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.
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.
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 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.
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:
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.
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.
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.
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.
Experts have warned that the COVID-19 pandemic might just be one in a series of increasingly frequent viral outbreaks, as the human species enters what they describe as “a pandemic era”.
Anthony Fauci, leading US immunologist and director of the National Institute of Allergy and Infectious Diseases (NIAID), and David Morens, a medical epidemiologist at NIAID, predict that widespread outbreaks of diseases and epidemics will only accelerate over the coming years as populations grow, societies expand and deforestation increases.
Read the full article on Vice here.
‘After colonising the skin explants with methicillin-resistant staphylococcus aureus (MRSA), the “Human Skin Study” found that BTX 1801 successfully eliminated the so-called superbug within 24 hours.’
Read the full article on Stockhead here.
