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Corporate Update Presentation

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Botanix Pharmaceuticals has released a corporate presentation to the ASX this morning, which is being shared with investors as part of meetings over the course of the next week.

Key highlights include:

  • Successful launch of BTX 1702 rosacea clinical study, with recruitment well underway
  • Design of the BTX 1204A pilot study of canines with atopic dermatitis, which is about to commence 
  • Preparation for the BTX 1801 Phase 2b clinical study targeting the nasal decolonisation of Staph aureus in haemodialysis patients
  • Reviewing new opportunities to leverage the unique properties of our Permetrex™ technology platform in dermatology 

Our Company remains in a strong financial position, holding a cash balance of A$21.56m at 30 June 2021, and is progressing strategically forward to deliver these core programs.

Read Presentation and ASX Release here.

Research Report by Euroz Hartleys

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Botanix (ASX:BOT) is pleased to advise that leading adviser Euroz Hartleys has initiated coverage on Botanix as we lead into an exciting 12 months of clinical studies and corporate activities.

This report reinforces our belief that Botanix has assembled the right people, technology and research strategies to advance our assets, and to deliver positive results for our shareholders and the patients we exist to serve.

Read the full report.

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

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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

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“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. 

Australian Government makes strong commitment to fund the fight against AMR

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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.”

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

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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.

BTX 1801 Update

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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.

Quarterly Report

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Botanix Pharmaceuticals has released its latest Quarterly Report – a period which has delivered a series of progress milestones.

In our antimicrobial program, we commenced a Phase 2a clinical trial for BTX 1801 to study the use of synthetic cannabidiol in the prevention of surgical site infections. We also shared new data from an ex vivo efficacy study, which further validates the mechanism of action of our antimicrobial platform.

In our dermatology program, we successfully completed an End of phase 2 meeting with the FDA for our BTX 1503 acne product. We’re also looking forward to commencing recruitment for our BTX 1702 program for the treatment of Rosacea, when COVID-19 travel restrictions ease.

Read the full report here.

Australia’s first Antimicrobial Resistance Network forms to combat global health threat

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Botanix welcomes, wholeheartedly, today’s news from MTPConnect announcing the formation of an Australian-first network to address the impact of antimicrobial resistance (AMR) on human health.

The Australian Antimicrobial Resistance network – AAMRNet – was launched in response to urgent recommendations in a new report by MTPConnect, ‘Fighting Superbugs: A Report on the Inaugural Meeting of Australia’s Antimicrobial Resistance Stakeholders’.

Professor Geoffrey Coombs, member of the AAMRNet Steering Committee and President of the Australian Society for Antimicrobials, is involved in our BTX 1801 clinical study in Perth. We are fortunate to be collaborating with leaders in this sector to examine the full potential of our platform AMR product.

Addressing the impact of AMR is a foremost priority for our business. We look forward to supporting this network and contributing valuable clinical data to our combined efforts to address what is one of the most significant, pressing threats to global health.

Read more from MTPConnect here.

Drug study will use synthetic cannabidiol to fight antimicrobial resistance

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Addressing antimicrobial resistance is a pressing priority for the largest health agencies in the world, so Botanix is optimistic in its efforts to proactively navigate these challenges.

Recruitment has today commenced in Perth for a Phase 2a study of Botanix’s antimicrobial platform product BTX 1801 to evaluate its safety, tolerability and efficacy for the prevention of surgical site infections.

The Phase 2a clinical study has been designed to evaluate two formulations of BTX 1801 to decolonise Staphylococcus aureus (Staph) and methicillin-resistant Staphylococcus aureus (MRSA or ‘Golden Staph’) from the nose of healthy adults. Nasal carriage of Staph and/or MRSA greatly increases the risks of serious and sometimes life-threatening infections following surgery, as patients essentially infect themselves. 

Botanix is working with a team of specialist clinical investigators, led by Murdoch University’s Chair of Public Health and Chair of the Australia Group on Antimicrobial Resistance, Professor Geoffrey Coombs. 

Read the Murdoch University news article here.