Botanix held a Pre-IND Meeting with the FDA for the BTX 1204 atopic dermatitis product
Key highlights
· Botanix held a Pre-IND Meeting with the FDA for the BTX 1204 atopic dermatitis product
· FDA confirmed that the proposed development plan and data package presented supported Phase 2 clinical development in the US
· The FDA also provided consensus on the overall drug development plan required for BTX 1204 to support a NDA
· Botanix is now well-placed to commence BTX 1204 Phase 2 clinical development in the US
Philadelphia PA and Sydney Australia, 30 August 2018: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or the “Company”) announced today that it has successfully held a Pre-Investigational New Drug (Pre-IND) Meeting with the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products for BTX 1204, its second clinical stage product for the treatment of atopic dermatitis.
To read the ASX announcement, please click here
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General Enquiries
Matt Callahan
Botanix Pharmaceuticals
Executive Director
P: +1 215 767 4184
E: mcallahan@botanixpharma.com
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Joel Seah
Vesparum Capital
P: +61 3 8582 4800
E: botanixpharma@vesparum.com
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Julia Maguire
The Capital Network
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E: julia@thecapitalnetwork.com.au
