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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 –

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.

Antimicrobial resistance: a global health emergency

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.

The PASTEUR Act

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.

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

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.

‘Superbugs’ a far greater risk than Covid in the Pacific, scientist warns

The emergence of antimicrobial resistance (AMR), including drug-resistant bacteria, or “superbugs”, pose far greater risks to human health than Covid-19, threatening to put modern medicine “back into the dark ages”, an Australian scientist has warned, ahead of a three-year study into drug-resistant bacteria in Fiji.

“If you thought Covid was bad, you don’t want anti-microbial resistance,” Dr Paul De Barro, biosecurity research director at Australia’s national science agency, the CSIRO, told The Guardian.

Read the full article on The Guardian here.

The marketplace for new antibiotics is fundamentally broken

One of the mysteries of COVID-19 is why it kills some patients while sparing others with similar health profiles.

The answer to this will not prove singular, of course. But research published in the prestigious medical journal The Lancet found that 50% of hospitalized patients who died of COVID-19 also had secondary bacterial infections. Some patients contracted these fatal infections from the very intensive care unit (ICU) ventilators that were intended to save them.

Read the full opinion editorial – written by President and CEO of Venatorx Pharmaceuticals, Inc. – on The Inquirer here.