BTX 1801 is a novel topical formulation of cannabidiol which utilises Botanix’s proprietary skin delivery technology, Permetrex, to target bacterial infections in the skin.
The QIDP status entitles BTX 1801 an extra five years of valuable FDA exclusivity, as well as eligibility for fast-track status and priority FDA review.
This is a significant milestone for Botanix as BTX 1801 is the first cannabinoid-based program to receive the designation globally and represents a strong endorsement of Botanix’s data.
Potential to prevent post-surgical infections
Botanix president and executive chairman Vince Ippolito said: “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.”
BTX 1801 clinical study update
In March 2020, Botanix confirmed it had received ethics approval to conduct a double-blind, vehicle-controlled Phase 2a study to evaluate 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.
Botanix remains confident that as soon as travel requirements within Western Australia are eased, recruitment will resume, allowing the study to potentially be completed in the third quarter of CY2020.