Stamping the letters ‘FDA’ on a Company announcement is a surefire way to flag investors’ interest. Today it was clinical dermatology company, Botanix Pharmaceuticals’ (ASX: BOT) turn to wave the FDA flag following the granting of a new Qualified Infectious Disease Product designation for BTX 1801, an investigational antibacterial product. 

Focussed on both dermatology and antimicrobial pharmacologics, the Company utilises cannabinoids for its formulations designed to be anti-inflammatory, immune modulating and antimicrobial. Their proprietary drug delivery system, Permetrex allows for targeted delivery of drugs through the skin and is being continually developed. 

BTX 1801 is an antimicrobial gel formulation that is currently in clinical trials specifically for hemodialysis patients. The gel targets Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus (MRSA), both bacterium that can result in serious bloodstream infections in dialysis patients. Blood access infections are the most common cause of infection in hemodialysis patients with bacteria able to enter the body via catheters and needle exit sites.  In the US alone approximately 500,000 people receive dialysis treatment for end stage renal disease. Infections are a major cause of death and hospitalisation within this population with dialysis patients spending approximately 3.5 days per patient-year hospitalised for infection. Three fourths of documented infections are considered to be related to bloodstream access from the dialysis process. 

With antibiotic resistance a major problem in global healthcare, products like BTX 1801 are becoming increasingly important with applications in both human and animal health. 

The new FDA designation affords Botanix an additional 5 years of regulatory exclusivity should the product be approved. The incentive means that during the period, generic copies of the drug cannot enter the market, allowing Botanix time to establish their distribution network. The designation also means that Botanix will be eligible for priority review of their drug, cutting review time down to six months rather than the standard twelve. 

President and Executive Chairman of Botanix, Vine Ippolito said: “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 US health system more than $360 million annually.” 

BTX 1801 is currently undergoing additional preclinical studies to bolster the upcoming Phase 2 study which is set to begin at Australian sites in 2Q 2022.