Botanix Pharmaceuticals Obtains Ethics Approval: BTX 1204 Phase 2 Atopic Dermatitis Study

As per recent ASX announcement on 18th December, biopharmaceutical company Botanix Pharmaceuticals Limited (ASX: BOT) was successful in obtaining ethics approval for its BTX 1204 Phase 2 atopic dermatitis study. The company will now begin with recruitment and treatment of first patients in Australia and plans to begin enrolment in the US by next year.

Botanix Pharmaceuticals

Botanix Pharmaceuticals Limited is a biopharmaceutical dermatology company. The company was listed in 1985 and is based in Perth, Australia. It aims at targeting multi-billion-dollar prescription markets for acne, psoriasis and atopic dermatitis. The company is undergoing various studies to test the effectiveness of pharmaceutical ingredient known as cannabidiol for the treatment of certain skin diseases.

Clinical studies

The Phase 2 atopic dermatitis clinical study is 3 months randomised, double-blind, vehicle-controlled study to ascertain the safety and efficacy of BTX 1204 in patients with moderate atopic dermatitis.  The company will recruit around 200 patients across 2 dose groups, involving leading dermatology clinics across the US and Australia.

The Company completed its first acne-based experimental study with BTX 1503 in January 2018. During the quarter ended September 2018, Botanix completed the Investigator’s Meeting for the BTX 1503 phase 2 clinical study.

It recently obtained approval for planned Phase 1B patient study of psoriasis product BTX 1308, expected to commence in 4Q CY2018 and will possibly take 3-4 months to complete. It is partnering with German-based clinical research firm BioSkin GMBH for the study.

The Phase 2 BTX 1204 study is in continuation with a month-long Phase 1b patient study completed in June 2018. The Phase 1b results indicated that BTX 1204 was twice as effective over the vehicle (or placebo) and demonstrated substantial improvement in the key signs of atopic dermatitis. Importantly, BTX 1204’s efficacy was still increasing at the 4-week timepoint, suggesting a longer treatment period enables BTX 1204 to potentially exceed industry performance.

Atopic Dermatitis

Atopic Dermatitis is a long-lasting and relapsing chronical skin disorder. Patients suffer severe rashes, inflammation and skin itching. Approximately 25 million people in the US are suffering from this skin disease.

Evidence depict that the drug Eucrisa has an extremely mild impact on skin irritation and itching for atopic dermatitis patients. The BTX 1204 Phase 1b patient study results suggest that BTX 1204 potentially has a broader mechanism of action than Eucrisa.

As stated by Executive Director Matt Callahan, the company is pleased to commence the second phase 2 program within six months. It is extremely confident of the effectiveness of BTX 1204 in treating chronic skin ailments. The clinical studies conducted by the company highlight its deliberate efforts to tap atopic dermatitis market, larger and faster growing than acne market.

Recently the medical company announced the receipt of the R&D Tax Incentive Fund of AUD 4.6 million which will be invested in the development of Botanix’s product expansion and business development.

 Stock performance:

The Botanix stock provided decent YTD return of around 17%. However, the company’s shares are down over the last six months generating a negative return of -39%. The shares are currently trading at a price of $0.072 (up 2.8% as at December 18, 2018, 2:35 PM AEST) with a market capitalization of $53.02 million.


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