Botanix Pharmaceutical’s ground-breaking research on the antimicrobial potential of cannabidiol (CBD) has been published by a leading South American academic group in BioRxiv.
The BioRxiv article confirms our discovery that synthetic CBD can also kill a select group of Gram-negative bacteria, including the bacteria responsible for the sexually transmitted disease gonorrhoea and the increasingly challenging Clostridioides difficile (C.Diff) infections.
The BioRxiv Paper follows the publication of our research in Nature Research’s peer-reviewed journal Communications Biology in January 2021, which is continuing to drive conversation around the potential of CBD to address antimicrobial resistance, globally.
Senior writer for Freethink, B.David Zarley, has published a feature article titled ‘Can CBD be the Next Superbug Slayer?’
It examines the importance Botanix’s research into the antimicrobial potential of cannabidiol and includes comments from Dr Mark Blaskovich, Director of UQ’s IMB Centre for Superbug Solutions and collaborator on our BTX 1801 antimicrobial research.
Addressing the pressing global emergency of antimicrobial resistance (AMR) is central to our work at Botanix Pharmaceuticals (ASX:BOT). Our BTX 1801 antimicrobial platform program is designed to offer novel treatments and solutions, leveraging the unique power of synthetic CBD.
This week, the ABC in Australia aired the final episode of its three-part Invisible Wars documentary series titled, “The Superbug Era”. It features Dr Mark Blaskovich, an AMR expert from the University of Queensland, who is playing a key role in the development of Botanix’s AMR platform, alongside other leading experts in this space.
The documentary is narrated by respected health commentator, Dr Norman Swan, who has been leading the national broadcaster’s coverage on the COVID-19 pandemic too. What it illuminates, in clear view, is the urgent need for novel solutions like BTX1801. Here’s an excerpt:
“When COVID-19 swept around the globe it revealed how incredibly vulnerable we are to infections for which we have no cure. Scientists are now warning of a new kind of pandemic, that could transform many treatable diseases into unstoppable killers. It’s the very real threat of antibiotic resistance. Antibiotic resistance is one of the biggest man-made threats of the modern age.”
Australian medicinal cannabis revenue is tipped to double this year amid growing confidence in the emerging sector. And WA is poised to maintain a significant hold of the market share.
While the State is recognised globally for its optimal growing conditions, local cultivators, manufacturers and researchers have also benefited from limited COVID-19 interference in their operations.
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Dr Washer said the trials were critical for the future success of the business.
“Mainstream medicine is where you want to be, and you need the right data to achieve this,” he said. “This is what makes a company attractive to big pharmaceuticals.”
Synthetic medicinal cannabis is more expensive to produce but is more accurate in eradicating THC, the compound in recreational marijuana that produces the “high” sensation.
Dr Washer said having cannabis products that were 100 per cent THC-free would be important to receive US Food and Drug Administration approval.
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Botanix Pharmaceuticals President and Executive Chairman, Vince Ippolito, presented at the ASX Small and Mid-Cap Conference today.
View the presentation here:
https://botanixpharma.com/wp-content/uploads/FB_BOT_NEW.png788940Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2021-03-16 00:00:512023-03-13 21:16:44Presentation: ASX Small and Mid-Cap Conference
Article extract | “Novartis’ acquisition represents a double-down on an antibiotics field facing an existential crisis from resistant “super bugs” that have sent most major drugmakers running for the hills — including Novartis, which dumped its antibiotic R&D program in 2018. But adding ever-greater volume to their generic antibiotics portfolio could offer Novartis some bottom-line value in the dwindling space.”
Click through to read the full article on Endpoints News.
https://botanixpharma.com/wp-content/uploads/AdobeStock_226352071-scaled.jpeg17072560Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2021-02-12 21:24:042023-03-13 21:16:44Novartis’ Sandoz splurges on a trio of GSK antibiotics, doubling down with a $500M bet on a field struggling to combat resistant microbes
Click through to read the full article on Stockhead.
https://botanixpharma.com/wp-content/uploads/Screen-Shot-2021-02-23-at-11.49.33-am.png11641518Haley Chartres/wp-content/uploads/botanix-logo.pngHaley Chartres2021-02-05 12:49:172023-03-13 21:16:44ScoPo’s powerplays: Jazz Pharma’s $9.4b deal highlights pot plays
GW Pharma $GWPH, the UK biotech that caused a sensation of sorts with the approval of the world’s first cannabinoid med, is being bought out.
Jazz Pharmaceuticals came up with the winning number, agreeing to acquire GW for a total of $7.2 billion — $6.7 billion net of cash. GW agreed to a price of $200 cash and $20 in stock for the acquisition. This is the second biotech M&A deal of the week, which will likely portend more such deals to come.’
Click through to read the full article on Endpoints News here.
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Philadelphia PA and Sydney Australia, 3 February 2021: Clinical stage synthetic cannabinoid company Botanix Pharmaceuticals Limited has today published positive data from a world first human clinical study, examining the safety, tolerability and efficacy of its BTX 1801 antimicrobial product for the eradication of Staphylococcus Aureus (Staph).
