Pergamum AB has announced top-line results from the randomized first time in patient Phase II trial of PXL-01 for prevention of post-surgical adhesions.
The study showed that the drug was safe and well tolerated. The primary end point of the study was not met.
However, the data suggests that PXL-01 may improve the postoperative outcome regarding the hand mobility after surgery.
Top-line results from the Phase II trial on subjects that have undergone tendon repair surgery in the hand have now been analyzed.
Treatment with PXL-01 was well tolerated, and did not adversely affect tendon or wound healing.
The study did not show any statistically significant difference between the group that were treated with PXL-01 and the placebo group measured as TAM2 (Total Active Motion, sum of two finger joints), which was the primary end point.
However, there is a clear trend that treatment with PXL-01 may improve the postoperative outcome as the number of patients categorized as having good or excellent mobility of the injured finger 12 weeks after the surgery, was higher compared to treatment with placebo.
In the group treated with PXL-01, 67 percent of the subjects demonstrated excellent or good range of motion according to Strickland’s classification scale, compared to 48 percent of the subjects in the group treated with placebo. This endpoint is an important indicator of deficit in hand function after the surgical procedure.
In total, 138 patients undergoing hand surgery was treated in this prospective, double-blind, randomized placebo controlled clinical trial conducted in Sweden, Denmark and Germany.
The final Phase II report is expected to be published in the third quarter 2012 while the trial continues to include 6 and 12 months follow up.
Jonas Ekblom, CEO of Pergamum: “Adhesion formation after surgery is a considerable debilitating adverse effect and there are currently no pharmacological products for treatment of these complications. We are now analyzing this complex data set to decide on the next step in the PXL-01 clinical program. We are looking forward to concluding the study in February 2013 including follow up data and are hopeful that the positive trends observed will continue.”
According to a recent article published in The Lancet, there are more than 230 million surgical procedures performed in the world annually and in many of these cases the patients are at risk for the formation of surgical adhesions.
Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB: “This is a study on patients after hand surgery, but there are several types of surgery where patients frequently experience complications with adhesions. These undesirable adverse effects are both painful for patients and costly for society, why an effective pharmaceutical product targeting post-surgical adhesions would have great medical and commercial potential. We will await the full analysis of this data before we make any further conclusions.”