Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Technical Presentation (May 2020)
16 slides from Akari Therapeutics's technical presentation, May 1, 2020
Slide 1: Summary of Topline Phase II Results: Nomacopan for Treatment of Bullous Pemphigoid
April 2020 Copyright Akari Therapeutics, Plc – 2020 Summary of Topline Phase II Results Nomacopan for Treatment of Bullous Pemphigoid
Slide 2: Disclaimer
DISCLAIMER Certain statements in this presentation constitute contains “forward - looking” statements within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 . These forward - looking statements reflect our current views about our plan
Slide 3: Bullous Pemphigoid Significant Unmet Need
3 Bullous Pemphigoid Significant Unmet Need • Severe autoimmune blistering skin disorder primarily of the elderly, caused by immune complex mediated inflammation • No approved therapy. Current treatment with chronic corticosteroids poses substantial health concerns and 3 – 4 - fold increase in morta
Slide 4: Rationale for Nomacopan in BP: Preclinical Efficacy and Elevated C5a/LTB4
` LTB4 levels - human blister fluid C5a levels - human blister fluid Elevated levels of LTB4 and C5a indicate activation of complement and synthesis of LTB4 at sites of blister formation Rational for nomacopan in BP Preclinical Efficacy and Elevated C5a/LTB4 (in Human) Preclinical passive mouse mode
Slide 5: Phase II Study nomacopan in Bullous Pemphigoid
5 Phase II Study nomacopan in Bullous Pemphigoid
Slide 6: Bullous Pemphigoid Phase II Study Patients with Mild-to-Moderate Disease
6 Bullous Pemphigoid Phase II Study Patients with Mild - to - Moderate Disease Study design • Phase II Single arm (n = 9); 42 days treatment • Active bullous pemphigoid; newly diagnosed or recurrent Treatment • Nomacopan SQ dosing • Day 1 : 60 mg and 30 mg 12 hours later, Day 2 - 42 : 30 mg once dai
Slide 7: Summary of Fully Recruited Phase II BP Data
7 Summary of Fully Recruited Phase II BP Data Patient Demographics • 7 moderate and 2 mild BP patients; 5 female, 4 male; median age 75; median weight 89.4kg; median BMI 30.2 • Median Karnofsky score 80 (range 60 – 90) • 5 patients newly presenting BP and 4 relapsing disease • Typical comorbidities
Slide 8: Patient BPDAI Activity Scores (n=7) Excluding Two Non-Responders
8 0 10 20 30 40 50 60 -14 -7 0 7 14 21 28 35 42 BPDAI Total Activity Score Individual patients BPDAI activity Patient BPDAI Activity Scores (n=7) Excluding Two Non - Responders 101 - 003 201 - 001 202 - 001 204 - 001 201 - 002 101 - 005 101 - 007 0 5 10 15 20 25 30 35 40 45 -14 -7 0 7 14 21 28 35 42
Slide 9: Patient BPDAI Activity Scores Two Non-Responders
9 Patient BPDAI Activity Scores Two Non - Responders 0 10 20 30 40 50 60 -14 -7 0 7 14 21 28 35 42 BPDAI Activity score Days from first dose of nomacopan BPDAI Activity Score 101-004 206-002 • Both non - responders had long term relapsing disease on admittance • Combined decline in mean BPDAI activi
Slide 10: Concomitant Treatments
10 • Patients on BP typically are referred to a hospital and, as such, may be on treatment prior to dosing. Oral steroid treatments were an exclusion from the Phase II study – 5 out of 9 patients on treatment prior to nomacopan dosing – 3 were on topical clobetasol (a relatively strong tropical ster
Slide 11: Terminal Complement Activity - BP Patients
11 Terminal Complement Activity - BP Patients 0 50 100 150 200 250 0 7 14 21 28 35 42 49 56 63 70 77 CH50 U Eq/mL Days 101-003 201-001 202-001 101-004 204-001 201-002 101-005 101-007 206-002 • Ablating dose Day 1: 60mg and 30 mg 12 hours later • Maintenance dose: 30mg once daily until Day 42 Notes :
Slide 12: Key Phase II Conclusions
12 Primary Observations 1) Rapid clinical response on nomacopan 2) Quantum of response similar to potent oral steroids 3) Indications that remission may be achievable with 6 weeks of treatment 4) Supports a Phase III design of rapid steroid tapering 5) Good safety profile and well tolerated Unknowns
Slide 13: Therapeutic Approaches to BP
` Therapeutic Approaches to BP • Major unmet medical need of the elderly in aging patient population • No approved therapy for BP and no new treatment in last 40 years • BP treated with steroids increases risk of mortality compared to age - matched controls by ~3 - 4X; causes hospitalization/clinica
Slide 14: Nomacopan Inhibits Downstream Cytokine & Chemokine Signalling Cascades Implicated in BP
14 Nomacopan Inhibits Downstream Cytokine & Chemokine Signalling Cascades Implicated in BP Pathology Data adapted from: Figures 1, 2 and 3 of Huber - Lang et al, J Immunol. 2014; 192: 5324 – 5331 Notes : * value shown for MCP1 is scaled to10 - fold less than measured value to allow use of same y - a
Slide 15: BP: Gateway to Other Indications
15 Source: LEK 2018 Report BP: Gateway to Other Indications • Other autoimmune blistering skin diseases are categorized by auto - antibodies to either structural epidermal proteins or dermal - epidermal junction proteins • Symptoms follow that of BP and are generally moderate to severe • Generally,
Slide 16: Summary of Topline Phase II Results: Nomacopan for Treatment of Bullous Pemphigoid
April 2020 Copyright Akari Therapeutics, Plc – 2020 Summary of Topline Phase I I Results Nomacopan for Treatment of Bullous Pemphigoid
Akari Therapeutics — Technical Presentation (May 2020) on 6ix