NDA filing accelerated and trials fully enrolled

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Botanix has today announced the New Drug Approval (NDA) submission to the FDA for our recently acquired dermatology asset, Sofpironium Bromide for the treatment of excessive underarm sweating, will now be ready to file in Q3 2022.

The Company also provided an update on its pipeline clinical studies. Both the rosacea (BTX1702) Phase 1/2 clinical study and the canine dermatitis (BTX 1204A) pilot study have reached target enrolment numbers, and subjects will be completing their treatments over the coming weeks. Outcomes for these two studies are expected later in the year.

Click here to view ASX release and presentation.

New dermatology asset acquisition

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Botanix has today announced acquisition of a novel dermatology asset known as Sofpironium Bromide, which has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.

Sofpironium Bromide is the first and only new chemical entity developed for primary axillary hyperhidrosis, and this product is primed for market following successful pivotal studies conducted in late 2021.

This is a defining deal for Botanix, cementing our credentials as a global leader in the development and commercialisation of novel dermatology products. Sofpironium Bromide complements our existing dermatology pipeline and will leverage the core skills of our newly-expanded management team, with an enviable track record of successfully launching products.

Click here to view ASX release and presentation.

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 31 March 2022

Key highlights from this period include:

  • Strategic appointments to Botanix’s executive leadership team,including Dr Patty Walker as Chief Medical Officer and Mr Howie McKibbon as Chief Commercial Officer
  • Danny Sharp also joins as Non-Executive Director bringing 30+ years capital markets experience and an extensive network of institutional investors
  • Completion of pre-clinical work to support initiation of Phase 2 BTX 1801 antimicrobial study
  • Advancement of clinical programs, with the completion of recruitment for both the Phase 2 BTX 1702 rosacea study and BTX 1204 canine atopic dermatitis study, both of which are on track for 2Q 2022
  • Significant progress on broadening and maturing the Botanix pipeline with a number of new opportunities in late-stage assessment

Botanix maintains a strong cash position, with approximately $16.4 million in cash at closing of Q1 2022.

Read today’s ASX release here.

FDA grants new QIDP Designation Status for BTX 1801

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Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801.

This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central venous catheters for hemodialysis’, the lead indication for our novel intranasal gel. This represents the first such designation ever granted for a nasal decolonisation agent in this patient group.

In addition to the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA), QIDP offers an additional five years of regulatory exclusivity, as well as eligibility for NDA ‘priority review’ and ‘fast-track designation’ – both of which will be invaluable to Botanix’s antimicrobial development program.

Botanix President and Executive Chairman, Vince Ippolito commented:

“Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access.

“These life-threatening infections in this vulnerable population are estimated to cost the health system more than $360 million annually in the US.”

Click here to read today’s ASX Release

Presentation at Health Economics Conference | ISPOR 2022

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Botanix Pharmaceuticals (ASX:BOT) is pleased to share news of an upcoming poster presentation at the Professional Society for Health Economics and Outcomes Research Annual Meeting (ISPOR 2022) on 15-18 May 2022.

ISPOR is renowned for attracting leaders from the global healthcare and outcome research community for discussion and dissemination of the latest trends in healthcare.

The abstract, to be presented by lead author, Professor Tom Lodise of Albany College of Pharmacy and Health Sciences, models the annual costs associated with central venous catheter-related S. aureus bloodstream infections in hemodialysis patients.

Based on a 7.5% annual rate of infections in this vulnerable population, it is projected that attributable costs will exceed US$360 million annually. 

Dr Jamie P. Dwyer, MD, Professor of Medicine, University of Utah Clinical and Translational Sciences Institute, Co-founder of Innovative Renal Care, remarked in relation to the Abstract:

“It is widely known that S. aureus nasal carriers have a markedly higher risk of bacteremia vs non-carriers 1. There is a need for novel agents for intranasal decolonisation of S. aureus to reduce the risk of S. aureus bloodstream infections among this high risk, hemodialysis patient population.”

Click here to read today’s ASX release.

