STOCKHOLM, November 12, 2019 – Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, today announced that its subsidiary Pergamum AB was granted a patent in the US for the pharmaceutical formulation of the product candidate PXL01.
Promore Pharma’s subsidiary Pergamum owns the intellectual property rights of PXL01, which initially is being developed to prevent post-surgical adhesions after tendon repair surgery. The U.S. Patent Office (USPTO) issued a Notice of Allowance in June 2019 and the patent, which protects the formulation of PXL01 in combination with high molecular weight hyaluronic acid, is today formally granted (US 1 047 1129). The patent is valid at least until January 2030.
“This is an important step in our strategic work to create an extensive intellectual property protection for our innovative candidate drug to prevent post-surgical adhesions” said Jonas Ekblom, President and CEO of Promore Pharma. “In this work it is of utmost importance to have a strong patent protection on the world’s largest pharmaceutical market”, he continued.
The development of PXL01 is initially aiming at preventing postsurgical adhesions after tendon repair surgery in the hand. Post-surgical adhesions constitute a substantial clinical problem after most surgical procedures, and particularly in conjunction with hand surgery. Flexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired recovery of normal hand function. Serious tendon injuries affect more than one million persons per year in the traditional pharmaceutical markets, of which around 30% in the hand. A large share of the patients affected by serious tendon injuries never recover full mobility. Permanent limitation in mobility is particularly common after injuries in the tendons of the hand, where up to 50% of patients never recover full flexibility and strength in the hand.
For additional information, please contact
Jonas Ekblom, CEO
Phone: [+46] 736 777 540
Jenni Björnulfson, CFO
Phone: [+46] 708 55 38 05
The information was submitted for publication, through the agency of the contact persons set out above, at 16.00 CET on 12 November 2019.
Promore Pharma’s Certified Adviser is Redeye AB.
Phone: [+46] 8 121 576 90
Promore Pharma in brief:
Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides. The company’s aim is to develop first-in-category pharmaceuticals for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma’s two projects are in late stage clinical development phase and have a very strong safety profile since they are based on innate substances that are administered locally. The leading project, PXL01, that will be used for prevention of post-surgical adhesions and scars, is being prepared for clinical phase III-studies in patients undergoing tendon repair surgery in the hand. LL-37 has initiated a clinical phase IIb study in patients with venous leg ulcers (VLU). The product candidates can also be deployed for other indications, such as preventing dermal scarring, adhesions after other surgical procedures and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North Growth Market.
PXL01 is derived from a human anti-bacterial protein (lactoferrin), which is part of the innate immune system. This protein and its fragments have several modes of action, including immunomodulation and enhancement of fibrinolytic activity. It is well established that inflammation and fibrin formation after surgery are two pivotal mechanisms that strongly contribute to scar formation. The development of PXL01 is initially aiming at preventing postsurgical adhesions after tendon repair surgery. In a Phase II clinical study that has been completed by the company in several EU countries, it has been demonstrated that PXL01 is efficacious and safe. Promore Pharma is preparing for a clinical Phase III study in EU and India. The trial is planned as a randomized, double-blinded study including approximately 600 patients with flexor tendon injuries in the hand where a single administration event of PXL01 at two different doses will be compared with placebo.