Pergamum AB |
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Concept Development |
Lead Discovery |
Lead Optimization |
Preclinical Development |
Phase I |
Phase II |
Phase III |
Launch |
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Project: LL-37 |
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LL-37
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The Challenge
Venous leg ulcers are hard-to-heal wounds. An important factor in the development of venous leg ulcers is increased blood pressure in the tissues caused by impaired function of the veins. The result is leg swelling and skin damage, which eventually can lead to the formation of ulcers. The main current treatment of leg ulcers is compression bandaging, which results in healing in about 50 % of patients within 5 months1. In some cases, the ulcers fail to heal for years.
Pergamum's Solution
LL-37 is a multifunctional antimicrobial peptide, structurally derived from the C-terminal portion of human cathelicidin antimicrobial protein 18 (hCAP18). LL-37 is rapidly produced in damaged skin and is an important component in normal wound healing. The peptide has beneficial effects on various parts of the healing process, by affecting the formation of new skin cells and blood vessels. Reduced quantities of LL-37 are produced in venous leg ulcer tissue. Therefore, the addition of synthetic LL-37 has the potential to promote healing of these ulcers. Preclinical studies in diabetic mice have shown that local treatment with LL-37 resulted in significantly improved wound healing.
Competitive Advantages
LL-37 has unique wound healing and antibacterial effects not offered by any available treatments. LL-37 is formulated as a viscous solution. This formulation offers the following advantages that are essential in clinical practice:
- Controlled dose
- Simple and rapid application
- Compatible with standard dressings
- Low production costs
The Market
Between 13 and 18 million patients have hard-to-heal ulcers in the developed world2. Approximately two out of 1,000 individuals have chronic leg ulcers below the knee3 with disease duration of at least six weeks4. Venous leg ulcers constitute the largest segment among these, approximately 40-60 %3. Additional segments include arterial, diabetic, and multifactorial ulcers, each of which represents 10–20 % of the total incidence. Total sales of advanced wound healing products exceed EUR 5bn and are growing by approximately 10% annually3.

Despite limited clinical efficacy, medical device products dominate the market for advanced wound treatment. Only one globally launched pharmaceutical product (Regranex®) is on the market, with global annual sales exceeding EUR 100m. However, this product has a "black-box-warning" since 2008 after an increase in cancer mortality was observed. Regranex® is only approved for treatment of diabetic foot ulcers. Pergamum estimates the peak sales potential of LL-37 for chronic leg ulcers to exceed EUR 500m annually on the combined major markets (US, EU5, and Japan).
Status
- Proof-of-principle has been achieved in vivo
- No safety problems noted in studies carried out to date including a pivotal GLP toxicology study
Planned Milestones
- Start of Phase I/ II study to achieve safety and early efficacy data
Patent status
The company has two patent families which include the lead product. The first of these two has been approved in the US, Japan, China and South Africa, and is shortly expected to gain approval in Europe. The second patent is pending approval.
Commercialization
Pergamum intends to develop the lead product to at least clinical proof-of-concept. After this, a strategic partnership will be established with one or more companies that have a strong presence on the wound healing market.
- Source: Bjellerup. Determining venous incompetence: a report from a specialised leg ulcer clinic. Journal of Wound Care 15 (10): 429-436, 2006
- Source: Med Market Diligence, Worldwide Wound Management, 2009
- Source: Espicom, The Global Advanced Wound Care Market to 2015, 2010
- Source: Forsgren, Fransson and Velzén. Leg Ulcer point prevalence can be decreased by broad-scale intervention, Acta Dermato-Venerologica, 88(3): 252-256, 2008
| Contact Pergamum AB: Jonas Ekblom, CEO | +46 8 524 89 101| jonas.ekblom@pergamum.com | www.pergamum.com |
