Promore Pharma in Brief

Promore Pharma is a biopharmaceutical company that develops therapeutic peptides for the bioactive wound market. The has two therapeutic peptides, PXL01 and LL-37, in late stage clinical phase. PXL01, that will be used to prevent post-surgical adhesions and scars, is being prepared for clinical phase III-studies on patients performing tendon repair surgery in the hand. LL-37 is prepared for a clinical phase IIb study on patients with venous leg ulcers and later also a clinical phase IIa study on patients with diabetic foot ulcers.

Promore Pharma’s product candidates are based on peptides, possessing multiple biological functions and properties and are derived from sequences of human innate defense system. They are aimed for local application and have a strong safety profile since they are quickly degraded in the blood and thereby cannot contribute to severe systemic adverse events. The results from previous clinical studies are very promising for both PXL01 and LL-37, both when it comes to tolerability and safety as well as efficiency. The product candidates are protected by several international patent families with a run rate until 2030 and longer. The patents provide protection in several dimensions, such as indications, composition and dose intervals.

Promore Pharma’s product candidates represent first-in-category therapeutics for several patient groups where patients to a large extent experience pain and reduced mobility, all with high unmet need. If Promore Pharma’s product candidates in clinical development get market authorization and are established as treatment for chronic wounds and for preventing adherences and scars, it would mean shorter treatment times and improved quality of life for patients and lower costs for society.

PXL01 is derived from a human anti-bacterial peptide (lactoferrin), which is part of the innate immune system, with several modes of actions. The development of PXL01 is initially aiming at preventing postsurgical adhesions after tendon repair surgery. Promore Pharma is preparing for a fully financed clinical phase III study in EU and Asia. A parallel clinical phase III study is planned in the USA, to form the basis a market authorization in North America. The company is initially focusing on preventing post-surgical adhesions after tendon repair surgery but assume there are good opportunities for indication broadening, such a preventing dermal scars and adhesions after total knee arthroplasty.

LL-37 is based on a human antimicrobial peptide, which stimulates several processes in wound healing. LL-37 showed good efficacy in the clinical phase IIa study performed. The product candidate can be combined with standard treatment and used by nurses or potentially the patient. The development of LL-37 is focusing on venous leg ulcers and in the next stage diabetic foot ulcers. LL-37 is being prepared for a clinical phase IIb study on patients with venous leg ulcers in Europe in co-operation with PRP, Promore Pharma’s partner. A smaller investigator sponsored trial is planned for LL-37 in diabetic foot ulcers.

The company’s aim is to develop two first-in-category productswith uses in broad applications in bioactive wound care, specifically in indications with very few efficacious prescription pharmaceuticals addressing high unmet medical need. Promore Pharma is a small and cost-efficient company without own laboratories or research facilities, using a net-work of high-quality contract research organizations and contract manufacturing organizations. The company has aggregated a number of advisors that are providing their specific input in all critical aspects of the strategic planning, including product development, regulatory affairs, design and execution of clinical trials.

Promore Pharma’s overall strategy is to take the product candidates through clinical development to market authorization or to a license agreement, alternatively a commercial deal with a larger pharmaceutical company with global presence can be reached. Such deals may involve Out-partnering/licensing, Strategic partnerships or joint ventures or Asset sales.