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- Synthetic cannabinoid company Botanix Pharmaceuticals (BOT) has completed phase two of its BTX 1801 clinical studies in Western Australia
- Findings on the promising antimicrobe are expected in early 2021 with data collection well underway
- The clinical study tested two different formulations of the antimicrobe and its ability to eradicate antibacterial resistant surgical site infections from the nasal cavities of healthy participants
- Results from the study are hoped to support an Investigational New Drug Filing (IND) filing and rapid progression into phase three studies for the Food and Drug Administration (FDA) registration
- In April this year, BTX 1801 was granted Qualified Infectious Disease Product (QIDP) status from the FDA for the prevention of post-surgical infections
- BOT shares are up 4 per cent following the announcement, trading at 13.5 cents each
Synthetic cannabinoid company Botanix Pharmaceuticals (BOT) has completed phase two of its BTX 1801 clinical studies in Western Australia.
Findings on the promising antimicrobe are expected in early 2021 with data collection well underway.
The results of which are hoped to support the submission of an Investigational New Drug Filing and advance the progression to phase three studies required for Food and Drug Administration (FDA) registration.
More specifically, the clinical study tested two different formulations of the antimicrobe and its ability to eradicate Staphylococcus (staph) aureus infection and methicillin-resistant Staphylococcus aureus (MRSA) from the nasal cavities of healthy participants.
Botanix writes that 80 per cent of all post-surgical infections are caused by the patient infecting themselves through spreading Staph and MRSA present in their own nasal cavity.
This announcement forms the latest instalment in the antimicrobe’s timeline.
BTX 1801 was granted Qualified Infectious Disease Product (QIDP) status from the FDA in April this year and has most recently conducted a Pre-Investigational New Drug (Pre-IND) meeting for its BTX 1801 synthetic CBD antimicrobial product.
Botanix President and Executive Chairman, Vince Ippolito thanked study participants and looks forward to updating the market once data from the study has been finalised.
“There has not been a new class of antibiotic for the treatment of gram-positive bacteria in more than 30 years and serious Staph and MRSA infections have become very difficult to treat,” he explained.
“The company has worked diligently to complete the BTX 1801 phase 2a study despite the significant disruption caused by the COVID-19 pandemic by
conducting the study in Western Australia.”
BOT shares are up 4 per cent following the announcement, trading at 13.5 cents each at 8:07 am AEDT.