Data Presentations | ECCMID 2022

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Botanix Pharmaceuticals (ASX:BOT) is pleased to announce that data for our clinical stage antimicrobial asset, BTX 1801, will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2022) on 23–26 April 2022.

Results from our clinical program will form the basis of two abstract presentations.

The first abstract, titled ‘​​The Antimicrobial profile of BTX-1801: a new synthetic cannabidiol active against Gram-positive bacteria associated with serious infections’ will be presented by Professor Geoffrey Coombs from Murdoch University.

The second abstract, ‘The Bactericidal activity of BTX 1801: a synthetic cannabidiol with potent activity versus Staphylococcus aureus’ will be presented by Angela Kavanagh from the Centre for Superbug Solutions at The University of Queensland.

Botanix President and Executive Chairman, Vince Ippolito, said:

“The data to be presented at the upcoming ECCMID 2022 conference suggests the significant potential of BTX 1801 to prevent S. aureus bloodstream infections associated with considerable morbidity, mortality, and cost in haemodialysis patients who use Central Venous Catheters (CVC).”

Click here to read today’s ASX release.

Botanix further expands executive team

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Botanix has today welcomed two highly experienced US-based dermatology executives to the team:

  • Chief Medical Adviser, Dr Patricia Walker 
  • Chief Commercial Officer, Mr Howie McKibbon

Dr Walker is a board-certified dermatologist specialising in medical and aesthetic dermatology. She is an industry expert and has served in various leadership roles, including President and head of R&D for Brickell Biotech; Chief Medical Officer for Kythera Biopharmaceuticals, Inc.; Executive Vice President and Chief Scientific Officer for Allergan Medical Aesthetics; and Vice President and Dermatology Therapeutic Area Head at Allergan. 

Howie has more than 20 years of leadership experience in the pharmaceutical industry, including working directly as part of my team as Senior-Vice President, Sales and Marketing at Anacor Pharmaceuticals; Senior Vice-President, Worldwide Commercial Operations at Dermavant Science; and  Vice-President, Dermatology and Immunology at Medicis Pharmaceuticals. Howie has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion. 

These new executives contribute valuable dermatology and commercial leadership credentials to our team, as Botanix prepares to move from clinical development towards focused commercialisation of our product portfolio.

Click here to read today’s ASX release.

Danny Sharp appointed Non-Executive Director

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Botanix has today announced the appointment of a new Australian-based Non-Executive Director to the Board, Danny Sharp.

Danny is a highly respected investment banker with more than 30 years’ experience and strong networks within global capital markets, institutional investment and private wealth too. Healthcare and technology are his speciality areas of expertise.

Most recently, Danny was Corporate Finance Executive Director of Canaccord Genuity, and he has previously spearheaded the Corporate Finance departments at both Shaw and Partners and Lodge Partners. 

Click here to read today’s ASX release.

Quarterly Activities Report and 4C

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Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2021.

Key highlights from this period include:

  • Botanix’s canine atopic dermatitis program, BTX 1204A, is progressing well. Following the launch in September last year, recruitment has been strong, and the study is on track to finish enrolment this quarter.
  • BTX 1702 Phase 1b/2a Rosacea Study continues to progress well with enrolment on target to be completed mid-year. This study is of strategic importance for the Company, as the results will provide key safety and efficacy data, as well as other valuable insights for our wider clinical development program.
  • Pre-clinical work to support the initiation of a Phase 2 human study for its BTX 1801 antimicrobial program is complete with the clinical study planned to initiate at the end of this quarter.

Botanix’s balance sheet remains strong, with $16.8 million in cash at closing of 4Q 2021 with R&D tax return to come this quarter.

Read today’s ASX release here.

Investor Roadshow Presentation

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Botanix has today released an updated corporate presentation to the ASX, to support a non-deal investor roadshow underway this week.

The latest developments in our antimicrobial resistance (AMR) and dermatology R&D programs, include:

  • Progress with our BTX1801 antimicrobial program and plans for Phase 2 clinical studies in early 2022
  • Advancement of our BTX1702 clinical trial for the treatment of rosacea
  • Acceleration of our canine BTX1204A dermatitis study

Click here to view the presentation.