Botanix poised to kick-off new study with CBD-based atopic dermatitis treatment

Botanix Pharmaceuticals (ASX: BOT) has now enrolled all patients required to kick-off its phase 1b atopic dermatitis study where it will test is cannabidiol-based BTX 1204 topical treatment.

The enrolment was completed ahead of targets due to “significant” interest from patients.

BTX 1204 uses the same active drug and Permetrex topical application delivery technology as the company’s cannabidiol-based BTX 1503 acne treatment, which yielded positive results in its phase 1b study.

“We are pleased to complete enrolment of the BTX 1204 atopic dermatitis study, which comes on the heels of the successful phase 1b study for acne, which we successfully completed in the first quarter of 2018,” Botanix executive director Matt Callahan said.

Under the phase 1b study for BTX 1204, 36 patients with mild-to-moderate atopic dermatitis will be treated for four weeks at four Australian dermatology clinics. Patients will be either be given the BTX 1204 or a placebo during the trial.

Mr Callahan said the data from the study would be available by the end of the current quarter.

Atopic dermatitis

A common and often relapsing condition, atopic dermatitis presents as a chronic inflammatory skin disorder where sufferers have an inflamed and itchy rash that lasts for more than 14 days.

Botanix estimates 25 million people in the United States suffer from the condition, with up to 18% of sufferers being infants and children.

Eucrisa was recently approved to treat the disorder but prior to that no new drugs have been developed for 15 years based on phase 3 studies.

According Botanix, during clinical studies, Eucrisa had “little to know impact on itch”.

Prescriptions for atopic dermatitis market currently bring in more than US$8 billion in sales each year around the world.

Botanix claims supporting scientific data indicates its BTX 1204 could treat more aspects of atopic dermatitis than more recently approved treatments such as Eucrisa.

Data suggests BTX 1204 may inhibit skin cell proliferation and associated immune responses as well as addressing inflammation and bacterial infection.

Next steps

Once phase 1b has been completed, Botanix will file an investigational new drug application with the US Food and Drug Administration to progress to a phase 2 safety and efficacy study.

Botanix anticipates starting this study in the latter half of the year.

In conjunction with progressing BTX 1204, Botanix is advancing BTX 1503, which resulted in a 47% decrease in acne lesions for participants by the end of a recent four week study. Additionally, patients reported the reduction in acne had been maintained a week after the study had finished.

Shares in Botanix closed today unchanged at A$0.125.