- Botanix Pharmaceuticals' (BOT) BTX 1801 product has been granted a Qualified Infectious Disease Product designation by the U.S. FDA
- This designation provides incentives to develop antibacterial and antifungal products, including an additional five years of regulatory exclusivity
- BTX 1801 is an antimicrobial gel aimed at reducing post-surgical infections
- 80 per cent of these infections are caused by a nasal build-up of the Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus bacteria
- Last month, Botanix announced a phase two trial but COVID-19 restrictions have delayed its completion until at least the September quarter
- After this morning's news, Botanix shares have soared 67.7 per cent in the green and are trading for 5.7 cents each
The U.S. Food and Drug Administration (FDA) has granted Botanix Pharmaceuticals (BOT) a Qualified Infectious Disease Product (QIDP) designation for BTX 1801.
QIDP is a U.S. FDA program designed to provide incentives for the development of novel antibacterial or antifungal products. It's only open to products that meet strict criteria and requires a detailed package of supporting data to the FDA, to demonstrate the product’s novelty and potential.
"Botanix is extremely proud to receive QIDP status from the FDA. This achievement is built on the back of solid pre-clinical research that demonstrates to the FDA that BTX 1801 has the potential to prevent post-surgical infections," President and Executive Chairman Vince Ippolito said.
A product with QIDP status gets an additional five years of regulatory exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug Application. This significantly increases the commercial value of a successful product.
The BTX 1801 product is an antimicrobial gel aimed at addressing the global challenge that is antibiotic resistance.
The United Nations have estimated that the ongoing development of resistance to antibiotics could lead to 10 million deaths a year by 2050 and losses of US$100 trillion if new antibiotics are not found.
Staphylococcus aureus (Staph) and Methicillin-resistant Staphylococcus aureus (MRSA) are considered the most troubling resistance-forming bacteria worldwide and are the leading cause of post-surgical infections or Surgical Site Infections (SSIs).
Interestingly, 80 per cent of SSIs are caused by the patient infecting themselves through spreading Staph and MRSA resident in their own nose. Research has shown that worldwide one in three people carry Staph or MRSA in their nose.
"Nasal decolonisation agents like BTX 1801 may represent a front-line approach towards reducing post-surgical infections, improving patient outcomes and overall reducing the economic burden on the healthcare system," Australian Society for Antimicrobials President, Chair of the Australian Group on Antimicrobial Resistance and Chair of Public Health at Murdoch University, Professor Geoffrey Coombs said.
Last month, Botanix launched a Phase two study to evaluate the safety, tolerability and efficacy of two formulations of BTX 1801 to decolonise Staph and MRSA from patients' nose.
The overall goal of this study is for every patient undergoing surgery to receive a treatment course of up to five days of BTX 1801 prior to surgery to avoid infections.
Unfortunately, the trial announcement was overshadowed by travel restrictions so the company is yet to recruit patients. The study is now expected to be completed in the September quarter.
After this morning's news, Botanix shares have soared 67.7 per cent in the green and are trading for 5.7 cents each at 10:44 am AEST.