- Cannabinoid pharmaceutical player Botanix Pharmaceuticals has completed a pre-IND meeting with the FDA’s Office of Infectious Diseases for clinical development of BTX 1801.
- The US regulatory body stated that the proposed plan and data package is adequate to commence clinical development of the antibiotic in the US.
- The Company confirms that Phase 2a antimicrobial clinical trial of BTX 1801 is on track for completion in 4Q CY2020.
Perth-headquartered Botanix Pharmaceuticals Limited (ASX:BOT) today announced that it pre-investigational new drug (pre-IND meeting with the US FDA was a success. The favourable outcome of the meeting clears the path for the development of its synthetic cannabidiol antimicrobial product BTX 1801.
The share price of Botanix climbed by 15.789% to A$0.110, following the announcement. The Company has a market capitalisation of A$92.40 million.
Let us look at the details of the meeting:
Botanix Pharmaceuticals gets FDA clearance for development of BTX 1801
Clinical-stage synthetic cannabinoid player Botanix Pharmaceuticals Limited is engaged in the development of medicines backed by well-controlled clinical trials. The Company is developing a pipeline of candidates leveraging cannabinoid’s antimicrobial properties.
On 11 November 2020, Botanix Pharmaceuticals Limited successfully completed a Pre-IND meeting with the US FDA’s Office of Infectious Diseases for BTX 1801.
The pre-IND meeting provided Botanix with an opportunity to get advice from the FDA on the development plan as well as data package essential to commence clinical trials for BTX 1801 in the US.
With the FDA clearance, the Company will receive feedback from the FDA on the drug development plan required for BTX 1801 to support a Fast Track designation and NDA in light of its existing QIDP designation.
Moreover, Botanix also presented an update and the study design of the Phase 2a BTX 1801 clinical study to the FDA. The clinical trials are underway in Western Australia.
The FDA urged Botanix to apply for a Fast Track designation for BTX 1801 after submission of an IND application.
Botanix notified that plans are in progress to start clinical development in the US under an IND after completion of the ongoing Phase 2a BTX 1801 clinical trial.
The Company also confirms that BTX 1801’s Phase 2a antimicrobial clinical trial is now fully-enrolled and on track for completion in the fourth quarter of CY 2020. Data from the trial is expected shortly after the study completes.
BTX 1801 Clinical Development
BTX began recruitment for BTX 1801’s Phase 2a study in August. The study was designed to assess the efficacy, safety, and tolerability of the antibiotic for the prevention of surgical site infections.
In September, the Company data from an ex vivo efficacy study showing that BTX 1801 eliminated methicillin-resistant Staphylococcus aureus (MRSA) from the infected human skin explants after a day of treatment. Another study was conducted, which supported the findings of the first study.
Botanix President and Executive Chairman, Vince Ippolito commented-