STOCKHOLM, 13 June 2022 – Promore Pharma AB announces today that the last clinic visit has been carried out for the subjects who participated in the company's phase II study PHSU05 with ensereptide against skin. The target of 24 treated patients with ensereptide has been reached, and these subjects have been monitored during three months after the incision. The company estimates that results from the study can be presented around the turn of the year 2022/2023 according to the previously communicated plan.
The company's ensereptide program is currently focused on the prevention of skin scars associated with surgery or trauma. The goal of Promore Pharma's Phase II study with ensereptide, PHSU05, was that approximately 20 patients would undergo the entire study protocol. The company announces today that a total of 24 patients have undergone the study protocol. Promore Pharma hopes that the study will be able to show that treatment with ensereptide reduces the likelihood of scarring on the skin.
“We are very content that we were able to complete the treatment of patients in the study in accordance with our business plan. It is satisfactory that no patients have experienced serious side effects associated with ensereptide during the treatment period”, says Jonas Ekblom, CEO of Promore Pharma. "Work on the study will now continue during the second half of the year and our goal is to be able to unblind the study results around the turn of the year," he continues.
The study is a double-blind, randomized phase II pilot study with the aim of being able to evaluate ensereptide regarding (i) local tolerance, (ii) the application process of the experimental drug, and (iii) preliminary effect on scar prevention after experimentally induced wounds in healthy volunteers. The study is conducted at the University Hospital in Uppsala, and the goal has been to include 24 subjects. Treatment with ensereptide or placebo takes place on a single occasion, in connection with the surgical procedure, and the subjects were then followed for approximately 13 weeks. At the last clinic visit, biopsies were collected which will be evaluated using advanced histological methods during the autumn of 2022. A final study report with results from the study is expected in the winter of 2022/2023.
Scars appear after virtually all types of damage to the skin. Although scars can often be considered trivial, a large proportion of them can be disfiguring and aesthetically pleasing, and they can also cause itching, stiffness, sleep problems, anxiety, depression and create a negative impact on activities of daily living.
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 with an annual growth of about 10%, according to independent estimates. Today, there are no prescription pharmaceuticals for wound prevention.