Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (December 2016)
21 slides from Akari Therapeutics's investor presentation, Dec 6, 2016
Slide 1: December 2016
December 2016 NASDAQ: AKTX Copyright Akari Therapeutics, Plc 2016
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward - Looking Statements Certain statements in this presentation constitute "forward - looking statements" within the meaning of Section 27A of the Securit ies Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as "ant
Slide 3: Agenda
Agenda • Introduction – Dr. Gur Roshwalb • Phase 1b trial – Dr. Wynne Weston - Davies • Soliris ® resistance – Dr. Petra Muus • PNH – Dr. Anita Hill • Development pipeline – Dr. Gur Roshwalb • Coversin LA – Clive Richardson Copyright Akari Therapeutics, Plc 2016 2
Slide 4: Exploiting the Power of Nature: Coversin and Other Tick-Derived Proteins
Exploiting the Power of Nature: Coversin and Other Tick - Derived Proteins Advancing Clinical Program Daily To Weekly Dosing New Discovery Platform • Resistant patient successfully on therapy for 9 months • Phase 2 PNH patients identified; 90 day data expected March 2017 • Phase 3 expected to commen
Slide 5: Current Clinical Timeline
Phase 1 Phase 3 2018 2016 2017 Phase 2/3 Phase 3 Ongoing treatment/potential regulatory pathway Phase 3 Preclinical Phase 2 Phase 2 Current Clinical Timeline 2019 Eculizumab Resistance PNH aHUS GBS Coversin LA Phase 2 Copyright Akari Therapeutics, Plc 2016 4
Slide 6: PNH Phase Ib Trial: Daily Dosing Gives Full Ablation at Target Maintenance Dose
0 20 40 60 80 100 120 140 1 7 13 19 25 31 37 43 49 55 61 67 73 79 85 91 97 103 109 115 121 127 133 139 145 151 157 163 169 175 181 187 193 CH50 U Eq/L Hours PNH Phase Ib Trial: Daily Dosing Gives Full Ablation at Target Maintenance Dose • Subjects received ablating 4 injections 12 hourly for 2 days,
Slide 7: PNH Phase Ib Trial: Alignment of CH50 Elisa and Lytic Results
PNH Phase Ib Trial: Alignment of CH50 Elisa and Lytic Results* Time from first dose (h) 0 20 40 60 80 100 120 0 24 48 72 96 120 144 168 192 CH50 U Eq /ml Lytic CH50 0 20 40 60 80 100 120 0 24 48 72 96 120 144 168 192 Placebo Last Coversin dose Placebo Cohort 1 (30 mg) Cohort 2 (22.5 mg) Cohort 1 (30
Slide 8: Dr. Petra Muus
Dr. Petra Muus Internist Hematologist PNH Expert Center, Dept Hematology , Radboudumc Nijmegen, the Netherlands • Dr. Saskia Langemeijer , internist hematologist • Dr. Marten Nijziel , internist hematologist • Dr. Saskia Schols , internist hematologist • Ankie Sneek , dedicated PNH nursing team • In
Slide 9: Successful Treatment of Eculizumab-Resistant Patient
0 20 40 60 80 100 120 140 0 200 400 600 800 1,000 1,200 1,400 1 11 21 31 41 51 61 71 81 91 101 111 121 131 141 151 161 171 181 191 201 211 221 231 241 251 261 LDH CH50 Successful Treatment of Eculizumab - Resistant Patient • Eculizumab - resistant PNH patient treated*since February ‒ Continues to se
Slide 10: Resistant Patient: No Neutralizing Antibodies to Date
Resistant Patient: No Neutralizing Antibodies to Date Coversin 0 20 40 60 80 100 120 PNS Anti-Cov Rb Day 0 Day 16 Day 34 Day 58 Day 83 Day 125 Day 153 Day 181 Day 205 Day 237 Anti-Cov Rb % inhibition of lysis • Antibody first detectable after 2 weeks • Response peaks at 9 weeks, then declines to sta
Slide 11: Dr. Anita Hill
Dr. Anita Hill Dr. Anita Hill MBChB (Hons), MRCP, FRCPath , PhD • Lead investigator COBALT • Consultant Haematologist, Honorary Associate Professor, and Clinical Lead, National PNH Service & Leeds Teaching Hospitals • Former Consultant Haematologist and Clinical Lead for Bradford Teaching Hospitals
Slide 12: Potential Advantages of Coversin
Potential Advantages of Coversin • Subcutaneous delivery • CH50 control on a daily basis • LTB4 benefits / thrombosis • Tissue penetration • Activity even in p.Arg885His mutation / resistant patients Copyright Akari Therapeutics, Plc 2016 11
Slide 13: PNH Phase 2 and Phase 3
PNH Phase 2 and Phase 3 • Trial initiation expected summer 2017 • Working with network of leading PNH centers • Undergoing scientific advice with EMA & FDA Phase 2 Ongoing Phase 3 2017 • Full data expected March 2017 • Leading PNH treatment centers in EU • Primary efficacy endpoint: LDH at 28 days •
Slide 14: Akari Discovery Platform: Pipeline of tick-derived molecules
Pipeline of tick - derived molecules selected to suppress mediators of chronic inflammation in wide range of orphan disorders Exploiting The Power Of Nature: Akari Discovery Platform Coversin engineered molecules targeted to complement pathway New Akari tick - derived anti - inflammatory molecules •
Slide 15: Benefits of Nature-Derived Platform From Tick-Based Compounds
Benefits of Nature - Derived Platform From Tick - Based Compounds • 300 million years of development • Predominantly lipocalins – Stable – Easily engineered • Ligand capture • Tight binding • Ability to engineer Copyright Akari Therapeutics, Plc 2016 14
Slide 16: Once-Weekly Formulation Coversin LA
Once - Weekly Formulation Coversin LA • Addition of 600 Pro - Ala - Ser amino acids (PASylation ™ ) • Increases MW from 17 to 68 kDa – Apparent ~600 kDa MW • No toxicity in rat model at high multiple of expected maintenance dose in man • Terminal half life based on mouse and rat models, est. at 4 da
Slide 17: Tissue Targeting Coversin Program
Tissue Targeting Coversin Program • Coversin targeted to specific tissues by fusing peptides to N - terminal • First condition is myasthenia gravis (MG) – Neuromuscular junction (NMJ) using targeted aptamer – Dose expected to be <20% of that for other C5 indications – Potential benefits: ▪ Reduced i
Slide 18: Coversin Tissue Targeting: NMJ
• Coversin linked to peptide which binds laminin γ1 ‒ Differentially concentrates at basal lamina of NMJ • Immunohistochemical analysis in mice shows that Coversin - laminin construct – unlike Coversin alone - concentrates to NMJ of diaphragm and tibialis muscles Coversin Tissue Targeting: NMJ • No
Slide 19: Coversin Dual Action Additive Benefit C5 + LTB4
Coversin Dual Action Additive Benefit C5 + LTB4 Roversi P et al. J Biol Chem 288: 18789; 2013 Immune - Complex Mediated Acute Lung Injury Mouse Model Significant decline in inflammatory markers Complement and LTB4 - equal & additive roles * Proteins only ** LTB 4 (0:1, outer) or ethanol (0:0, centra
Slide 20: Q&A
Q&A Copyright Akari Therapeutics, Plc 2016 19
Slide 21: December 2016
December 2016 NASDAQ: AKTX Copyright Akari Therapeutics, Plc 2016
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