2010 ASENT Conference March 2010. Highlights A novel mechanism of action and a new class of therapy in a large marketplace where existing mechanisms leave.

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Presentation transcript:

2010 ASENT Conference March 2010

Highlights A novel mechanism of action and a new class of therapy in a large marketplace where existing mechanisms leave substantial unmet need Multiple positive, predictive and highly significant efficacy studies in neuropathic pain, nociceptive pain and epilepsy Strong safety pharmacology profile and GLP toxicology results Experienced drug development team Strong IP position, including 2 issued and 28 filed patents covering novel mechanisms and composition of matter Target IND filing 2Q10 for lead compound, NTP

Mechanism of Action Novel mechanism of action – Enhances inhibition via a specific and unique action that is unlike that of any marketed product Highly specific activity generates strong efficacy without generating typical CNS side effects, such as sedation – Enables a greatly expanded and IP-rich pipeline using SAR via recombinant receptor technology and rapid screening via in vitro electrophysiology NTP’s molecules are new chemical entities (NCEs) – Novel composition of matter intellectual property 2 Demonstrated molecular site of action, cellular activity, in vivo efficacy

Epilepsy Efficacy Data 3 MES (Maximum ElectroShock) – Acute seizure model – Showed complete protection for the duration of the study (four hours) – No adverse events observed 6 Hz Psychomotor Seizure – Refractory epilepsy model (CPS) – Eliminated seizures in a “therapy resistant” epilepsy model where multiple blockbuster products have shown no efficacy – No adverse events observed MTLE (Mesial Temporal Lobe Epilepsy) – Refractory epilepsy model (CPS) – Showed near complete suppression of discharges, controlling seizures better than all other AEDs tested, including four blockbuster therapies – No adverse events observed NTP-2014 has shown strong efficacy across multiple models CPS – Complex Partial Seizures

4 NTP-2014 is more potent than existing therapies CONFIDENTIAL NTP-2014 showed near complete suppression of discharges and controlled seizures better than four blockbuster therapies: Depakote (valproic acid)Tegretol (carbamazepine) Lamictal (lamotrigine) Lyrica (pregabalin) Epilepsy Efficacy – Temporal Lobe Epilepsy Model * p < 0.05 versus control 10 mice per treatment group Number of discharges not shown Comparators not run concurrently; historical data

Neuropathic & Nociceptive Pain Efficacy Data 5 Formalin Paw – Neuropathic & Nociceptive Pain – Late Phase: Showed near 100% pain reduction; results superior to gabapentin – Early Phase: Demonstrated pain reduction, where gabapentin is ineffective – No adverse effects reported Chemotherapy Induced Peripheral Neuropathy – Neuropathic Pain – Demonstrated 100% reversal of pain – No significant adverse effects observed Chung – Neuropathic Pain – Exhibited rapid and significant reduction in pain – No significant adverse effects observed Tail Flick – Nociceptive Pain – Showed rapid and dramatic reduction in pain; similar to the effect of high dose morphine – Onset of pain relief occurs within ten minutes of oral dose and extends for a long duration – No significant adverse effects observed with 2014; significant adverse effects with morphine NTP-2014 has shown strong efficacy across multiple models

Neuropathic Pain Efficacy – Chemo-induced PN 6 NTP-2014 demonstrated the maximum pain relief possible in this model In a Taxol-induced model of neuropathy, NTP-2014 completely reversed chemotherapy-induced pain at a lower equimolar dose than gabapentin. CONFIDENTIAL Nine rats per treatment group

Oral Nociceptive Efficacy – Tail Flick 7 NTP-2014 showed extremely robust efficacy after oral administration When administered orally, NTP-2014 exhibits a highly significant reduction in pain. Further, such protection occurs within ten minutes of dosing and extends for a longer duration than after IP administration. This creates an exciting opportunity for a highly effective, fast acting, non-opiate therapy for acute pain. CONFIDENTIAL 8-10 mice per treatment group

Development Timeline 8 IND Creation (2014) Ph I SD (2014) Ph I MD (2014) Phase IIa - Neuropathic Pain (2014) Phase IIa - Acute Nociceptive Pain (2014) Phase IIa – Epilepsy (2014) Dec 2009Dec 2010Dec 2011Dec 2012 Form / CMC (2014) Early Signal (2014) NTP plans to initiate human clinical trials in 2Q10 NTP’s development plan will reduce risk and be highly capital efficient through use of multiple Phase IIa proof-of-concept studies. Platform Development Ph I SD (2 nd Cmp) Ph I MD (2 nd Cmpnd) IND Creation (2 nd Cmpnd) Efficacy, PK, Toxicology, Form / CMC (2 nd Compound)