Quarterly Activities Report and 4C Quarterly Cash Flow Report

Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 30 June 2021.

Key highlights from this period include:

  • Successful launch of the BTX 1702 rosacea clinical study, currently under COVID related restrictions, with sites initiated in Australia and New Zealand start up pending
  • Encouraging results achieved from the BTX 1204A pilot study of canines with atopic dermatitis, with preparation underway to commence a proof of concept canine study 
  • Preparation for the BTX 1801 Phase 2b clinical study targeting the nasal decolonisation of Staph aureus in haemodialysis patients to prevent bloodstream infections is well progressed and expected to initiate in 4Q CY2021
  • Support for Botanix’s research on the antimicrobial potential of cannabidiol published by a leading South American academic group in BioRxiv
  • Actively reviewing a number of opportunities to leverage the unique properties of the Permetrex™ technology platform to deliver new dermatology drugs

Botanix remains in a strong financial position, holding a cash balance of A$21.56m at 30 June 2021, which gives us certainty and flexibility to maintain momentum with our core programs.

Read today’s ASX release here.

Atopic Dermatitis Update + Presentation

Botanix Pharmaceuticals has today updated the market with plans for its Atopic Dermatitis (AD) clinical program. This follows important recent learnings on drug dose and formulation design of synthetic CBD in dermatitis applications, together with positive data from a new pilot study conducted in canines with AD.

Canine atopic dermatitis is clinically and immunologically similar to human AD, providing an efficient approach to inform progression of further human studies too.

A recent pilot study of Botanix’s BTX 1204A product in canines (a new higher dose formulation of synthetic CBD for atopic dermatitis, leveraging PermetrexTM), demonstrated significant reductions on average in both the Enhanced Pruritus Score (ESP) and Canine Atopic Dermatitis Extent and Severity Index (CADESI-04) scores over the 28-day treatment period.

Botanix is now advancing plans for a larger BTX 1204A proof of concept canine study in Australia, with goals to confirm and expand safety and efficacy data. Following this, the Company will pursue opportunities for partnering the product in animal health markets and progress towards a Phase 2b study for AD in humans in 1H 2022.

Read today’s ASX release and presentation here.

Investor Presentation + Conference Call

Botanix Pharmaceuticals has today released an updated investor presentation and registration details for a conference call with our investors and supporters.

participants can pre-submit questions to be answered at the end of the call, when registering through the link below.

See the updated investor presentation here.

Conference call details:

Date: Friday, 7 May 2021

Time: 11:00am AEST

Registration details:

Participants are encouraged to pre-register for the conference call. Upon registration, participants will receive a unique pin granting fast-track access to the conference call and the opportunity to submit questions to our team.

Register now.

BTX 1801 Clinical Development Update

Botanix Pharmaceuticals has today released a comprehensive update and presentation on imminent plans for the BTX 1801 antimicrobial platform program.

The next phase of development for BTX 1801 will focus on targeting the nasal decolonisation of Staph aureus in haemodialysis patients, which represents a significant market opportunity to prevent bloodstream infections in these patients.

Dialysis largely replicates the functions of the kidneys in patients with chronic kidney failure, with dialysis taking over the key functions of the kidneys (including filtering and removing waste materials from the body).  Haemodialysis patients undergoing ongoing dialysis regularly (e.g. three to five times per week), are at a high risk of bloodstream infections, due to their treatment requiring frequent use of catheters which in the first year are routinely central lines with direct access to the heart.

Our team is energised by the opportunity to develop a novel approach for removing sources of bacteria to prevent bloodstream infections in haemodialysis patients – which is desperately needed. Our prior work to examine the unique bactericidal mechanism of action of synthetic cannabidiol provides great confidence for this program too.

Read today’s ASX release and presentation here.

New AMR publication

Botanix Pharmaceutical’s ground-breaking research on the antimicrobial potential of cannabidiol (CBD) has been published by a leading South American academic group in BioRxiv.

The BioRxiv article confirms our discovery that synthetic CBD can also kill a select group of Gram-negative bacteria, including the bacteria responsible for the sexually transmitted disease gonorrhoea and the increasingly challenging Clostridioides difficile (C.Diff) infections.

The BioRxiv Paper follows the publication of our research in Nature Research’s peer-reviewed journal Communications Biology in January 2021, which is continuing to drive conversation around the potential of CBD to address antimicrobial resistance, globally.

Read today’s ASX release.

