The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is trading higher today on news the company has completed its phase 2a clinical study for BTX 1801.
In mid-morning trade, the Botanix share price was up 8% to 13.5 cents. It has since retreated to 13 cents, up 4% at the time of writing. In comparison, the All Ordinaries Index (ASX: XAO) is currently up 0.4% to 6,915 points.
Botanix is a synthetic cannabinoid pharmaceutical company that focuses on dermatology and antimicrobial products. The BTX 1801 gel prevents surgical site infections by killing bacteria during surgery incisions. Botanix aims to combat the growing global antibiotic resistance that affects millions each year.
What's driving the Botanix share price higher?
The Botanix share price is on the move after the company advised that all 60 of its participants have completed the BTX 1801 phase 2a clinical study. The purpose of the trial was to evaluate the safety, tolerability and efficiency of BTX 1801 for the prevention of surgical site infections.
As the data is being collated, the company plans to update the market with its report in early 2021.
Furthermore, the results will be used to support a fast-track designation and new drug application with the United States Food and Drug Administration (FDA).
Timeline of BTX 1801
In April this year, Botanix received a major boost from the FDA's Office of Antimicrobial Products. BTX 1801 was awarded with a qualified infectious disease product status. This allows a five-year regulatory exclusivity, meaning generic products cannot enter the market. Furthermore, the company was given priority FDA review and faster two-way communication.
Last month, Botanix completed a pre-investigational new drug (IND) meeting with the FDA. The productive appointment gave the company an opportunity to seek advice and clarification on what's required to initiate clinical studies.
In addition, the company received feedback on the drug development plan for BTX 1801 to fast-track its FDA process.
Management commentary
Commenting on the BTX 1801 progress, Botanix president and executive chair Vince Ippolito said:
There has not been a new class of antibiotic for the treatment of gram-positive bacteria in more than 30 years and serious staph and MRSA infections have become very difficult to treat.
The company has worked diligently to complete the BTX 1801 Phase 2a study despite the significant disruption caused by the COVID-19 pandemic by conducting the study in Western Australia.
About the Botanix share price
The Botanix share price has been surging higher since COVID-19 stormed the world earlier this year. From a low of 2.3 cents in March, the Botanix share price reached a 52-week high of 15 cents 2 weeks ago.
