- Botanix Pharmaceuticals (BOT) is down more than 60 per cent this morning after announcing its eczema treatment failed to pass important benchmarks in its most recent trial
- The cannabidiol gel was applied to patients twice a day over 12 weeks to test its efficacy against dermatitis
- However, results have shown there was no significant difference between Botanix’s gel and a control treatment, which didn’t include the cannabidiol
- In fact, just over 12 per cent of patients who received the Botanix gel saw a reduction in symptoms, compared to 18.9 per cent of patients in the control group
- The company is now finalising a thorough review of all data and will get back to shareholders on the treatment’s future within a month
- Botanix has slumped 62.7 per cent on the market today with shares trading for 2.5 cents each
Botanix Pharmaceuticals (BOT) is down more than 60 per cent this morning after announcing its eczema treatment failed to pass important benchmarks in its most recent trial.
The Phase Two study aimed to evaluate the safety and efficacy of Botanix’s Cannabidiol gel in patients with moderate atopic dermatitis.
To put it simply, atopic dermatitis is the condition that makes the skin red and itchy, and is colloquially known as eczema.
It is long-lasting and tends to flare periodically, and it may be further triggered by asthma or hay fever.
There is currently no cure, but treatments, such as cream and tablets, and self-care measures can relieve the itching and prevent outbreaks.
The Botanix Trial
The Botanix’s study was a randomised, double-blind, vehicle-controlled study of the BTX 1204 treatment gel.
Both male and female patients were tested throughout the study and ages ranged between 12 and 70. Testing sites spanned across Australia, New Zealand and the United States.
Patients were either given an active BTX 1204 formulation twice a day or a vehicle — the formulation without BTX’s synthetic cannabidiol formulation — twice a day over 12 weeks.
The primary endpoint for the study measured the proportion of patients achieving Investigator’s Global Assessment (IGA) Success after the 12 week period.
This assessment is a five-point scale used to determine the severity of conditions in patients, particularly atopic dermatitis (AD). The review ranges from zero (completely clear) to four (severe symptoms).
In order for a new product to be successful, it must achieve at least a two-grade improvement from when the study first began.
For Botanix however, there was no statistical difference between the BTX 1204 and vehicle groups.
In fact, Just over 12 per cent of patients in the BTX 1204 group achieved IGA Success while 18.9 per cent in the vehicle group achieved IGA Success.
This outcome means the primary benchmark for the study was not met.
On top of this, treatment with BTX 1204 also didn’t meet the trial’s secondary endpoint. Nevertheless, the treatment gel provided patients with a small, but statistically non-significant improvement in the signs of AD.
Next steps
Despite this, BTX 1204 was safe and well-tolerated throughout the study. According to the clinical notes, adverse events were primarily mild or moderate in severity.
No treatment-related serious adverse events were reported, and no new or unexpected events were observed.
“We are disappointed by the results of the 1204 Study and for the many patients who are living with AD and seeking more effective treatments than those currently available,” President and Executive Chairman Vince Ippolito said.
“We plan to do a thorough review of the complete 1204 Study data set (when available) and to provide an update on the wider dermatology platform,” he added.
Botanix is now continuing to advance its first clinical trial program for BTX 1801 to decolonise staph and MRSA (methicillin-resistant staph) from the nose of healthy adults.
Botanix has slumped 62.7 per cent on the market this morning with shares trading for 2.5 cents at 11:31 am AEDT.