanced histological methods during the autumn and winter of 2022/2023. When data from the study has now been analyzed, the following main findings are concluded: The application of the investigational drug enseREptide could be administered without complications and there were no differences between the application of ensereptide and the application of placebo. No serious adverse events were reported.

There was no difference in the frequency of local adverse reactions between ensereptide & placebo. The majority of adverse events were classified as mild and unlikely to be caused by the investigational drug. There were no statistically verifiable differences between ensereptideand placebo in the secondary endpoints comprising two clinical rating scales for dermal scarring.

In the histopathological analysis of skin biopsies from the subjects, there was no clear evidence of treatment effect of ensereptide compared to placebo. The PHSU05 study was a double-blind, randomized Phase II pilot study with the goal of evaluating ensereptide regarding (i) local tolerance, (ii) the application process of the investigational drug, and (iii) preliminary efficacy regarding scar prevention after experimentally induced wounds in healthy volunteers.