Botanix Pharmaceuticals updates on meeting with FDA
AusBiotech’s BiotechDispatch featured our BTX 1801 antimicrobial program update today.
Read the full article here.
AusBiotech’s BiotechDispatch featured our BTX 1801 antimicrobial program update today.
Read the full article here.
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:
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 (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.
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.
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.