STOCKHOLM, 16 February 2022 – Promore Pharma AB, a Swedish biopharmaceutical development company focusing on therapeutic peptides, announces that the first subject has been included in the company's phase II study (PHSU05) with the company's drug candidate ensereptide for the prevention of skin scarring.
In accordance with the schedule that the company presented in connection with the rights issue in the spring of 2021, the first patient has now been included in the study (PHSU05). 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 of the experimental drug, and (iii) preliminary effect on scar prevention after experimentally induced wounds in healthy volunteers. The study is conducted at the Uppsala University Hospital, and the goal is to include 24 subjects. Treatment with ensereptide or placebo takes place on a single occasion, in connection with the surgical procedure, and the subjects are then followed for about 13 weeks. At the last clinic visit, biopsies are collected which will then be evaluated using advanced histological methods during the autumn of 2022. The final study report with results from the study is expected in the winter of 2022/2023.
"I am very happy that the first patient was recruited in the PHSU05 study," said Professor Margit Mahlapuu, CSO of Promore Pharma. "The need to develop new strategies and treatments that prevent scarring is very important," she continued.
The company's ensereptide program is currently focused on the prevention of skin scarring in conjunction with surgery or trauma, but there is also potential to develop the product for other medical applications such as prevention of tissue adhesions after hand and spine surgery.
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 undesirable, and they can also create itching, stiffness, sleep problems, anxiety, depression and negatively affect activities of daily living.
“This is an important step in our long-term goal of developing a new product concept to prevent the appearance of post-surgical and post-traumatic scars on the skin. This milestone is completely in line with our business plan in the ensereptide project, despite the challenges of conducting clinical trials during the COVID-19 pandemic," says Jonas Ekblom, CEO of Promore Pharma.
The world market for products for the treatment of scars, including laser treatment, scar revision and self-care products, amounts to USD 25 billion with an annual growth of about 10%, according to independent estimates. Today, there are no prescription drugs for wound prevention.