Journal article | “The antimicrobial potential of cannabidiol”

An important research project testing the targeted capabilities of our antimicrobial platform, conducted in collaboration with The University of Queensland, has been published in Communications Biology ­– a leading peer-reviewed journal by Nature Research.

The research article titled “The antimicrobial potential of cannabidiol” reveals the unique mechanism through which synthetic cannabidiol can kill the bacteria responsible for gonorrhoea, meningitis and legionnaires disease – a world first.

  • Read today’s ASX release here
  • Read the journal article here
  • Watch video produced by UQ here

All research data generated is fully-owned by Botanix and the subject of several patent applications,and it culminates significant collaborations involving respected antimicrobial researchers from around the world. The lead author is Dr Mark Blaskovich, Director of the University of Queensland’s Centre for Superbug Solutions in the Institute for Molecular Science, and it is co-authored by Botanix Directors Matt Callahan and Dr Michael Thurn.  

This is truly exciting for our antimicrobial platform. This new data demonstrates our potential to develop novel structural analogs of cannabinoids with increased antimicrobial activity providing a foundation for the development of a whole new class of antimicrobials.

The news comes as we are finalising data for our BTX 1801 Phase 2a clinical study out of Perth. We are proud to be leading a promising new chapter of evidence-based research and action to address antimicrobial resistance – a pressing priority for the largest health agencies in the world.

Oxford research tackles threat of antibiotic resistance

Oxford University is opening a new research institute dedicated to tackling resistance to antibiotics.

The university says this is one of the the biggest rising threats to global health, already causing 1.5 million deaths per year worldwide.

The institute will be funded by £100m donated by the Ineos chemical company.

Click through to read the full article on BBC here.

UQ media release | Research establishes antibiotic potential for cannabis molecule

Synthetic cannabidiol, better known as CBD, has been shown for the first time to kill the bacteria responsible for gonorrhoea, meningitis and legionnaires disease.

The research collaboration between The University of Queensland and Botanix Pharmaceuticals Limited could lead to the first new class of antibiotics for resistant bacteria in 60 years.

The UQ Institute for Molecular Bioscience’s Associate Professor Mark Blaskovich said CBD – the main nonpsychoactive component of cannabis – can penetrate and kill a wide range of bacteria including Neisseria gonorrhoeae, which causes gonorrhoea.

“This is the first time CBD has been shown to kill some types of Gram-negative bacteria. These bacteria have an extra outer membrane, an additional line of defence that makes it harder for antibiotics to penetrate,” Dr Blaskovich said.

In Australia, gonorrhoea is the second most common sexually-transmitted infection and there is no longer a single reliable antibiotic to treat it because the bacteria is particularly good at developing resistance.

The study also showed that CBD was widely effective against a much larger number of Gram-positive bacteria than previously known, including antibiotic-resistant pathogens such as MRSA (methicillin-resistant Staphylococcus aureus) or ‘golden staph’.

Dr Blaskovich said cannabidiol was particularly good at breaking down biofilms—the slimy build-up of bacteria, such as dental plaque on the surface of teeth—which help bacteria such as MRSA survive antibiotic treatments.

Dr Blaskovich’s team at the Centre for Superbug Solutions mimicked a two-week patient treatment in laboratory models to see how fast the bacteria mutated to try to outwit CBD’s killing power.

“Cannabidiol showed a low tendency to cause resistance in bacteria even when we sped up potential development by increasing concentrations of the antibiotic during ‘treatment’.”

“We think that cannabidiol kills bacteria by bursting their outer cell membranes, but we don’t know yet exactly how it does that, and need to do further research.

The research team also discovered that chemical analogs – created by slightly changing CBD’s molecular structure—were also active against the bacteria.

“This is particularly exciting because there have been no new molecular classes of antibiotics for Gram-negative infections discovered and approved since the 1960s, and we can now consider designing new analogs of CBD within improved properties.”

Vince Ippolito, the President and Executive Chairman of Botanix, said the research showed vast potential for the development of effective treatments to fight the growing global threat of antibiotic resistance.

“Congratulations to Dr Blaskovich and his team for producing this significant body of research—the published data clearly establishes the potential of synthetic cannabinoids as antimicrobials,” Mr Ippolito said.

“Our Company is now primed to commercialise viable antimicrobial treatments which we hope will reach more patients in the near future. This is a major breakthrough that the world needs now.”

Dr Blaskovich said collaborating with Botanix has sped up the research, with Botanix contributing formulation expertise that has led to the discovery that how cannabidiol is delivered makes a huge difference in its effectiveness at killing bacteria.

The collaboration has enabled Botanix to progress a topical CBD formulation into clinical trials for decolonisation of MRSA before surgery.

“Those Phase 2a clinical results are expected early this year and we hope that this will pave the way forward for treatments for gonorrhoea, meningitis and legionnaires disease.

“Now we have established that cannabidiol is effective against these Gram-negative bacteria, we are looking at its mode of action, improving its activity and finding other similar molecules to open up the way for a new class of antibiotics.”

JOURNAL ARTICLE:

This research has been published in Communications Biology. See journal article HERE.

VIDEO:

Video news release and b-roll package is available HERE.

MEDIA:

H^CK Director, haley@hck.digital, +61 423 139 163 | Dr Mark Blaskovich, m.blaskovich@imb.uq.edu.au, +61 (0) 414 955380 | IMB Communications, communications@imb.uq.edu.au, +61 (0) 405 661856;

– ENDS –

Superbugs will kill 22,000 Australians annually by 2040; but these stocks are trying to stop that

Superbugs were this week labelled as “the next great health crisis of our time” and there are a few ASX stocks seeking to address it.

