Slide 1: BTX 1204 atopic dermatitis study results presentation
ASX/Media Release 7 June 2018 BTX 1204 atopic dermatitis study results presentation Philadelphia PA and Sydney Australia, 7 June 2018: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “The Company”) is pleased to release a presentation containing supplementary infor
Slide 2: Rapid clinical development strategy and contacts
Botanix pursues a rapid clinical development strategy aimed at accelerating product commercialisation. The patient treatment duration of clinical studies is generally completed within a 4 to 12 week timeframe. The Company successfully completed its first patient studies with it’s lead product, BTX 1
Slide 3: BTX 1204 atopic dermatitis Phase 1b results: supplementary information
BTX 1204 atopic dermatitis Phase 1b results: supplementary information June 2018 1
Slide 4: Company investment highlights
Company investment highlights Botanix is an emerging global dermatology company with 2 advanced clinical programs and a strong pipeline Dermatology Targeting multi-billion dollar prescription markets for acne (with no new products approved Focused in the last 20 years) and atopic dermatitis (US$7bn
Slide 5: Atopic dermatitis disease overview
Atopic dermatitis disease overview Atopic dermatitis (AD) is a chronically relapsing skin disorder with an immunologic basis, but for which environmental factors (allergens, stress, food and skin flora) all play a part Disease pathology and common treatments • The exact cause of AD is unknown, but l
Slide 6: BTX 1204 Phase 1b atopic dermatitis patient study
BTX 1204 Phase 1b atopic dermatitis patient study Successful 4-week, double-blind, vehicle controlled patient study concluded in June 2018 Design Endpoints • 37 subjects 18 years and older: • Primary endpoints: – 25 on BTX 1204 / 12 vehicle – Safety – 32 patients completed the study – Adverse effect
Slide 7: BTX 1204 Phase 1b study results
BTX 1204 Phase 1b study results After only 4 weeks of treatment, study data indicated BTX 1204 was twice as effective over the vehicle (with efficacy still increasing) and substantial improvement in the key signs of AD observed Treatment success (%)1 Key takeaways 40% Efficacy still increasing at 4
Slide 8: BTX 1204 Phase 1b study results
BTX 1204 Phase 1b study results Substantial reduction in key signs of AD, provides confidence that unmet needs in AD (itch / inflammation) can be addressed Treatment Success1 Substantial reduction in the key signs of AD2 Erythema Exudation Lichenification 0 (0.2) (0.4) (0.6) (0.8) BTX 1204 Vehicle E
Slide 9: BTX 1204 study data in context
BTX 1204 study data in context Study data highlights the potential for BTX 1204 to continue to increase in efficacy after 4 weeks compared to competitive products, without their attendant side effects Treatment success1 across treatment period (%) Comparison with other FDA approved products 40% Base
Slide 10: Positioning and opportunity post Phase 1b study data
BTX 1204 positioning and opportunity post Phase 1b study data Botanix is targeting efficacy improvements with much better safety profile than monoclonal antibodies (Dupixent®), TCI’s (Protopic®) and high potency steroids, with new benefits in inflammation and itch reduction BTX 1204 has shown potent
Slide 11: Proposed BTX 1204 Phase 2 study design
Proposed BTX 1204 Phase 2 study design 10-12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate AD1 Design Endpoints • 3 dose groups: ~270 subjects • Primary endpoints: – High Dose twice a day: ~90 subjects – Proportion o
Slide 12: BTX 1204 next steps
BTX 1204 next steps Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues • Development program leverages existing data from BTX 1503 acne studies • Preparation of FDA regulatory package for Phase 2 clinical trial approval well
Slide 13: Company upcoming milestones
Company upcoming milestones Significant clinical and operational milestones across multiple programs expected over the next 12 months Indicative activities and milestones 2Q CY2018 3Q CY2018 4Q CY2018 1Q CY2019 2Q CY2019 First patient enrolled in Phase 2 trial BTX 1503 Acne Phase 2 multi-centre acne
Slide 14: Disclaimer
Disclaimer This presentation prepared by Botanix Pharmaceuticals Limited ("Company") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any
Slide 15: Contact us
Contact us Matt Callahan Visit us Botanix Pharmaceuticals www.botanixpharma.com Executive Director Follow us on social media P: +1 215 767 4184 E: mcallahan@botanixpharma.com 13 Botanix Pharmaceuticals Limited (ASX:BOT)