Botanix Pharma achieves statistically significant results with its acne drug BTX 1503, achieving the end-goal of reducing lesions.
Today, Botanix Pharmaceuticals Limited (ASX:BOT) released an investor presentation that updated investors on the company's progress on its key clinical programs.
A primary focus of the presentation was the additional analysis of the Phase 2 BTX 1503 acne study, which found that the secondary endpoint of lesion reduction was statistically significant over the vehicle. (p=0.033)
The endpoint of reducing acne-related lesions that are both inflammatory and non-inflammatory is one that dermatologists use to see how effective current acne medication is. The results were achieved using a 5% formula of BTX 1503 once daily.
The company attributes the success of its formulas to several factors, starting with synthetic CBD's ability to modulate the immune response, reduce inflammation and produce antimicrobial effects. Additionally, BOT's cannabinoid formulas utilize its Permetrex technology, which allows topicals to enter the skin without using preservatives or alcohol-based derivatives.
When combining oral and topical prescriptions for acne medications in the US, there's a total of 20 million prescriptions, amounting to $400 million per year according to Consumer Reports.
The Phase 2 study for BTX 1503 was carried out in both the US and Australia, lasting 12 weeks and involving 368 subjects, who were split into four groups of 92 subjects.
One group was taking a high dose twice daily, the second group was taking the high-dose once daily, the third group took a low dose daily, and the fourth and final group took only the vehicle.
The Australian Phase 2 study revealed that a once-daily high dose (5%) treatment of BTX 1503 was the most effective, and the results were a welcomed change from the previously announced, bizarre US results, which saw the vehicle alone providing 2-4 times the response seen in the recent Australian results.
The company reports that BTX 1503 has an "exceptional" safety profile, and that over half of the patients of the trial were under age 18, who typically have been the least respondent to acne treatment.
The company will be moving ahead with its acne drug, in addition to the rest of its portfolio of drug candidates.
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