Clinical Trials

Clinical Trials

Clinical Trials

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Clinical trials in humans are used to assess potential treatments that have had some effect against disease in the lab, or in animal experiments.

The objective of a clinical trial, is to find out if a treatment is safe and if it is effective.

Botanix is rapidly progressing a number of products through the clinic and at any time may have one or more clinical studies open for enrolment to prospective patients.

This page contains links to information about Botanix’s current clinical trials and where to find more information on each trial for interested patients.

Lead product: BTX 1503 (Moderate to Severe Acne)

  • Botanix is developing BTX 1503 as a novel treatment for moderate to severe acne
  • Botanix successfully completed a Phase 1b study of BTX 1503 during 1Q CY2018
  • The study achieved all the BTX 1503 program goals, indicating that it has an excellent safety profile, is very effective at reducing the number of inflammatory and non-inflammatory acne lesions, and provided an improvement in patient rated satisfaction
  • BTX 1503’s (on average) ~47% reduction in inflammatory lesions was greater than any other FDA-approved topical acne product for which data is available after four weeks of treatment
  • The US FDA has approved commencement of Phase 2 clinical trial which will be conducted in the US and Australia
  • The Phase 2 clinical trial is fully funded following the Company’s successful capital raising in February 2018
  • The trial, which is on track to commence in June 2018, will enroll approximately 360 patients and take about 12 months to complete
  • Patients enrolling in the study will be treated with one of two high doses, a low dose or placebo (or vehicle) and have similar endpoints as the recently completed Phase 1b study
  • The study is on track to commence in June 2018 and will take approximately 12 months to complete

Acne Examination

BTX 1204 (Atopic Dermatitis)

  • Botanix is developing BTX 1204 as a new treatment for mild to moderate atopic dermatitis (eczema)
  • Botanix successfully completed enrolment of Phase 1b of its BTX 1204 patient study in April 2018
  • The Phase 1b study is a 4 week randomised, double-blind, vehicle (placebo) controlled study designed to evaluate the safety and access for any treatment effects of BTX 1204 in patients with mild to moderate atopic dermatitis
  • The study is being conducted in four leading Australian dermatology clinics, in conjunction with some of Australia’s leading dermatology key opinion leaders
  • Botanix has been able to accelerate the addition of the BTX 1204 study by leveraging previous clinical data from Botanix’s acne program, as BTX 1204 utilises the same active drug and topical application platform as BTX 1503
  • Following the Phase 1b study, Botanix plans to file an application with the US FDA allowing a multicentre Phase 2 safety and efficacy study for BTX 1204 to potentially commence later in CY2018

Pipeline product: BTX 1308 (Psoriasis) and BTX 1801 (undisclosed)

  • Botanix continues to advance its pipeline products
  • Accelerated development of BTX 1308, a novel treatment for psoriasis, as it leverages data from the BTX 1503 program, utilises the same PermetrexTM delivery technology, with no need to repeat early studies
  • Botanix plans to take BTX 1308 into a Phase 1b study in 3Q CY2018
  • Botanix continues to complete BTX 1801 pre-clinical testing