Staph, also called golden staph, is a common bacterium that lives on the skin or in the nose. In most situations it is harmless; however, if it enters the body through a cut in the skin, it can cause a range of mild to severe infections, or even death. As part of this study, Botanix was working to minimise the risk of infection by removing or decolonising bacteria from the nose – a primary site for spreading infection to other parts of the body (the nose is frequently touched, usually more than 40 times a day).
The BTX 1801 Phase 2a nasal decolonisation proof of concept study showed that two different BTX 1801 synthetic CBD formulations (ointment and gel) were safe, well tolerated and successful at eradicating Staph bacteria from the nose of healthy volunteers nasally colonised[1]with Staph.
Eradication rates as high as 76.2% were obtained at Day 7 post treatment, with eradication effects extending through to Day 28 of the study to 23.8%, despite no further treatment after Day 5. Botanix met the endpoints of its BTX 1801 Phase 2a study.
“We are very pleased to announce this top-line data that demonstrates synthetic cannabidiol (“CBD”) is a safe and effective nasal decolonisation agent. Moreover, this is the first time that synthetic CBD has been shown to have clinical utility as an antimicrobial agent in humans,” said Botanix President and Executive Chairman, Vince Ippolito.
“These results support continued development of BTX 1801 for the treatment of a variety of infections, in addition to the prevention of post-surgical infections.”
Antibiotic resistance is a significant global challenge in the context of public health, with the UN forecasting drug resistant diseases could cause 10 million deaths each year by 2050 and result in an annual economic loss of US$100 trillion if new solutions are not found.[2]
Staph and methicillin-resistant Staph (MRSA) are the leading cause of Surgical Site Infections[3] (SSIs) and approximately 80% of SSIs are caused by the patient infecting themselves from their own nose. Antibiotics used for nasal decolonisation (e.g. BactrobanTM also known as mupirocin) have seen a significant increase in the development of resistance, with some hospitals recording resistance rates as high as 95% restricting its use.
“BTX 1801’s observed upfront eradication rates and sustained eradication effect, following the treatment period, is very encouraging. Data from the BTX 1801 study represents a significant milestone and enhances the potential of better infection prevention measures in surgical settings to combat the growing global development of antibiotic resistance,” said Murdoch University’s Chair of Public Health, Professor Geoffrey Coombs.
Botanix is now actively exploring opportunities for its synthetic cannabidiol and broader cannabinoid analog assets in other secondary infections, and across different of routes of administration.
Summary of 1801 Study design and endpoints
The 1801 Study was a randomised, vehicle-controlled, double-blind, Phase 2a study conducted at a single site due to constraints associated with COVID-19. The primary objectives focused on evaluating safety and tolerability, as well as evaluating the effectiveness of two different candidate formulations of BTX 1801 (ointment or gel containing synthetic cannabidiol), compared to their respective vehicle or placebo formulations (the ointment or gel without synthetic cannabidiol). Each formulation was applied twice daily for 5 consecutive days to the anterior nares (the inner surface of the nose) of healthy participants intranasally colonised with Staph. Male and female healthy volunteers aged 18-65 were eligible to enrol in the 1801 Study.
Safety and tolerability were evaluated at prespecified timepoints during treatment (Days 1 to 5) and following treatment at Day 7 (2 days after the end of treatment), Day 12 (7 days following the end of treatment) and at Day 28 (23 days after the end of treatment). Efficacy was evaluated at Day 7, Day 12 and Day 28. No prospective calculations of statistical power were made for this exploratory study.
Summary of 1801 Study results
Results of the BTX 1801 Study show the two formulations of BTX 1801 met the Study endpoints. Firstly, BTX 1801 was safe and well tolerated, with all 66 enrolled participants successfully completing the 1801 Study with each group (ointment, gel and vehicle) consisting of 22 participants. The incidence of adverse events was low, mild in severity and occurred at similar rates across the different treatment groups with no severe events reported. Secondly, efficacy of both ointment and gel formulations at the primary endpoint of Day 12 was demonstrated.
At Day 7, one of the secondary endpoints (2 days after the end of the treatment period), Staph eradication was demonstrated in 76.2% and 68.8% of the participants in the BTX 1801 ointment and gel groups respectively, compared with 27.8% of participants in the combined vehicle groups. At Day 12 (7 days after the end of the treatment period), the primary endpoint, BTX 1801 demonstrated Staph eradication in 38.1% of participants in the ointment group and 25.0% in the gel group, compared to 16.7% for the combined vehicle groups.
Despite no treatment since Day 5 of the study, by Day 28, the other secondary endpoint, (23 days after the end of the treatment period), Staph eradication rates of both formulations of BTX 1801 only declined slightly from Day 12, to 23.8% and 18.8% for the BTX 1801 ointment and gel groups respectively, compared with 12.5% for participants in the combined vehicle groups.
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[1] Nasal colonisation or carriage of S. aureus was confirmed on 3 separate occasions over a period of up to 43 days prior to the subject receiving treatment.
[3] Decolonization to Reduce Post discharge Infection Risk among MRSA Carriers, Huan et al Feb 14 2019, N Engl J Med 2019; 380:638-650
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