Products & Pipeline
Our lead dermatology product Sofdra™ (sofpironium) topical gel, 12.45% is an FDA-approved treatment. Beyond Sofdra, our mature product pipeline features a range of dermatology and antimicrobial products.
Introducing Sofdra: Now Approved in the US
Sofdra has received FDA approval. Sofpironium has already been approved in Japan and launched by our partner Kaken Pharmaceutical Co., Ltd. (Ecclock® Sofpironium Bromide 5%).
Dermatology Pipeline
Our clinical studies to date have proven the unique mechanism of action which drives synthetic cannabidiol (CBD) to produce anti-inflammatory and antimicrobial effects. We are now working hard to develop new pharmaceutical products in dermatology, targeting underserved market segments that are primed for new solutions. Our product pipeline targets the following skin diseases:
BTX 1503 for Acne
A transdermal gel formulation for the treatment of serious acne in adults and teenagers. Acne is a skin condition that manifests in pimples, lumps, and cysts and is the leading cause of visits to dermatologists and psychological difficulties in adolescents. It is the most common skin disorder in the US affecting 40-50 million Americans and it is estimated the market will grow to a value of US$5.9 billion by 2025. Acne has multiple pathogenetic pathways including sebum overproduction, unwanted sebocyte proliferation, inflammation, and bacterial infection. Synthetic CBD has been shown in scientific studies to normalise excessive lipid synthesis of human sebocytes, suppress cell proliferation, and provide an anti-inflammatory effect to potentially reduce bacterial infection. In turn, this could help to reduce the occurrence or severity of serious acne.
BTX 1702 for Rosacea
A new product opportunity for the treatment of papulopustular rosacea. Rosacea is a chronic inflammatory skin disease that often begins with a tendency to blush or flush more easily than other people, but can progress into many subtypes, including papulopustular rosacea. Papulopustular rosacea is a highly visible and distressing chronic inflammatory skin disease characterised by intensely inflamed skin and acne-like breakouts across the face, which affects more than 16 million Americans. The BTX 1702 program is being expedited based on mechanistic data generated by Botanix that shows synthetic CBD exerts powerful anti-inflammatory and antimicrobial actions in skin—two key activities that are critical for successfully treating rosacea.
BTX 1204A for Atopic Dermatitis
Botanix is pleased to be progressing a BTX 1204A canine study in Australia and New Zealand for atopic dermatitis. This will enrol 45 canines and evaluate two formulations of BTX 1204A. Positive data from the pilot study in May has already demonstrated that a new higher dose of synthetic CBD, in a novel Permetrex™ formulation, reduces severity of atopic dermatitis over 28 days—providing strong foundations to extend this program into both animal and human health.
Antimicrobial Pipeline
BTX 1801 for Hemodialysis Patients
An antimicrobial gel focused on targeting Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus (MRSA). Botanix Pharmaceutical’s research to date shows synthetic cannabidiol rapidly kills MRSA within 10 minutes of exposure by a novel mechanism of action and without allowing resistance to develop. BTX 1801 is initially focused on preventing bloodstream infections in patients undergoing hemodialysis treatment, by removing or ‘decolonising’ bacteria in the patient’s nose. These patients have at least one such infection each year, and most die from an infection within three years of starting hemodialysis. Botanix plans to test the capabilities of synthetic cannabinoid for fighting antibiotic resistance more broadly—a major global issue in healthcare—and to develop a novel platform product for multiple human and animal health applications.
