- 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.
- Botanix submitted a brief that outlined positive results from its pre-clinical studies, clinical development plans and a design of its current phase 2a trial
- Pleasingly, the FDA considers the proposed drug development plan and data package to be sufficient enough to initiate clinical development in the U.S.
- The FDA’s feedback also supports the submission of a New Drug Application
- Plans are now underway to begin clinical development in the U.S. once the phase 2a clinical study has been completed by the end of the year
- The BTX 1801 antimicrobial gel is being trialled to eradicate Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus bacteria from individuals that are carrying the bacteria in their nose
- Company shares are up 10.5 per cent and are trading for 10.5 cents
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).
In April this year, BTX 1801 was granted a Qualified Infectious Disease Product (QIDP) designation. A product with QIDP status gets another five years of regulatory exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug Application.
Botanix’s BTX 1801 product is a synthetic cannabidiol antimicrobial gel that is aimed at reducing post-surgical infections. Significantly, 80 per cent of these infections are caused by a nasal build-up of the Staphylococcus aureus (Staph) and Methicillin-resistant Staphylococcus aureus (MRSA) bacteria.
“We are very pleased with the excellent outcomes from the Pre-IND meeting. Botanix is now well placed to initiate clinical development of BTX 1801 in the US under an accelerated development path with the FDA,” President and Executive Chairman Vince Ippolito said.
Before the meeting with the FDA, Botanix submitted a briefing package that outlined the positive results from its pre-clinical studies, as well as its plans for clinical development.
The healthcare stock also presented the FDA with the study design for the phase 2a BTX 1801 study that’s currently underway in Australia.
Pleasingly, the FDA considers the proposed drug development plan and data package to be sufficient enough to initiate clinical development in the U.S. and support an NDA submission.
Plans are now underway to begin clinical development in the U.S. once the phase 2a BTX 1801 clinical study has been completed.
Botanix has also confirmed its phase 2a BTX 1801 antimicrobial study is fully enrolled and remains on track to be completed by the end of this year.
This study tests the ability of nasally-applied BTX 1801 to eradicate Staph and MRSA from the nose of individuals that are carrying the bacteria in their nose.
Company shares are up 10.5 per cent and are trading for 10.5 cents at 11:14 am AEDT.