Rosacea Study Approval

Papulopustular rosacea is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face – and new therapies are in demand.

Botanix has today announced that we have received ethics approval for our BTX 1702 Phase 1b clinical study for the treatment of papulopustular rosacea, together with an expansion of the study design.

BTX 1702 is a new formulation which leverages our proprietary drug delivery system Permetrex™ with synthetic cannabidiol.

Our BTX 1702 product offers a novel potential treatment for papulopustular rosacea, with a unique mechanism of action, which could target several aspects in the pathogenesis of the disease.

We are very excited to be initiating this clinical study with leading investigators in Australia and New Zealand.

Read today’s ASX release here.

[The person featured in the above image is not an affiliate or actual patient of Botanix Pharmaceuticals Ltd.]

Progress Report for Australia’s First National AMR Strategy

The Australian Government has published the Final Progress Report for Australia’s First National Antimicrobial Resistance Strategy 2015–2019 detailing its efforts to limit the incidence of antimicrobial resistance (AMR) in Australia.

The report highlights activities implemented between 2017 and 2019 in the human and animal health, food production and the environment.

Looking ahead, the Australian Government last year announced more than $22.5 million over four years in the 2020­–21 Budget to implement an effective strategic framework for addressing AMR.

Botanix supports all efforts by the government and industry to address this pressing global health emergency. We are proud to be doing our part in the development of our BTX 1801 antimicrobial platform program too – most recently, we published world-first human data showing that our synthetic CBD-based ointment/gel formula can effectively eradicate Staphylococcus Aureus.

Download Australian Government’s Progress Report here.

World first | Human clinical study shows synthetic CBD formula eradicates Staphylococcus Aureus

Philadelphia PA and Sydney Australia, 3 February 2021: Clinical stage synthetic cannabinoid company Botanix Pharmaceuticals Limited has today published positive data from a world first human clinical study, examining the safety, tolerability and efficacy of its BTX 1801 antimicrobial product for the eradication of Staphylococcus Aureus (Staph).

Staph, also called golden staph, is a common bacterium that lives on the skin or in the nose. In most situations it is harmless; however, if it enters the body through a cut in the skin, it can cause a range of mild to severe infections, or even death. As part of this study, Botanix was working to minimise the risk of infection by removing or decolonising bacteria from the nose – a primary site for spreading infection to other parts of the body (the nose is frequently touched, usually more than 40 times a day).

The BTX 1801 Phase 2a nasal decolonisation proof of concept study showed that two different BTX 1801 synthetic CBD formulations (ointment and gel) were safe, well tolerated and successful at eradicating Staph bacteria from the nose of healthy volunteers nasally colonised[1] with Staph.

Eradication rates as high as 76.2% were obtained at Day 7 post treatment, with eradication effects extending through to Day 28 of the study to 23.8%, despite no further treatment after Day 5. Botanix met the endpoints of its BTX 1801 Phase 2a study.

“We are very pleased to announce this top-line data that demonstrates synthetic cannabidiol (“CBD”) is a safe and effective nasal decolonisation agent.  Moreover, this is the first time that synthetic CBD has been shown to have clinical utility as an antimicrobial agent in humans,” said Botanix President and Executive Chairman, Vince Ippolito.

“These results support continued development of BTX 1801 for the treatment of a variety of infections, in addition to the prevention of post-surgical infections.”

Antibiotic resistance is a significant global challenge in the context of public health, with the UN forecasting drug resistant diseases could cause 10 million deaths each year by 2050 and result in an annual economic loss of US$100 trillion if new solutions are not found.[2]     

Staph and methicillin-resistant Staph (MRSA) are the leading cause of Surgical Site Infections[3] (SSIs) and approximately 80% of SSIs are caused by the patient infecting themselves from their own nose. Antibiotics used for nasal decolonisation (e.g. BactrobanTM also known as mupirocin) have seen a significant increase in the development of resistance, with some hospitals recording resistance rates as high as 95% restricting its use.

“BTX 1801’s observed upfront eradication rates and sustained eradication effect, following the treatment period, is very encouraging.  Data from the BTX 1801 study represents a significant milestone and enhances the potential of better infection prevention measures in surgical settings to combat the growing global development of antibiotic resistance,” said Murdoch University’s Chair of Public Health, Professor Geoffrey Coombs.

Botanix is now actively exploring opportunities for its synthetic cannabidiol and broader cannabinoid analog assets in other secondary infections, and across different of routes of administration.

