Cannabinoid company Botanix Pharmaceuticals (ASX: BOT) has found its way into the fast lane towards FDA approval for their antimicrobial product BTX 1801, developed to prevent post-surgical infections, having secured Qualified Infectious Disease Product (QIPD) designation which will expedite their FDA review process.
The designation of QIPD status for BTC 1801 is the first for a cannabinoid-based program with Botanix ready to recruit for Phase 2a clinical trials as soon as COVID-19 travel restrictions are eased.
“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,” said Botanix Chairman, Vince Ippolito.
“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.”
Having used its existing data, Botanix was able to meet a strict set of qualifying criteria to demonstrate BTC 1801’s potential to treat a serious or life-threatening disease. Beyond the current coronavirus pandemic drawing pharmaceutical attention to antimicrobial products, antibiotic resistance has been flagged by medical professionals for many years as a significant public health challenge of the future.
Staph and MRSA are recognised as the most troublesome resistance forming bacteria worldwide and are the leading cause of post-surgical infections, something Botanix will tackle.
Also included in their QPID designation, Botanix will be entitled to an extra five years of FDA exclusivity for BTX 1801 which has a significant addressable market where there are more than 300 million surgical procedures carried out around the world each year.
Upon news of their designation to fast-track FDA approvals, shares in BOT rose to a high of $0.065 in morning trade, a rise of 91% on their previous close of $0.034.
Alfred Chan is a Business Reporter at The Sentiment specialising in ASX-listed small cap companies, a bloodstock enthusiast and former equities analyst.
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