PHILADELPHIA & SYDNEY—This year's meeting of the American Society for Microbiology, ASM Microbe 2019, featured presentations by several companies, among them Botanix Pharmaceuticals Limited. The company focuses on the potential of cannabinoids in drug development, and in one of the more unusual applications, shared data at ASM Microbe 2019 of the potential of cannabidiol in targeting infections. The data came from studies conducted of BTX 1801 in collaboration with Dr. Mark Blaskovich at The University of Queensland’s Institute for Molecular Bioscience’s Centre for Superbug Solutions.
“The pipeline of new antibiotics in clinical development is way too small to combat the growing threat of antimicrobial resistance. Most of these agents are really only modifications of existing antibiotics and will not provide long-term solutions to the problem,” said Blaskovich. “It is not surprising that the United States Food and Drug Administration have recently provided companies with attractive incentives to develop new antibiotics including expedited review of drug applications and introducing the qualified infectious disease products designation program which allows companies to gain an extra five years marketing exclusivity following drug approval.”
BTX 1801 is a novel topical formulation of cannabidiol—the non-psychoactive chemical compound found in cannabis and hemp plants—that uses Permetrex, Botanix's proprietary skin delivery technology, to target bacterial infections in the skin. These latest studies confirmed that cannabidiol could be used as a broad-spectrum Gram-positive antibiotic and that BTX 1801 specifically has such potential against skin infections.
BTX 1801 demonstrated potency similar to that of vancomycin and daptomycin when deployed against Gram-positive bacteria, and was found to be effective against clinical isolates of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) as well—when tested against a panel of 132 such isolates, cannabidiol proved effective against all isolates even at low concentrations. In addition, the candidate proved effective in a proof-of-concept animal wound model of skin infection and displayed broad anti-inflammatory properties.
Perhaps the most compelling result is that based on the studies so far, bacteria don't form resistance to cannabidiol. The compound was tested in industry-standard repeat challenge tests, and even after 21 days of continuous treatment, MRSA bacteria did not develop resistance to cannabidiol. Key to this benefit is likely cannabidiol's mechanism of action. Unlike many antibiotics, cannabidiol is bactericidal, not bacteriostatic, meaning that it kills bacteria rather than simply stopping it from reproducing—and kills it in less than three hours. Bacteria have biofilms that surround them and offer protection from antibiotics, and cannabidiol is capable of disrupting these biofilms.
“Given cannabidiol’s documented anti-inflammatory effects, existing safety data in humans, and potential for varied delivery routes, it is a promising new antibiotic worth further investigation,” Blaskovich remarked. “The combination of inherent antimicrobial activity and potential to reduce damage caused by the inflammatory response to infections is particularly attractive.”
Moving forward, Botanix will be working to optimize the dosing strategy for BTX 1801 for clinical development and advance the compound into a clinical study in a skin infection indication.
Matt Callahan, founder and executive director of Botanix, noted in a statement that, “The implications and potential applications of these remarkable results are immense. This new data significantly expands the potential for BTX 1801, to not only serve as a powerful new antibiotic option for patients and doctors, but provides further confirmation antimicrobial activity may be a significant contributor to the overall efficacy of Botanix’s Phase 2 products for acne (BTX 1503) and atopic dermatitis (BTX 1204). The fact that cannabidiol kills resistant bacteria quickly, when combined with the drug’s newly validated anti-inflammatory properties, gives us confidence that BTX 1801 has significant potential as a powerful new antimicrobial for use in skin and other infections.”