PXL-01

The Challenge

Post-surgical adhesions are scar tissues that frequently develop after many types of surgery. The adhesions are a response of the body's repair mechanism to the tissue damage caused by surgical trauma.  Depending on the location where the adhesions occur, they can cause symptoms such as chronic pain, reduced mobility and function, intestinal obstruction and infertility.

Pergamum's Solution

PXL-01 is an antimicrobial peptide derived from the human milk protein lactoferrin.  It has been demonstrated in animal studies that local administration of PXL-01 significantly reduces the formation of adhesions during the healing phase of surgical wounds. The anti-adhesive effect of PXL-01 is linked to its ability to reduce the inflammatory response and its fibrinolytic capacity.

Competitive Advantages

There is no pharmacological treatment registered for adhesion prevention.  All treatments currently in use act by physically separating damaged tissue surfaces and they are registered as medical device products. PXL-01 could potentially be the first pharmacological treatment for adhesion prevention.

PXL-01 has been shown to have antimicrobial effects, with the potential to reduce the risk of infection. The compound is formulated as a lubricating gel that provides controlled release of the peptide, combining the pharmacological effects of PXL-01 to prevent adhesion with the physical barrier effect of the barrier gel compound (sodium hyaluronate). The product is administered in the area of the flexor tendon during surgery.

The Market

The market for the prevention of post-surgical adhesions can be divided into segments by surgical specialty: Orthopedic, abdominal/pelvic, cardiac, sinus surgery, and surgery of the peripheral nervous system. In the EU and the US alone, about eight million procedures in these fields could benefit from adhesion-prevention products. The company estimates the total relevant market size to be in excess of EUR 1.6 bn¹. However, all current products are registered as medical devices. The orthopedic surgery segment offers a particularly attractive market as a result of large numbers of patients and high occurrence of complications due to adhesions and homogeneous product requirements.

Status

• The effect of PXL-01 in sodium hyaluronate on adhesions associated with flexor tendon repair procedures was studied in a rabbit model (see diagram below). PXL-01 treatment resulted in completely normal joint mobility after surgery. Animals undergoing surgery without protection with PXL-01 developed significantly reduced joint mobility as a result of adhesions.
• A Phase I study showed that the drug candidate PXL-01 is safe and well-tolerated
• 138 patients have been included in a Phase II study for proof-of-concept of PXL-01 for prevention of post-surgical adhesions after flexor tendon repair surgery. The patients are being followed for a 12 week period.