Superbugs are bacteria, viruses, fungi and parasites immune to conventional antibiotics and pharmaceuticals.

Yesterday, on the eve of World Antimicrobial Resistance Awareness Week, Monash University has warned superbugs could kill 22,000 Australians annually by 2040.

Read the full story on Stockhead here.

Antibiotic resistance: a matter of time

“Is this just a projection…?”  The narrator of this video asks, as she examines the possibility of a world devoid of effective antibiotics, a most precious resource. Due to “use, misuse, overuse” of antibiotics, a dire future is forecast. It is thought provoking, unnerving – but also deeply motivating to be part of global action to address antimicrobial resistance (AMR). Here at Botanix, we are committed to developing novel solutions to address AMR through our BTX 1801 pipeline. In World Antimicrobial Awareness Week (#WAAW) it’s encouraging to see this vital conversation gaining momentum too.  Watch the video on Financial Times here

Botanix Pharmaceuticals updates on meeting with FDA

AusBiotech’s BiotechDispatch featured our BTX 1801 antimicrobial program update today.

Read the full article here.

Australian Government makes strong commitment to fund the fight against AMR

The Australian Government Department of Health has this week published a summary of funding and strategy measures announced to address antimicrobial resistance (AMR) in the recent 2020-21 Federal Budget. This includes $22.5m to address the priorities identified in Australia’s National Antimicrobial Resistance Strategy – 2020 & Beyond.

Key areas, as quoted in this excerpt, include:

  1. Surveillance of Antimicrobial Use and Resistance 
    • Continuation and enhancement of the Antimicrobial Use and Resistance (AURA) Surveillance System that provides a comprehensive and integrated picture of trends of antimicrobial use and resistance in human health.
    • Assessment of Australia’s current capabilities and resource needs to develop a One Health Surveillance System. This scoping and planning phase will entail consultation with stakeholders on how to achieve the implementation of a One Health Surveillance System that integrates resistance and usage data from human health, animal health, agriculture, food and environment sectors in Australia.
    • The Department of Agriculture, Water and the Environment will conduct scoping studies to collect baseline data on antimicrobial resistance and usage in the animal health sector.
    • A pilot study will be conducted to collect baseline data on the presence of antimicrobials and resistant organisms in food. FSANZ will be responsible for this project which will commence in mid-2021.
  2. Support for the development of a Multi-Drug Resistant Organism (MRO) outbreak response capability with state and territory health authorities. This will enable a timely response to outbreaks of priority MROs detected by surveillance; building on existing capacity.  
  3. Develop a National AMR One Health Research and Development Agenda (AMR R&D Agenda). The intention is to work with stakeholders to identify gaps and priority areas for research on the prevention, detection and containment of AMR across the differing areas of research; i.e. operational and implementation, therapeutics, preventives and diagnostics. The agenda will also consider opportunities for collaboration, both nationally and internationally, and to reduce potential duplication of effort.
  4. Undertake a scoping study on pricing and reimbursement to identify new and innovative funding models to support incentivising new products that prevent, detect and contain drug-resistant infections in Australia. The study will be informed by the outcomes and lessons learned of similar studies conducted internationally.
  5. Develop a national monitoring and evaluation framework to measure Australia’s progress towards achieving the objectives of the 2020 AMR Strategy. This work is planned to commence in mid-2021.
  6. Maintain Australia’s AMR governance arrangements such as the Australian Government’s AMR advisory group; the Australian Government One Health AMR website (amr.gov.au), and meeting national and international reporting obligations.

Botanix Pharmaceuticals’ President and Executive Chairman, Vince Ippolito, commented: “Botanix Pharmaceuticals has this week announced that we have secured a clear development path from the FDA for our BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting. Our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.

“We welcome support from the Australian Federal Government as we develop our BTX 1801 antimicrobial pipeline and are committed to active and collaborative participation in the whole-of-industry response needed to address this pressing global health emergency.”

– ENDS –

Botanix Pharmaceuticals (ASX:BOT) gets U.S. FDA clearance for BTX 1801 development

Botanix Pharmaceuticals (BOT) has completed a pre-investigational new drug meeting with the U.S. Food and Drug Administration’s (FDA) Office of Infectious Diseases.

The meeting assessed the potential of initiating clinical development of the company’s BTX 1801 antimicrobial drug for preventing surgical site infections (SSIs) in the U.S.

It also enabled the company to receive feedback from the FDA on the drug development plan needed for BTX 1801 to support a Fast Track designation and New Drug Application (NDA).

Click through to read the full article on The Market Herald here.

Botanix Pharma Talks With FDA on Antibacterial Drug

The Green Fund has published a summary of Botanix Pharmaceutical’s BTX 1801 announcement today, an update on the development pathway for our BTX 1801 antimicrobial product.

Take a look at the article here.

BTX 1801 Update

Botanix (ASX:BOT) has today announced it has secured a clear development path from the FDA for its BTX 1801 synthetic cannabidiol antimicrobial product, following the successful completion of a Pre-Investigational New Drug (Pre-IND) meeting.

Our team will have more clinical data to share soon too – our BTX 1801 Phase 2a study in Perth is fully enrolled and remains on track for completion before the end of this calendar year.

Read today’s ASX release here.