Opportunity

The Need


Various wound conditions account for millions of deaths worldwide each year and trigger tremendous healthcare costs – more than 4 billion EUR a year in USA and Europe. It accounts for almost 4% of total health system costs, and this proportion is increasing, thus representing a significant and growing challenge to our healthcare systems.

Any damage to the skin barrier imposes a risk of infection and requires anti-infective treatment. Antimicrobial resistance (AMR) to antibiotics increases, and other anti-infective treatments available have various negative side-effects. Therefore, new cost-efficient non-antibiotic treatments are needed.

The Market


We are initially targeting the rare skin disease Epidermolysis Bullosa. Xinnate´s other projects in pipeline target patient populations and procedures in need of the most advanced treatments for wounds and dysfunctional inflammation.

Wounds and injuries are one of the most common health conditions, effecting billions of people globally. Millions of people suffer from trauma and burns as result of accidents and violence and still more people acquire wounds due to complications from diabetes, obesity and cardiovascular diseases. Particularly the acquired types of wounds are estimated to increase dramatically, as more people will suffer from chronic conditions leading to wounds, and also as a result of an increasing aging population that are susceptible of acquiring wounds.

The total global wound care market is expected to reach EUR 18 Billion by 2022 from EUR 15 Billion in 2017, a  calculated annual growth of 3.7%. The advanced wound care market, which is our primary target market, is estimated to  EUR 7 Bio. The primary need in this industry is to decrease the dependency on antibiotics and on the questioned antiseptic substances and to focus on sustainable solutions with a proven efficacy. Based on the unique mode of action we believe that BioC gel could claim that space and that the Xinnate product portfolio will be able to cover a market of at least 1 billion Euro.

Examples:

1. Surgical infections affects 30-40 patients per 1000 operations, leading to prolonged hospital stay by 11 days and increase in hospitalization costs by 20%, according to European data. The mortality rate in wound infection is 5%.

2. Acute burn wounds requiring medical treatment affect more than half a million Americans each year, resulting in 400000 hospital stays and 4000 deaths. The annual cost of treating these burns is estimated to be in excess of USD 1bio not including the indirect costs of disability and rehabilitation.

The Unique Concept


The Xinnate concept is based on our patented TCP-25 platform, a peptide which is part of the human natural defence system. The mode of action is very well understood and published in high impact journals such as Nature Communications.  The uniqueness of the TCP-25 based drug is threefold.

A

BioC has a broader biological effect than currently used drugs – it targets both inflammation and infection.

B

BioC is effective also on multiresistant bacteria, i.e. bacteria that are resistant to antibiotics. Because of its mode of action, BioC is unlikely to cause bacterial resistance.

C

BioC is part of our own natural defence system and is therefore unlikely to be harmful for the patient or the environment. It therefore has a clear potential to replace and reduce the use of other substances with negative side effects.

A. Targeting inflammation and infection

There is a great and unmet need for new innovative products that can both reduce inflammation and prevent infection. Any damage to the skin barrier imposes a risk of infection. In severe cases, bacteria can be released into the bloodstream and released endotoxins can cause an excessive and sometimes lethal inflammatory response, i. e. sepsis. Today´s treatments, targeting microbes with antibiotics, are only able to remove the invading bacteria, but they don’t address the inflammation.

Figure 1 – Illustration of the mode of action of BioC hydrogel. BioC scavenges endotoxins and binds to bacteria, leading to reduced inflammation but with retained bacterial and toxin clearance. Inflammation is therefore controlled. BioC in the hydrogel has a direct killing effect on bacteria in addition.

Anti-inflammatory – naturally managing the paradox keeping the initial healthy level of inflammation and quenching the excessive damaging systemic inflammation. Inflammation is a natural reaction during healing but in the presence of bacteria, bacterial endotoxins or other pro-inflammatory substances, uncontrolled and excessive inflammation can cause impaired healing. Therefore, targeting inflammation in combination with infection will decrease healing time and improve end result.

Anti-infective – for prevention and early treatment of infections. It is effective on both gram-positive and gram-negative bacteria and also on drug resistant bacteria. Infection related diseases are causing millions of deaths and entails huge costs worldwide and this will increase.

Dual effect – no drug with a similar dual effect exists today, and this broad biological effect enables an extensive range of target indications, such as inflammatory skin diseases, acute and chronic wounds, but also other applications such as post cosmetic treatment and coatings of surgical sutures and other biomaterials in skin contact (catheters, ostomy, skin replacement materials)

B. Replacing and reducing the use of antibiotics

Infections are typically prevented and treated with antibiotics. The excessive utilisation of antibiotics, however, has generated an increasing range of bacteria that are resistant. This means, that in the future there will be infections where antibiotics are not effective, and that we in the future will have to restrain the use of the remaining effective antibiotics to the most critical situations. The expected future limited efficiency and availability of antibiotics will mean that preventive care will become increasingly important – we therefore need more efficient and sustainable drugs that target infection and, maybe more importantly, inflammation at an early stage.

C. Replacing and reducing the use of other anti-infective substances with negative side effects

Current topical wound treatments are based on anti-infective components (iodine, silver, PHMB). These substances are all, in different ways, potentially harmful for the environment and/or the patient. There is thus a need to replace the current use of antiseptic treatments with more efficient alternatives without negative side effects.

The Competition


There is no effective drug available with the dual effect of both antibacterial and anti-inflammatory. The benchmark treatment options are antibiotics and topical treatments based on anti-infective components (iodine, silver, PHMB).

Each of these treatments have built-in risks, either for the patient, the environment or both. A peptide such as TCP-25, identical to the ones in the body’s own defence system is very likely to neither cause bacterial resistance nor have any negative side effects for the patient or the environment.

Anti-infectiveBroad spectrumAnti-inflammatoryAnti-coagulativeEndotoxin blockingRisks
AntibioticsYesNoNoNoNoResistance development Toxicity (some)
AntisepticsSilverYesYesNoNoNoToxicity
Environmentally harmful
PHMBYesYesNoNoNoCarcinogenic
TriclosanYesYesNoNoNoToxic and Carcinogenic
Hormone-disturbing
Environmentally Harmful
BioCYesYesYesYesYesLow