Botanix wins US FDA tick ahead of Oz trials

Botanix Pharmaceuticals (ASX:BOT) has seen its investigational BTX 1801 product given QIDP status by the US FDA in a move that means nobody can make a competitor generic product for the next 5 years. 

The FDA has awarded Botanix QIDP for its BTX 1801 product before, but, in post-surgical applications. This morning’s news means the status has been given to Botanix for use of the product in patients on dialysis. 

The intranasal gel, Botanix believes, can be used to treat blood infections in patients with kidney failure who may encounter bloodstream complications due to reliance on a dialysis machine, which purifies the blood outside the body mechanically. 

Botanix charts compared to the ASX 200 Health Index over last 6 months

FDA fast-track approval status locked in 

Should BTX 1801 be a success for patients with targeted blood infections receiving dialysis treatments, the FDA will award those patients “priority review” for assessment by the North American medical regulator. 

The normal assessment process lasts for twelve months, but companies with the privilege of priority review access are awarded six month assessment timeframes. 

Botanix says fast track designations also award the company a heightened line of communication with FDA representatives during the greenlight pipeline, which the company sees as a chance to allow for greater guidance to be included during its development program. 

Australian trials on the immediate horizon 

Following the completion of pre-clinical and animal studies, Botanix is moving ahead with its Phase 2 Study of its BTX 1801 product in Australia. 

The company expects those trials to commence in Q2 of 2022, which we already one-third of the way through, meaning the Australian trials will commence at some point before June. 

Botanix Pharmaceuticals develops medical products incorporation cannabinoid compounds.

Botanix up over 5% in late morning trade