The Botanix Pharmaceuticals Ltd (ASX: BOT) share price is surging higher today after a positive announcement.
In the minutes after market open, shares in the synthetic cannabinoid company jumped as high as 11.5 cents. The Botanix share price has retreated slightly during the day to 11 cents, up 15.79% at the time of writing.
What does Botanix do?
Botanix is a synthetic cannabinoid pharmaceutical company that focuses on dermatology and antimicrobial products.
Based in Perth, Australia and in Philadelphia, United States, the company has a pipeline of product candidates undergoing clinical trials. Botanix aims to address patients who have serious skin diseases, as well as prevent surgical site infections.
Pre-IND meeting completed
Botanix advised that it successfully completed a pre-Investigational New Drug (IND) meeting. The appointment took place with the United States Food and Drug Administration's (FDA) office of Infectious Diseases for its lead antimicrobial program, BTX 1801.
The pre-IND meeting provided Botanix an opportunity to seek advice and clarification from the FDA 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. In April, Botanix was granted Qualified Infectious Disease Product status, giving the company priority FDA review and faster two-way communication.
Before the meeting had occurred, Botanix submitted data outlining the successful results from its pre-clinical studies. In addition, the company also provided the FDA with future manufacturing and clinical development plans.
The FDA stated that the data and development package was sufficient to begin clinical trials in the US. Should the study become a success, an IND application will follow.
Currently, Botanix is in a Phase 2a trial for BTX1801 in Western Australia. The study is fully enrolled and expected to be finished at the end of the calendar year. Data from the antimicrobial trial will be available shortly after completion, and provided to investors in due course.
What did management say?
Botanix president and executive chair Vince Ippolito commented on the achievement, saying:
We are very pleased with the excellent outcomes from the Pre-IND meeting. Botanix is now well placed to initiate clinical development of BTX 1801 in the US under an accelerated development path with the FDA.
About the Botanix share price
The Botanix share price has been on a wild run of late, jumping from 4.9 cents at the start of September to 10.5 cents today. This represents a gain of more than 114% in the space of less than 3 months.
Reaching a 52-week high in October of 12.5 cents, Botanix is just shy of regaining that feat again.
The company is still considered as a small-cap share with a market capitalisation of $102.1 million.
