Notably, the study enrolment was completed in advance of Botanix management’s initial target, underpinned by significant interest from patients in joining the study.
Botanix is developing BTX 1204, a new treatment for mild to moderate atopic dermatitis, also known as eczema.
The company remains on track to release phase Ib results in June quarter of 2018.
Targeting a market worth US$8 billion in annual sales
Atopic dermatitis is a common chronic inflammatory skin disorder and the prescription market generates more than US$8 billion in annual sales globally.
Patients display achronic rash characterised by inflammation and itching with symptoms lasting 14 days or more.
Before the recent approval of Eucrisa® (crisaborole), there had been no new drugs approved for atopic dermatitis for more than 15 years.
Competing treatment has little to no impact on itch
Notably, clinical studies showed that Eucrisa® had little to no impact on itch, which remains a key unmet need for atopic dermatitis patients.
Potential to move to phase II this year
Following completion of this study, Botanix plans to file an Investigational New Drug (IND) application with the FDA.
This will allow a multicentre phase II safety and efficacy study for BTX 1204 to potentially commence later in December half of this year.