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SA.100: Next-generation targeted antibacterial product entering European market

Periodic Reporting for period 2 - StaphIMPACT (SA.100: Next-generation targeted antibacterial product entering European market)

Reporting period: 2020-07-01 to 2021-12-31

According to the WHO, antibiotic resistance is one of humanity’s biggest health threats, claiming ~10 million extra deaths per year and US$100 trillion by 2050, unless alternatives to antibiotics are developed. Micreos has developed the world’s first targeted antibacterial products, set to replace antibiotics. With its endolysin technology, for the first time it is possible to kill only the unwanted bacteria, regardless of resistance. Micreos’ endolysin technology was chosen as Europe’s most relevant Innovation 2018 (Ideas from Europe). Its first lead endolysin, SA.100 kills only Staphylococcus aureus, including the resistant MRSA. Soft-launched under the Gladskin brand in the Netherlands, it’s having life-changing impact for thousands of people with inflammatory skin conditions caused or aggravated by S. aureus, including eczema, acne, rosacea and Hyper IgE syndrome. Micreos also develops products for diabetic wound infections and a skin cancer triggered by S. aureus. Micreos owns all relevant IP and know-how on its technology and produces its compounds and Gladskin products at small-scale at its facilities in the Netherlands. With this SMEi, Micreos prepares for full roll-out into the EU markets of its SA.100/Gladskin. This includes scale-up of production capacity, strengthening clinical evidence and communication of results to KOLs and relevant stakeholders. Leading pharma and cosmetics companies have expressed interest to in-license Micreos’ technology for particular indications. Relevant markets are the consumer’s skin care market ($177b by 2024; CAGR 4.7%) and dermatology market ($19.8b by 2023; CAGR 9.1%.). Own contribution by Micreos for this SMEi is already secured. This SMEi enables Micreos to take final steps for EU-wide roll-out, driving employment growth and company profitability, and helping people suffering from inflammatory skin conditions.
Scale up of the production process of the SA.100 (active ingredient) and Gladskin (final product formulation) has been finalized, providing the material for further roll-out of Gladskin throughout Europe. A licensing agreement has been established with L’Oréal and introduction of the product in their portfolio has taken place. The manufacturing expansion has provided the license partner with product to allow for an early introduction of their product in the market. Market access research has been done and commercial plans based on this are being executed. This has led to a significant pick up of sales in the countries targeted so far.

For the formulation extension a scalp spray product has been developed which is now ready to enter into the stability and compatibility phase which is the last step towards commercialization. This phase will be initiated when the first commercial batch has been manufactured.
There is an imminent need for alternatives to antibiotics, in this era of antimicrobial resistance. However, pipelines of pharma companies are empty, and several top-10 companies abandoned their antibiotics programs due to lack of new candidates, poor efficacy, and shelfing of any new antibiotics (to preserve their efficacy given the expected rapid emergence of resistance). In addition, the need to leave the microbiome intact provides a hurdle for successful antimicrobial product development. Clearly a different approach is needed. The use of endolysins and bacteriophages as targeted approaches, such as Gladskin, can fill this void.

Gladskin has been made available throughout Europe. It has shown benefit in patients suffering from eczema, rosacea, acne and shaving irritation. Several advantages over the current state of the art OTC treatments for these indications make it highly attractive. During this project the efficacy of Gladskin in eczema is further established and has entered the European market.
Visual representation of Micreos’ endolysin technology