Summary of 1801 Study design and endpoints

The 1801 Study was a randomised, vehicle-controlled, double-blind, Phase 2a study conducted at a single site due to constraints associated with COVID-19. The primary objectives focused on evaluating safety and tolerability, as well as evaluating the effectiveness of two different candidate formulations of BTX 1801 (ointment or gel containing synthetic cannabidiol), compared to their respective vehicle or placebo formulations (the ointment or gel without synthetic cannabidiol). Each formulation was applied twice daily for 5 consecutive days to the anterior nares (the inner surface of the nose) of healthy participants intranasally colonised with Staph.  Male and female healthy volunteers aged 18-65 were eligible to enrol in the 1801 Study.

Safety and tolerability were evaluated at prespecified timepoints during treatment (Days 1 to 5) and following treatment at Day 7 (2 days after the end of treatment), Day 12 (7 days following the end of treatment) and at Day 28 (23 days after the end of treatment).  Efficacy was evaluated at Day 7, Day 12 and Day 28.  No prospective calculations of statistical power were made for this exploratory study. 

Summary of 1801 Study results

Results of the BTX 1801 Study show the two formulations of BTX 1801 met the Study endpoints. Firstly, BTX 1801 was safe and well tolerated, with all 66 enrolled participants successfully completing the 1801 Study with each group (ointment, gel and vehicle) consisting of 22 participants. The incidence of adverse events was low, mild in severity and occurred at similar rates across the different treatment groups with no severe events reported.  Secondly, efficacy of both ointment and gel formulations at the primary endpoint of Day 12 was demonstrated. 

At Day 7, one of the secondary endpoints (2 days after the end of the treatment period), Staph eradication was demonstrated in 76.2% and 68.8% of the participants in the BTX 1801 ointment and gel groups respectively, compared with 27.8% of participants in the combined vehicle groups. At Day 12 (7 days after the end of the treatment period), the primary endpoint, BTX 1801 demonstrated Staph eradication in 38.1% of participants in the ointment group and 25.0% in the gel group, compared to 16.7% for the combined vehicle groups.

Despite no treatment since Day 5 of the study, by Day 28, the other secondary endpoint, (23 days after the end of the treatment period), Staph eradication rates of both formulations of BTX 1801 only declined slightly from Day 12, to 23.8% and 18.8% for the BTX 1801 ointment and gel groups respectively, compared with 12.5% for participants in the combined vehicle groups.

– ENDS –


[1] Nasal colonisation or carriage of S. aureus was confirmed on 3 separate occasions over a period of up to 43 days prior to the subject receiving treatment.

[2] No Time to Wait: Securing the future from drug-resistant infections. Report to the Secretary-General of the United Nations (2019) available at https://www.who.int/antimicrobial-resistance/interagency-coordination-group/IACG_final_report_EN.pdf?ua=1

[3] Decolonization to Reduce Post discharge Infection Risk among MRSA Carriers, Huan et al Feb 14 2019, N Engl J Med 2019; 380:638-650

Journal article | “The antimicrobial potential of cannabidiol”

An important research project testing the targeted capabilities of our antimicrobial platform, conducted in collaboration with The University of Queensland, has been published in Communications Biology ­– a leading peer-reviewed journal by Nature Research.

The research article titled “The antimicrobial potential of cannabidiol” reveals the unique mechanism through which synthetic cannabidiol can kill the bacteria responsible for gonorrhoea, meningitis and legionnaires disease – a world first.

  • Read today’s ASX release here
  • Read the journal article here
  • Watch video produced by UQ here

All research data generated is fully-owned by Botanix and the subject of several patent applications,and it culminates significant collaborations involving respected antimicrobial researchers from around the world. The lead author is Dr Mark Blaskovich, Director of the University of Queensland’s Centre for Superbug Solutions in the Institute for Molecular Science, and it is co-authored by Botanix Directors Matt Callahan and Dr Michael Thurn.  

This is truly exciting for our antimicrobial platform. This new data demonstrates our potential to develop novel structural analogs of cannabinoids with increased antimicrobial activity providing a foundation for the development of a whole new class of antimicrobials.

The news comes as we are finalising data for our BTX 1801 Phase 2a clinical study out of Perth. We are proud to be leading a promising new chapter of evidence-based research and action to address antimicrobial resistance – a pressing priority for the largest health agencies in the world.

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.