STOCKHOLM, 27 February, 2023 — Promore Pharma AB announces today that the Clean File milestone has been achieved in the PHSU05 clinical trial. The publication of the results from the company's phase II study PHSU05 with ensereptide for prevention of skin scarring is expected to be available in the second half of April 2023.
The company's ensereptide program is currently focused on the prevention of skin scarring associated with surgery or trauma. During 2022, a total of 24 subjects completed the study protocol as planned in PHSU05, the company’s phase II study with ensereptide. With this clinical trial, Promore Pharma hopes to be able to demonstrate that treatment with ensereptide reduces the likelihood of scarring on the skin. At the last clinic visit, biopsies were collected and these tissue samples have been evaluated with advanced histological methods during the fall and winter. The remaining work involve statistical processing, unblinding and analysis of the study results. A read-out of results from the trial is expected in the second half of April 2023.
"Our clinical study PHSU05 has so far progressed completely according to our plan in all areas that we can influence. I am very pleased that we have reached this important milestone in the clinical trial. This means that we can determine with greater certainty that the unblinded final results from the study should be available by the end of April," says Jonas Ekblom, CEO of Promore Pharma.
The study is a double-blind, randomized phase II pilot study with the goal of being able to evaluate ensereptide regarding (i) local tolerance, (ii) the application process for the experimental drug, and (iii) preliminary efficacy regarding scar prevention in experimentally induced wounds in healthy volunteers. The clinical part of the study, which has been conducted at Clinical Trial Consultants AB's clinic in Uppsala, has been completed. 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 have been reported.
Scars appear after virtually all types of injuries to the skin. Although scars can often be considered trivial, a large proportion of them can be disfiguring and aesthetically undesirable, and they can also cause itching, stiffness, sleep problems, anxiety, depression and create a negative impact on activities of daily life.
The world market for products for the treatment of scars, including laser treatment, scar revision and self-care products, is estimated at USD 25 billion annually with a yearly growth of about 10%, according to independent estimates. Today, there are no prescription pharmaceuticals for scar prevention.