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.”

– ENDS –

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.

Botanix Pharma Talks With FDA on Antibacterial Drug

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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

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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.

Antimicrobial resistance: a global health emergency

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Botanix has appeared in a must-read feature about antimicrobial resistance (AMR) in the latest edition of AusBiotech’s Australasian Biotechnology Journal.

It is titled, “Antimicrobial resistance: a global health emergency”.

A quote from WHO Director-General Dr Tedros Adhanom Ghebreyesus, featured in the story, points to the importance of the work we are doing in this space:

“AMR is a slow tsunami that threatens to undo a century of medical progress. A record number of countries are now monitoring and reporting on antibiotic resistance to WHO”.

Read the full story on pages 52-54 here.

Why I think these small cap ASX shares will perform in 2021

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The Motley Fool’s Aaron Teboneras featured Botanix Pharmaceuticals as a top stock pick in an article today.

“At the time of writing, the Botanix share price is trading at 10 cents, up 7.5% for the day. With a market capitalisation of $97 million, if the company can perform to market expectations, its share price will soar.”

Read the full article here.

The PASTEUR Act

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Two US lawmakers have introduced a bipartisan bill to create a new payment model to encourage drug developers to develop new classes of antibiotics.

It’s called the PASTEUR Act, which will facilitate upfront payments to companies in exchange for unlimited access to their antibiotics. In turn, drug makers can recover their costs and turn a profit, before selling large volumes of product. 

Relevant extracts include:

  • An antimicrobial drug developer can apply to receive a ‘critical need antimicrobial’ designation
  • Contracts will range from $750 million to $3 billion and will be paid out over a period of up to 10 years or through the length of patent exclusivity

Botanix Pharmaceuticals wholeheartedly welcomes this news. As we enter a critical period of R&D for our BTX 1801 antimicrobial resistance (AMR) platform, this is a significant endorsement of the immediate need for novel antibiotics and further evidence of the world’s most powerful pharmaceutical influencers prioritising expedited and significant expenditure in this space.

Read a summary of the bill here.

This new antimicrobial resistance network could boost Recce, Botanix and Next Science

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Botanix Pharmaceuticals Executive Director, Matt Callahan, spoke with Stockhead about the global threat of antimicrobial resistance yesterday:

“The alarm bells have been going off the last five years (on antimicrobial resistance), but no one’s really believed that the global economy could be stopped and millions and millions of deaths could be caused by some kind of pathogen – but of course I think we all believe that now, sadly,” he said.

Read the full article 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.