JBPOS0101: A New Generation mglur- and BBB- Targeted AED for the Treatment of Super-Refractory Status Epilepticus (SRSE)
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1 JBPOS0101: A New Generation mglur- and BBB- Targeted AED for the Treatment of Super-Refractory Status Epilepticus (SRSE) Bio-Pharm Solutions Co., Ltd. Yongho Kwak, Ph.D. Director of Pharmacology 1
2 Who We Are Bio-Pharm Solutions Co., Ltd. is a privately-owned drug discovery and development company based in South Korea Dr. Yong Moon Choi, CEO, has a track record in the field of epilepsy, including orphan epilepsies: - Involved in the development of Felbamate, currently used in the treatment Lennox-Gastaut Syndrome - Invented YKP3089, currently in late-stage clinical development at SK for refractory partial-onset seizures - Invented Carisbamate, a drug candidate for refractory partialonset seizures which reached the NDA stage 2
3 JBPOS0101 Overview of SRSE A unique mechanism of action (metabotropic glutamate receptors) not presently associated with currently-used antiepileptic drugs Potent efficacy in the pharmaco-resistant status epilepticus (BDZ-resistant) Antiepileptogensis through suppressing spontaneous recurrent seizures Neuroprotection through blocking hemorrhages in the blood-brain barrier (BBB) of treatment-naive rats Potent anticonvulsant properties in a broad spectrum of epilepsy models Applications of JBPOS0101 go beyond orphan indications - JBPOS0101 has potential applications in infantile spasms based on preclinical pharmacology 3
4 Prevalence of Status Epilepticus Reported to be between / 100,000 Assuming a population of about 322,000,000, there are up to about 130,000 individuals with status epilepticus in the United States An estimated 15% of all cases of status epilepticus will become super-refractory* *Shorvon and Ferlisi, Brain, 2011, 134:
5 Disease Overview: Super-Refractory Status Epilepticus Status epilepticus (SE) is defined as continuous seizure activity for 5 min One-third of patients with refractory and super-refractory SE will die, and another one-third will suffer chronic neurologic or other deficits No approved treatments for super-refractory SE at this time Early SE Treat with 1 st line AEDs (benzodiazepines) Modified from Shorvon and Ferlisi, Brain, 2011, 134: min Established SE Treat with 2 nd line AEDs (phenytoin, phenobarbital, valproate, etc.) min Refractory SE Treat with 3 rd line general anesthesia (propofol, midazolam, etc.) > 120 min Super-Refractory SE Failure to terminate SE after weaning 3 rd line treatment 5
6 JBPOS0101 s Efficacy in Lithium-Pilocarpine-Induced SE JBPOS0101 injection Time Injection route Observation time after seizure onset Prevention 2 h before seizure induction Intervention At seizure onset Intervention (Benzodiazepineresistant) 30 min after seizure onset Intervention (Benzodiazepineresistant) 30 min after seizure onset ip iv iv ip 90 min 90 min 90 min 90 min ED 50 (mg/kg) JBPOS0101 shows potent efficacy in benzodiazepine-resistant SE 6
7 Efficacy of JBPOS0101 in Benzodiazepine-Resistant Electrographic SE Benzodiazepine-resistant electrographic status epilepticus rat model: Gamma wave power (20-70 Hz) on EEG for 10 hours *Lehmkuhle et al., J Neurophysiol, (3): Conducted by: NINDS Anticonvulsant Screening Program 75 mg/kg 125 mg/kg Solid line: mean, Shaded area: 95% confidence intervals, Mann-Whitney U-test, *p<0.05 JBPOS0101 suppresses benzodiazepine-resistant electrographic SE 7
8 Antiepileptogenic Effect of JBPOS0101 Following Benzodiazepine-Resistant SE Monitoring of spontaneous recurrent seizures for 14 days JBPOS0101 suppresses spontaneous recurrent seizures and shows evidence of antiepileptogenesis 8
9 Survival Rate and Body Weight in Lithium-Pilocarpine-Induced SE Survival Rate and Change in Body Weight for 14 days Survival rate Body weight Normal vs. 100 mg/kg: No Statistical difference Data were represented as mean ± S.E.M. Statistical analysis were performed by Two-way ANOVA test and followed Bonferroni Test as a post hoc analysis using Prism JBPOS0101 improves survival rate and body weight in SE 9
10 BBB Hemorrhages caused by Lithium-Pilocarpine-Induced SE Examples of HE staining showing BBB hemorrhages 12 Hr Numbers Areas Sum Areas Avg. * p<0.05, ** p<0.01, brain sections/rat, n=6 for each group 24 Hr JBPOS0101 reduces the number and size of hemorrhages in the BBB caused by SE 10
11 Neuroprotective Effect of JBPOS0101 in Benzodiazepine-Resistant SE Status epilepticus-induced hippocampal cell loss after 14 days JBPOS0101 protects hippocampus against status epilepticusinduced cell death 11
12 Effect of JBPOS0101 in SE-Induced Memory Deficits Assessment of spatial memory and learning in SE-induced rats in the Morris Water Maze Conducted by: NINDS Anticonvulsant Screening Program Two-way ANOVA with Bonnferoni s multiple comparison test, *p<0.05 JBPOS0101 improves spatial memory and learning functions in rats with SE 12
13 Comparison of Antiepileptic Activity in Animal Models Compounds JBPOS0101 MES (ip) (po) PTZ (ip) Mice scbic (ip) scpic (ip) Stry- Chnine (ip) ED 50 (mg/kg) MES (po) PTZ (po) Li-Pilo Rats Prevention (ip) Li-Pilo Intervention (iv) TD 50 (po) (ip) Allopregnanolone > >300 >40 > (ip) Levetiracetam > 500 > >500 NA >500 NA NA >500 Phenytoin 5.64 >50 >50 >50 NA 28.1 >500 NA NA > 1000 Valproic acid NA NA NA 784 Vigabatrin > > NA NA NA NA > 250 (ip) NA Lamotrigine 7.47 >40 >40 > (po) 1.3 >412 NA NA 411 Topiramate 33 >800 >500 >500 NA 15.8 >1000 >40 NA >2000 Felbamate > NA 25.3 NA 80.5 NA >300 Pregabalin NA 1.8 NA NA NA NA JBPOS0101 shows broad spectrum and potent efficacy NA: Not Available 13
14 Phase 1 Trial: Safety, Tolerability, and PK in Young Healthy Subjects Phase 1 Protocol Approved by US FDA and Health Canada and conducted in Toronto, Canada Single Dose: mg, 64 subjects (8 subjects/8 groups, 6 active/2 placebo) Multiple Dose: mg per day for 10 days, 24 subjects (8 subjects/3 groups, 6 active/2 placebo) Phase 1 Results No effects on vital signs PK data shows a dose-dependent linear relationship (Cmax, AUC) Half-life (T 1/2 ) = h Mild/transient adverse effects at the highest doses: headache, somnolence, dizziness, euphoria Very well tolerated by phase 1 volunteers 14
15 Summary JBPOS0101 New AED with novel mechanisms Active in models of pharmaco-resistant status epilepticus Evidence of antiepileptogenic & neuroprotective activity Broad spectrum of antiepileptic activity Other indications: neuroprotection, pain, anxiety, and depression Current plan Super-refractory status epilepticus - Phase II study (open-label, single-center, adjunctive therapy) - Will be performed in USA and South Korea - Phase II study initiation in 2017 Infantile spasms - Protocol development/us FDA meeting preparation in progress Response to treatment can be assessed quickly for both clinical trials 15
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