Micreos has raised €12 million ($13 million) to advance its enzyme-based approach to killing bacteria into clinical trials. The drug, Staphefekt, has a different killing mechanism than traditional antibiotics, which Micreos thinks enables it to take out resistant strains of Staphylococcus aureus while leaving other bacteria unharmed.
Development of Staphefekt is underpinned by research into bacteriophages, a group of viruses that replicate inside bacteria. Once the phages have replicated, they release enzymes to cut open the cell wall of the bacteria, freeing them to find and infect new hosts. The use of these enzymes, known as endolysins, to kill bacteria is the defining idea of Micreos' R&D program. Micreos initially focused on over-the-counter drugs, leading to the release of topical treatments for eczema, acne, rosacea and skin irritation, before rounding up the cash it needs to go after the prescription product market.
Both sides of the business are underpinned by the same concept. "The lysin technology we are practicing, where we produce what are called chimeric enzymes, are basically a collection of enzymes selected to target those areas of the Staphylococcus aureus cell wall that are specific and essential to that bacterial species," Micreos CEO Mark Offerhaus told FierceBiotech. "Because this killing mechanism is completely unrelated to the killing mechanism of antibiotics, it is just as effective against antibiotic-resistant strains as non-resistant strains."
The Hague, Netherlands-based Micreos is optimistic that bacteria won't develop resistance to its approach, a position that is based on preclinical data and a belief that a billion years of evolution has resulted in endolysins that target essential, hard-to-change parts of the cell wall. Similarly, Micreos has clinical data suggesting its product is a more targeted way of killing bacteria. While penicillin, for example, kills gram-positive bacteria indiscriminately, trials of Staphefekt suggest it reduces levels of S. aureus without affecting the rest of the skin microbiota.
Work is now underway to generate such data in more rigorous, double-blind randomized trials. "The preclinical and GMP work will be conducted in 2016," Offerhaus said. "Then, we'll start a combined Phase I and II trial in 2017." Micreos is looking to develop Staphefekt as a treatment for eczema, diabetic wound infections, ulcers and burn wounds. And, if the product is as specific and free from resistance concerns as Micreos thinks, it could find a role in the sorts of daily maintenance regimens for which traditional antibiotics are ill-suited.
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