Investors have cheered confirmation the US FDA granted Botanix Pharmaceuticals' (ASX:BOT) first antibacterial product (BTX 1801) approval for the prevention of post-surgical infections.
The treatment has been granted Qualified Infectious Disease Product (QIDP) status.
QIDP is designed to provide incentives for the development of novel antibacterial or antifungal products. It is only open to products that fulfil a strict set of qualifying criteria that demonstrate a product’s novelty and its potential to treat a serious or life-threatening disease.
Investors welcomed the announcement with the company's share price surging by over 50 per recent.
According to Botanix president and executive chairman Vince Ippolito, “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.
"We also look forward to continuing our work with the FDA to submit our application for ‘fast-track’ status during this quarter, with the hope of accelerating the path to market for this product. Antibiotic resistance is putting increasing pressure on our healthcare system, so our goal is to reduce infection rates and improve patient outcomes.”
The company said its data package submitted to the FDA allowed the regulator to assess both the activity of BTX 1801 and the serious or life-threatening nature of the indication it is targeting.
The company recently announced it had received ethics approval to conduct a double-blind, vehicle-controlled phase 2a study to evaluate the safety, tolerability and efficacy of two formulations of BTX 1801 to decolonise Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus from the nose of healthy adults.