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Promore Pharma has reached recruitment goal in clinical trial of ensereptide

STOCKHOLM, 17 March 2022 – Promore Pharma AB, a Swedish biopharmaceutical development company focusing on therapeutic peptides, announces that the recruitment goal has been accomplished according to plan 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.

"We are very hopeful that ensereptide can be developed into a unique and innovative product for prevention of various forms of scars. It is very satisfying that we have succeeded in the completion of patient enrolment into our clinical trial in accordance with our plan”, said Jonas Ekblom, CEO of Promore Pharma.

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.

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.