1 / 9

2010 ASENT Conference March 2010

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

dara-conrad
Download Presentation

2010 ASENT Conference March 2010

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. 2010 ASENT Conference March 2010

  2. 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-2014

  3. Mechanism of Action Demonstrated molecular site of action, cellular activity, in vivo efficacy • 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

  4. Epilepsy Efficacy Data NTP-2014 has shown strong efficacy across multiple models • 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 CPS – Complex Partial Seizures

  5. Epilepsy Efficacy – Temporal Lobe Epilepsy Model NTP-2014 is more potent than existing therapies * p < 0.05 versus control 10 mice per treatment group Number of discharges not shown Comparators not run concurrently; historical data 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) CONFIDENTIAL

  6. Neuropathic & Nociceptive Pain Efficacy Data NTP-2014 has shown strong efficacy across multiple models • 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

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

  8. Oral Nociceptive Efficacy – Tail Flick NTP-2014 showed extremely robust efficacy after oral administration 8-10 mice per treatment group 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

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

More Related