YKP3089 Novel Neurotherapeutic
YKP3089 Novel Neurotherapeutic
YKP3089 Novel Neurotherapeutic
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>YKP3089</strong><br />
New Jersey, U.S.A.<br />
<strong>Novel</strong> <strong>Neurotherapeutic</strong><br />
Seoul, Korea<br />
Epilepsy Pipeline Update: Portal Into CNS<br />
San Francisco, California<br />
February 2526, 2010<br />
S. James Lee, PhD<br />
Daejeon, Korea<br />
Life Science<br />
Fair Lawn, New Jersey<br />
Shanghai, China
Efficacy Potential<br />
Clinical<br />
<strong>YKP3089</strong> Highlights<br />
• In addition to Broad spectrum Epilepsy, potential therapeutic for Neuropathic<br />
Pain, Bipolar Disorder, Anxiety, etc.<br />
Safety & Toxicity<br />
• High safety margin<br />
• Low QTc prolongation potential<br />
• Favorable PK profile: Once a day dosing<br />
• Low adverse effects<br />
Mechanism<br />
• Not conventional/classical mechanism<br />
• Potential novel mechanism for unmet needs<br />
IP Status<br />
• Long Patent Life (Filed in 2006, Issued in 2009 US 7,598,279)<br />
2
<strong>YKP3089</strong> Preclinical Profile<br />
Animal Model Profile<br />
• Anticonvulsant Profile<br />
‣ Broad spectrum activity in Rat & Mice (i.p., p.o.)<br />
• Pain Profile<br />
‣ Potent efficacy in Chung & Bennett models in Rat<br />
• Bipolar Profile<br />
‣ Potent efficacy in Hippocampal Kindling, Bipolar Mania models<br />
• Anxiolytic Profile<br />
‣ Active in diverse AX models in Rat & Mice (i.p., p.o.)<br />
3
<strong>YKP3089</strong> Clinical Profile<br />
Clinical Studies<br />
• Phase 1 Single Dose<br />
• Phase 1 Multiple Dose<br />
• Food Effect<br />
• Oral Contraceptive DDI<br />
• Mass Balance<br />
• Proof of Concept<br />
Photosensitivity Study<br />
Profile<br />
• Excellent PK Profile<br />
• Dose proportionality<br />
• Well tolerated<br />
• No Food effect<br />
• No Oral Contraceptive interaction<br />
• Good Mass Recovery<br />
• Proof of Concept correlation with<br />
Plasma levels<br />
4
<strong>YKP3089</strong> Clinical Timeline<br />
2010 2011 2012<br />
Additional DDI<br />
Phase 2 Epilepsy<br />
Phase 3 Epilepsy<br />
Neuropathic Pain<br />
Full Neuropathic Pain<br />
Bipolar Disorder<br />
5
<strong>YKP3089</strong> Development Challenges<br />
Challenges<br />
• Epilepsy Study Design and Execution<br />
‣ Sites: USA or Outside USA<br />
‣ Recruitment<br />
‣ Minimizing Placebo effect<br />
• Competing resource of additional indication development<br />
‣ Timely development<br />
• Unique and <strong>Novel</strong> mechanism<br />
Need Development Partner to facilitate pursuing 2 or 3 indications<br />
6
<strong>YKP3089</strong> Marketplace Opportunity<br />
Differentiation<br />
•<strong>Novel</strong> Mechanism albeit undefined offers fulfillment of current<br />
Unmet Needs<br />
• Potential therapeutic for Epilepsy with anxiety comorbidity<br />
• Better Compliance Once a day treatment<br />
• Increased tolerability<br />
• Expansion outside of Epilepsy –Neuropathic Pain, Bipolar and Anxiety<br />
• Excellent API Process developed –API Cost reduction expected (Patent Filed)<br />
7
•COFFEE BREAK
Change language