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On 25 January 2019, biopharmaceutical dermatology company, Botanix Pharmaceuticals Limited (ASX:BOT) announced that it had completed its Investigatorâs Meeting for the BTX 1204 Phase 2 atopic dermatitis clinical study with investigating dermatologists and study site coordinators.
Founder and Executive Director of Botanix, Matt Callahan stated that: The company is overwhelmed with the feedback at the Investigatorâs Meeting regarding the potential for BTX 1204 to provide innovative and safe treatment for moderate atopic dermatitis. The company is confident for an excellent start to registration for the Phase 2 study given the experience and quality of the study sites participating in the study and the positive response from the meeting attendees.Â
Investigatorâs Meeting for the BTX 1204 Phase 2 atopic dermatitis clinical study was conducted in Sydney, Australia and saw the participation of the study investigators and site planners from more than 13 dermatology clinics across Australia and New Zealand to discuss the study protocol, the feasibilities of drug application, as well as specific directives on patient assessment tools that will be used for the study outcomes.
The feedback from the meeting, with more than 40 attendees, has been very constructive regarding the data from the completed Phase 1B atopic dermatitis patient study and the study strategy. The evaluation of the innovative Permetrex⢠BTX 1204 formulation has proven to evade the burning and stinging related to recently approved topical products.
The enrolment of patients is swiftly accelerating (targeting at ~ 200 patients) as additional dermatology clinics in the US, and Australia are expected to join the study this quarter. The BTX 1204 Phase 2 atopic dermatitis clinical study is a randomized and vehicle-controlled study to assess the safety and effectiveness of BTX 1204 in atopic dermatitis patients for 12 weeks. The funds have been entirely sourced, and the research is anticipated to be fully recruited in the 3rd quarter of 2019.
Botanix Pharmaceuticals is a biopharmaceutical company engaged in offering therapeutic and advanced drug for the treatment of skin diseases such as acne, psoriasis and atopic dermatitis. The most common and long-lasting (14 days or more) kind of eczema, Atopic dermatitis is a chronically relapsing inflammatory skin disorder characterized by severing skin inflammation and itching. It has been noticeably under-diagnosed due to the lack of appropriate operative systemic agents, and limitations of current topical agents. The gross annual sales value for atopic dermatitis treatment is projected to be more than USD 4billion and further predicted to reach over USD 6billion by next three years, as suggested recently by Bell Potter research estimates.
The Company is focussing on potential licensing and strategic opportunities upon the successful completion of the study. Studies depict that Eucrisa®, recently approved drug for atopic dermatitis, has no significant impact on skin itching. BTX 1204 potentially has a broader scope of effectiveness than Eucrisa®, as suggested by Phase 1B BTX 1204 results.
Post the announcement, BOT stock soared by 1.163%, trading at A$0.087 (as at 1:40 PM, 25 January 2019) with a market capitalization of A$65.14 million and 757.42 million outstanding shares. The shares have gained upward momentum in last one month offering 24.64% return and the YTD return of 17.81% to its investors till date.
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