Botanix Pharmaceuticals (ASX:BOT) granted FDA new infectious disease designation status

• Botanix Pharmaceuticals (BOT) is granted Qualified Infectious Disease Product (QIDP) status for its investigational antibacterial product
• The new status covers usage of the treatment for the “reduction of risk of S. aureus bloodstream infections in colonised patients”
• This new designation is the first ever granted for a nasal decolonisation agent for hemodialysis patients
• Botanix has completed additional pre-clinical and animal studies to support its planned Phase 2 study, which remains on track to begin in Q2 2022
• BOT shares are up 4.61 per cent, trading at eight cents prior to market open.

Clinical dermatology company Botanix Pharmaceuticals (BOT) has been granted Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA) Office of Antimicrobial Products.

The status was given for Botanix’s novel cannabidiol antibacterial product, BTX 1801.

The new QIDP status covered usage of BTX 1801 for the “reduction of risk of S. aureus bloodstream infections in colonised patients on central venous catheter-dependent hemodialysis,” which is the lead indication for the novel synthetic cannabidiol intranasal gel.

This new designation is the first ever granted for a nasal decolonisation agent for hemodialysis patients.

“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,” President and Executive Director, Vince Ippolito said.

The FDA had previously granted QIDP designation for BTX 1801 for the prevention of post-surgical infections.

QIDP is a US FDA program designed to provide incentives for the development of novel antibacterial or antifungal products.

To be considered for this designation, candidates must fulfil a strict set of qualifying criteria that demonstrate the product’s novelty and its potential to treat a serious disease.

The major incentive afforded to a product with QIDP status is an additional five years of regulatory exclusivity, on top of the standard exclusivity that comes with FDA approval of a new drug application.

This incentive could potentially enhance the value of a successful product as it provides an extra five years of protection, during which time generics cannot enter the market.

Botanix has completed additional pre-clinical and animal studies to support its planned Phase 2 study, which remains on track to begin in Q2 2022 in Australia.

BOT shares were up 4.61 per cent, trading at eight cents prior to market open.