Stockholm 00 September 2021 – Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, have today announced that a product component of ensereptide has been manufactured, released according to Good Manufacturing Practice, and delivered to Promore Pharma.
Promore Pharma has partnered with Fidia Farmaceutici S.p.A. (“Fidia”) for the production of hyaluronic acid, which is one of the components of Promore Pharma's investigational drug ensereptide. Fidia is a world-leading manufacturer of pharma grade hyaluronic acid. Fidia has delivered high quality services resulting in the successful milestone being met. Ensereptide is being developed as a treatment to prevent skin scarring and post-surgical adhesions.
The manufacturing, technical release and delivery of this product component means that the PHSU05 project is on schedule. PHSU05 is a Phase II pilot study aimed at evaluating local tolerance, the application process for ensereptide and the preliminary effect of the study drug to prevent scarring after experimentally induced full-thickness wounds in healthy volunteers.
“We are well on our way in preparing a clinical trial application with the aim of starting patient enrollment during the first quarter of 2022” says Jonas Ekblom, CEO of Promore Pharma.
The company’s ensereptide program is currently focused on the prevention of skin scarring after surgery or trauma but foresees potential to also develop products based on ensereptide for other medical applications such as prevention of adhesions after tendon repair surgery and spinal surgery.
Scars arise after almost every dermal injury. While scars are often considered trivial, a notable proportion of scars can be disfiguring and aesthetically unpleasant and cause severe itching, tenderness, pain, sleep disturbance, anxiety, depression, and disruption of daily activities.
The global scar treatment market, including laser treatment, scar revision surgery and over-the-counter products, is estimated at USD 25 billion with an annual growth of approximately 10%, according to independent estimations. Today, there are no pharmaceutical prescription products available for preventing scar formation.