6/20/2018. A Public Benefit Corporation. A First-in-Class Snakebite Antidote. Discovery to Accelerated Development

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1 A Public Benefit Corporation A First-in-Class Snakebite Antidote Discovery to Accelerated Development 1) Introduction - 5 min 2) Introduction of Ophiex 15 min 3) Ophiex's snake research 60 min 4) Introduction of Shionogi 15 min 5) Brief summary of Shionogi's spla2 program conducted in the past - 15 min 6) AOB - 15 min Matthew R. Lewin, MD, PhD s: matt@ophirex.com mlewin@calacademy.org SOMA Conference 16 May

2 Snakebite is an occupational hazard of scientific expeditions and many others United States: ~10,000 venomous bites/year 5 2

3 Every time the blood pressure cuff inflates I jump. I guess it s a little PTSD 6 22 y.o. soldier bitten by an adder during training exercises in Germany 7 3

4 GENESIS THE UNMET NEED: No Field Antidotes Exist 2001: California Academy Scientist Dr. Joe Slowinski was killed by a snake s bite in SE Asia while on expedition. No anti-venom was available. Heroic efforts to save him were unsuccessful. Dr. Slowinski s fatal krait bite 2011: Worried about snakebite while working on expedition to SE Asia and imagining what might be done in the same situation without antivenom: Could small molecule inhibitors work for snakebite without requiring a needle? >5 Million Snakebites Per Year >400,000 Amputations Per Year >125,000 Deaths Per Year >75% of deaths occur outside the hospital Anti-venom Limitations - Expensive - Requires Cold-Chain - Requires Hospital Facility - Global Shortages 8 Doctors Without Borders plea June 3,

5 Desirable Properties of a Field Antidote Safe Effective and with Adequate ½ life Broad Spectrum (Agnostic to venom type) Easy to Administer (Oral/IV, Compact) Deep tissue penetration Heat Stable Our Goal: Initiation of Treatment Any Snakebite, Anywhere, Any Time by Anyone -IV and Oral for Human Use -Veterinary-Use Formulations 5

6 First Target: spla2 An anti-pla2 [molecule] could fulfill almost all the criteria that describe an ideal antivenin: economically affordable; possess a long shelf-life under various storage conditions; zero allergenicity; synthetically manufactured. From Isbister, Air Force Research Laboratory Human Effectiveness Directorate Report: AFRL-HE-BR-TR Copyright 2017 Ophirex, Inc. 12 6

7 Discovery Plate (November 2014) Colorimetric enzyme test 20+ venoms initially tested against several candidate drugs. Darapladib (GSK) had no effect. Venom type Yale University S5920/LY HAS EXTREME POTENCY AGAINST 25 DEADLY VENOM SPLA2S FROM 6 CONTINENTS cobra krait Echis Russel Habu Venom + Control Prodrug S-3013 Flunixin S5920/LY S5920 Me-Varespladib DEDA. Lewin M. et al. Toxins

8 Repositioning LY & LY Proof of Drug Binding to Venom (Synonym: Varespladib, Me-Varespladib) More than 25 clinical trials Phase I to III -e.g. pancreatitis, SIRS, ACS No overt safety issues: Nearly 10,000 patients have been exposed to this drug Not sufficiently efficacious for indications Extremely potent spla2 inhibition Half-life ~5-7 hours Courtesy of Profs. Fontes, Lomonte, Gutierrez 17 8

9 LY315920/LY333013: Unprecedented Spectrum Pacific Coast Rattlesnake Saw-scaled Viper Mojave Rattlesnake South American Rattlesnake Russel Viper Coastal Taipan Saw-scale viper (Echis carinatus) European Viper Coral Snake NO GENUS of snakes kills more people and causes more economic damage than Echis. 19 9

10 Saw-scaled Viper Russell s Viper LIVE DIE Disintegrin 8% Disintegrin CRISP 7% 2% PLA2 8% Other 13% CTL 16% SP 8% SP 4% Other 7% PLA2 33% svmp 57% KuTi 12% svmp 25% 10

11 Coral snake Micrurus fulvius (M. fulvius) Pacific Coast Rattlesnake KLK 11% Other 6% PLA2 26% 3FTx 26% Crotam ine 46% Other 17% PLA2 68% 11

12 South American rattlesnake Coastal Taipan Rescue Mortality: Crotamine 19% SP 8% Other 9% PLA2 59% Coastal Taipan Bite (photo: David Williams) svmp 5% 12

13 Oral Antidote: Delayed Dose, 10mg/kg vs. Lethal Taipan envenomation Coastal Taipan (Australia) svmp 6% KuTi Other 8% 1% PLA2 85% 13

14 IV LY bolus: Rescue from Lethal coral snake envenomation Pig Study #1 POC IV and Oral Rescue from Lethal Envenomation IV: 5mg/kg bolus Oral suspension: 20mg/kg 29 14

15 Oral (LY333013): Rescue from Lethal coral snake envenomation Delayed administration of Oral Antidote Loading dose and then q8 hours x24 hours N=3 N=2 N=4 N=

16 LY maintains normal coagulation and muscle integrity in setting of Micrurus envenomation Conclusions Restoration of neurological function by an antidote appears to overturn long-standing dogma that presynaptic paralysis is irreversible A single molecule can restore neurological and some key hemostatic functions A field antidote to snakebite is well within reach and in many cases may be curative Addition of a metalloprotease inhibitor small molecule such as prinomastat could take us 2/3 of the way to complete antivenom replacement

17 Thank you! Bee venom control Lt. Col. Becky Carter Mr. Benjamin Chitty Ms. Jeanette Wolfe Eli Lilly & Co (Indianapolis) Shionogi (Osaka, Japan) 17

18 Surprise Finding: Efficacy vs. Bee Venom Venom Administered 15 minutes prior to oral antidote Rescue of experimentally envenomed mice by rapid infusion of single dose LY (N=5 each group). Implication: Host spla2 is as important as blocking the venom directly. 18

19 Venom +/- LY315920: Ex-vivo human blood 19

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