Dermatology Update

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Botanix Pharmaceuticals (ASX:BOT) has today provided an update on its dermatology program, focusing on the BTX 1204A canine study for atopic dermatitis and BTX 1702 rosacea study.

The BTX 1204A canine study for atopic dermatitis has now been launched. This will enrol 45 canines and evaluate two formulations of BTX 1204A. Positive data from a pilot study in May has already demonstrated that a new higher dose of synthetic CBD, in a novel Permetrex™ formulation, reduces severity of atopic dermatitis over 28 days – providing strong foundations to extend this program into both animal and human health.

The BTX 1702 rosacea study is also gaining momentum. Despite COVID-19 restrictions, recruitment is progressing according to plan in Australia and New Zealand – with a goal to enrol 120 patients to investigate the safety and tolerability of two different concentrations of BTX1702.

Click here to read today’s ASX Release

Botanix Expands Management Team

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Botanix (ASX:BOT) has expanded its management team with the appointment of new Senior Vice President of Pharmaceutical Development, Dr Jack Hoblitzell.

Dr Hoblitzell brings over 30 years of extensive experience in leading world-class technical operations, manufacturing and supply chain management. He has held senior leadership roles in the US with companies including Pfizer, King Pharmaceuticals, Ivax Pharmaceuticals and Teva Pharmaceuticals, where he led numerous successful new product launches and regulatory submissions.

Vince Ippolito, President and Executive Chairman, commented:

“We are pleased to welcome Jack to the Botanix team. His depth of experience and success in leading successful new product launches and regulatory submissions will be invaluable as we continue to focus on our clinical programs as they move into last stage studies and commercial manufacturing, as well as our increasing work with the Permetrex™ platform.”

Click here to read today’s ASX release.

Corporate Update Presentation

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Botanix Pharmaceuticals has released a corporate presentation to the ASX this morning, which is being shared with investors as part of meetings over the course of the next week.

Key highlights include:

  • Successful launch of BTX 1702 rosacea clinical study, with recruitment well underway
  • Design of the BTX 1204A pilot study of canines with atopic dermatitis, which is about to commence 
  • Preparation for the BTX 1801 Phase 2b clinical study targeting the nasal decolonisation of Staph aureus in haemodialysis patients
  • Reviewing new opportunities to leverage the unique properties of our Permetrex™ technology platform in dermatology 

Our Company remains in a strong financial position, holding a cash balance of A$21.56m at 30 June 2021, and is progressing strategically forward to deliver these core programs.

Read Presentation and ASX Release here.

Botanix FY21 Annual Report

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Botanix (ASX:BOT) has today published its its Annual Report for the 2020-2021 Financial Year (FY21)

Key highlights from this financial year include:

  • Successful completion of BTX 1801 antimicrobial  Phase 2a  clinical  study, showing two different BTX 1801 formulations were safe, well tolerated and successful at eradicating Staphylococcus Aureus.
  • BTX 1702 rosacea clinical study was successfully launched in Australia & New Zealand and is actively recruiting.
  • Positive results achieved from the BTX 1204A pilot study of canines with atopic dermatitis, with a larger proof of concept canine study ready to kick off.
  • Expansion of the Management team  in  the  US  to  drive  clinical  and  commercial activities across the antimicrobial and dermatology programs.
  • Preparation for the BTX 1801 Phase 2b clinical study targeting the nasal decolonisation of Staph aureus in haemodialysis patients is progressing well and is positioned to validate synthetic CBD as a novel new antimicrobial.

Click here to read the report.

Quarterly Activities Report and 4C Quarterly Cash Flow Report

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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

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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

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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

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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

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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

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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.]