Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — 2nd Dermatology Drug Development Summit Europe 2021
26 slides from Botanix Pharmaceuticals's conference presentation, Feb 19, 2021
Slide 1: Botanix attends 2nd Dermatology Drug Development Summit Europe
19 February 2021 Botanix attends 2nd Dermatology Drug Development Summit Europe For personal use only Philadelphia PA and Sydney Australia, 19 February 2021: Clinical stage cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to announce Matt Callahan,
Slide 2: Contact and Cautionary Note on Forward-Looking Statements
For more information, please contact: General enquiries Investor enquiries Media enquiries Corporate Communications Joel Seah Haley Chartres Botanix Pharmaceuticals Vesparum Capital H^CK For personal use only P: +61 8 6555 2945 P: +61 3 8582 4800 P: +61 423 139 163 investors@botanixpharma.com botani
Slide 3: Unlocking the potential of synthetic cannabinoids
For personal use only Unlocking the potential of synthetic cannabinoids 2nd Dermatology Drug Development Summit Europe February 2021 www.botanixpharma.com
Slide 4: Overview of Botanix
Overview of Botanix For personal use only Pharma focused Leading pharmaceutical company leveraging unique properties of synthetic cannabinoids, including cannabidiol (CBD) Antimicrobial opportunities Dermatology opportunities Novel antimicrobial platform with positive Targeting key dermatology indic
Slide 5: Advanced Clinical Pipeline
Pharma focused Synthetic Cannabinoids Advanced Clinical Pipeline For personal use only Ph 1 Ph 1b Ph 2 Ph 3 Status Planning underway BTX 1503 for Phase 3 clinical Acne studies BTX 1801 Positive Phase 2a Antimicrobial study outcome Targeting initiation of BTX 1702 Phase 1b study in 1H Rosacea CY2021
Slide 6: Synthetic Cannabinoids are well suited to treat Skin Diseases and Infections
Pharma focused Synthetic Cannabinoids are well suited to treat Skin Diseases and Infections For personal use only Botanix’s studies show synthetic cannabinoids: Safe and well tolerated Broad anti-inflammatory properties relevant to infections Strong and consistent impact on inflammatory lesion
Slide 7: Background: Anti-microbial resistance and cannabinoids
Background For personal use only Anti-microbial resistance and cannabinoids
Slide 8: No new antibiotics have been discovered in over three decades
ANTIMICROBIAL No new antibiotics have been discovered in over three decades No new approved class of antibiotics has been discovered since 1984 and no new class of antibiotics has For personal use only been discovered to treat Gram-negative bacteria since 1962 Number of antibiotic classes discovered
Slide 9: CBD is a broad-spectrum Gram-positive antibiotic
CBD is a broad-spectrum Gram-positive antibiotic CBD is a powerful new antibiotic that is effective against a range of problematic Gram-positive bacteria at For personal use only MICs comparable to currently approved antibiotics1,2,3 100 Gram-Negative Fungi Gram-Negative Anaerobes Acinetobacter baum
Slide 10: Remarkable activity against MRSA without inducing resistance
Remarkable activity against MRSA without inducing resistance For personal use only CBD shows remarkable activity against 132 isolates of S. aureus and MRSA1 Antibiotic Minimum Inhibitory Concentration (MIC) comparison1 S. aureus all isolates (mg/mL) MRSA (mg/mL) MSSA (mg/mL) Antibiotic MIC50 MIC90 R
Slide 11: Unique mechanism of action – bactericidal
ANTIMICROBIAL Unique mechanism of action – bactericidal Novel mechanism of action with unique ability to rapidly kill bacteria without allowing resistance to develop For personal use only Mupirocin – targets only protein synthesis1 CBD – MRSA bacteria dead within 10 minutes2 Control CBD CBD – affect
Slide 12: Novel Mechanism of Action Confirmed
ANTIMICROBIAL Novel Mechanism of Action Confirmed The time-lapse shows CBD causes rapid permeabilization of the bacterial membrane and cell death For personal use only S.aureus treated with 2.5% methanol (negative control)1 S.aureus treated with synthetic cannabidiol1 Staph bacteria treated Staph ba
Slide 13: Clinical data for BTX 1801 and implications for dermatology
