STOCKHOLM, 31 March, 2021 – Promore Pharma provides clarification regarding media data on previous studies with ensereptide (PXL01) regarding skin scarring
In a commentary on today's publication of Promore Pharma's new strategy focusing on scars on the skin, the media has directed a historical review of research results published in 2012, where it was referred to that a study with ensereptide against scarring did not reach its primary goals. The company therefore wants to clarify the following:
The company has not previously conducted any study regarding the effect of ensereptide to prevent scarring of the skin. However, the company has previously conducted a clinical study with ensereptide concerning scarring between tendon and tendon sheath in the hand (PHSU02).
The company also wants to clarify that during the implementation of PHSU02, a first analysis was carried out after three months of follow-up where the primary study goal did not achieve a statistically verifiable difference between ensereptide and placebo. However, after 6 and 12 months of follow-up, it was found that the study essentially achieved its goals, including a statistically significant treatment effect of ensereptide. These results were never communicated in separate press releases since the company was not public at the time. However, these results have been published in a scientific article (Wiig et al, 2014*) and were described in Promore Pharma's prospectus** in connection with the initial public offering in 2017.
*Wiig ME, Dahlin LB, Fridén J, Hagberg L, Larsen SE, et al. (2014) PXL01 in Sodium Hyaluronate for Improvement of Hand Recovery after Flexor Tendon Repair Surgery: Randomized Controlled Trial. PLoS ONE 9(10): e110735.