Pergamum AB has announced that several end-points were met in a randomized Phase II trial of PXL-01 for prevention of post-surgical adhesions. Karolinska Development AB is the majority owner of Pergamum.
Many patients undergoing hand surgery suffer from debilitating scar formation, which reduces the range of motion and complicates daily activities.
PXL-01 is a novel therapeutic peptide that has been developed with the purpose to reduce the formation of obstructing scars and restore mobility and function.
Follow-up data from the Phase II clinical trial of PXL-01 at 6 and 12 months post-surgery revealed a statistically significant improvement in functional hand recovery compared to placebo.
Treatment was not associated with any safety issues or increase in the rate of tendon rupture.
In total, 138 patients undergoing hand surgery were treated in this prospective, double-blind, randomized, placebo controlled clinical trial conducted in Sweden, Denmark and Germany. Top-line data from this study was first reported in July 2012.
“Post-surgical adhesions represent a large medical need. Pergamum’s investigational drug shows a promising and clinically relevant effect on endpoints that are important indicators of deficit in hand function after surgery”, said Associate Professor Marianne Arner, Head of the Department of Hand Surgery, Södersjukhuset, Stockholm.
“These compelling results give us the confidence to proceed with the development of the product to the orthopedic surgery segment and other indications, where adhesions and scars represent a considerable debilitating adverse effect. According to in-house estimates, the global market for surgical sealants, wound adhesives and anti-adhesives is in the excess of USD 10bn”, said Jonas Ekblom, CEO of Pergamum.
“The 6 and 12-month follow-up data from this clinical trial show a clear benefit for the patients treated with PXL-01. We strongly feel that PXL-01 has the potential of becoming the first pharmaceutical product registered to target post-surgical adhesions”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB.