Promore Pharma AB announced that the results from the company's phase II study PHSU05 with ensereptide for prevention of skin scarring is expected to be available in April 2023. The clinical part of the trial was completed according to plan earlier this year, but the limited availability of qualified personnel and specialized image analysis equipment results in a slightly longer duration of the subsequent histopathological analysis than originally expected. The company's ensereptide program is currently focused on the prevention of skin scarring associated with surgery or trauma.

In the spring, a total of 24 subjects completed the clinical study protocol according to plan in the phase II study with ensereptide, PHSU05. In this study, Promore Pharma hopes to demonstrate that treatment with ensereptide reduces the likelihood of scarring on the skin. At the last clinic visit, biopsies were collected that are being analyzed with advanced histological methods during the autumn and fall of 2022/2023.

However, the limited availability of qualified personnel and specialized image analysis equipment has caused a few weeks' shift in the original timeline. A final study report with results from the trial is expected in April 2023. The study is a double-blind, randomized phase II pilot study with the aim of evaluating ensereptide regarding (i) local tolerance, (ii) the application process for the experimental drug, as well as (iii) preliminary effect on scar prevention in healthy volunteers with experimental wounds.

The clinical part of the study that was conducted at the Clinical Trial Consultants AB's clinic in Uppsala was completed and a total of 24 subjects were included. Analysis of monitoring data from the clinical part of the study shows that the number of deviations from the study protocol has been few, and no major deviations were reported. The company expects to reach the milestone of Clean File in the project during the first quarter of 2023, which will be announced by the company.

At that time, the timeline for subsequent work with the aim of achieving an outcome report can be determined with higher precision.