Clinical data for BTX 1801 and For personal use only implications for dermatology
Slide 14: BTX 1801 – First CBD-based program to receive QIDP
ANTIMICROBIAL BTX 1801 – First CBD-based program to receive QIDP For personal use only Strict QIDP criteria: FDA QIDP creates multiple commercial benefits Requires provision of a detailed package of data Exclusivity Priority Fast track Must be a novel product 5 additional years of Eligible for a
Slide 15: BTX 1801: Phase 2a Clinical Study Successfully Completed
ANTIMICROBIAL BTX 1801: Phase 2a Clinical Study Successfully Completed For personal use only Study update Study design Phase 2a study completed in 4Q CY20 Double-blind, vehicle-controlled Phase 2a clinical study Positive top-line data announced 1Q CY21 4 dose groups: 66 healthy volunteers:
Slide 16: Phase 2a study: Successful at eradicating Staph
ANTIMICROBIAL Phase 2a study: Successful at eradicating Staph1 For personal use only BTX 1801 met study end points Safe and well tolerated at doses up to 20% drug active All 66 participants successfully completed the BTX 1801 study Safety & No severe adverse events reported2 tolerability Eff
Slide 17: Phase 2a study data: staph eradication
ANTIMICROBIAL Phase 2a study data: staph eradication World first human data demonstrating synthetic CBD has clinical utility as an antimicrobial agent For personal use only BTX 1801 Ointment: Staph eradication rates (% of participants)1 BTX 1801 Gel: Staph eradication rates (% of participants)1 80%
Slide 18: Phase 2a study data: context
ANTIMICROBIAL Phase 2a study data: context For personal use only Destiny Pharma (XF-73): Staph eradication rates (% of participants)1 80% 5 day Staph eradication rates (% of participants) treatment period Destiny XF-73 study examined eradication at day 6 (i.e 1 60% day after treatment period) and
Slide 19: Significant upside potential – Multiple AMR Opportunities
ANTIMICROBIAL Significant upside potential– Multiple AMR Opportunities For personal use only Dialysis related infections … further novel cannabinoid work underway from catheter usage Awarded Innovation Connection Grant2 to accelerate the C. Diff (Clostridium Difficile) medicinal chemistry prog
Slide 20: Potential for synthetic CBD in dermatology
ANTIMICROBIAL Potential for synthetic CBD in dermatology – Safe and effective antimicrobial and anti-inflammatory For personal use only Impetigo Cellulitis Folliculitis Acne Corynebacterium Streptococcus Bacillus subtilis S. Aureus S. epidermis MRSA. Cutibacterium minutissimum Erysipelas Dermatitis
Slide 21: Other clinical programs for synthetic CBD in dermatology
Other clinical programs for For personal use only synthetic CBD in dermatology
Slide 22: BTX 1702: Phase 1b Rosacea Study: commencing 1H 2021
DERMATOLOGY BTX 1702: Phase 1b Rosacea Study: commencing 1H 2021 For personal use only Study design Four dose groups, ~120 patients: Endpoints: – BTX 1702 high dose - twice daily: 40 patients – Safety and tolerability – BTX 1702 low dose - twice daily: 40 patients – Change in inflammatory lesion
Slide 23: BTX 1503: Successful End-of-Phase FDA Meeting
DERMATOLOGY BTX 1503: Successful End-of-Phase 2 FDA Meeting For personal use only Study update Sizable acne prescription market End of Phase 2 meeting with FDA successfully completed The global acne market expected to reach US$7bn by 20242 FDA highlighted excellent safety profile of BTX 1503, an
Slide 24: Executing on Key Near-Term Milestones
NEAR-TERM CATALYSTS Executing on Key Near-Term Milestones For personal use only Antimicrobial: BTX 1801 Phase 2a study completion Positive results announced Rosacea: BTX 1702 Phase 1b study start Targeting study start in 1H CY2021 Acne: BTX 1503 planning for Phase 3 clinical studies Pending co
Slide 25: Disclaimer
DISCLAIMER For personal use only Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,”
Slide 26: For personal use only
For personal use only General enquiries Botanix Pharmaceuticals Corporate communications +61 8 6555 2945 investors@botanixpharma.com www.botanixpharma.com
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