NEUROFIX S MISSION & VISION
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2 NEUROFIX S MISSION & VISION MISSION Neurofix aims to discover and develop innovative therapies for the treatment of neurological disorders. Our main focus now is Spinal Cord Injury. VISION Spinal Cord Injury (SCI) is a condition with important unmet clinical needs and constitutes a huge market with very high sales potential and growth rate. Potent and safe first-inclass products for the treatment of neuropathic pain (NFX88) and paralysis (NFX81) in SCI patients pose Neurofix at a leading therapeutic position that may translate into huge revenues.
3 What Spinal Cord Injury is?
4 Causes of Spinal Cord Injury
5 Incidence: New cases per year. Prevalence: People currently affected SCI Market in the USA
6 Clinical Needs in SCI patients (90%) (81%) NFX81 NFX88
7 Current drug treatments against SCI NFX81 NFX88
8 SCI Pain: Unmet clinical need mm mm
9 SCI: Survival and cost of treatment
10 Neurofix Pipeline DRUG INDICATION I+D Preclinical Phase I Phase II Phase III NFX88 NFX81 NFX204 NFX91 Neuropathic pain (SCI) Paralysis (SCI) CNS Inflammation Sleep disorders
11 NFX88 against neuropathic pain Neuropathic pain is the worst symptom suffered by SCI patients. 11
12 PAIN TYPES Neuropathic pain is the worst symptom suffered by SCI patients.
13 USA market ca. $2b Neuropathic Pain Global Market
14 Market Projections for the 7MM Nature Reviews in Drug Discovery, 2012 Neuropathic pain is the worst symptom suffered by SCI patients.
15 GLOBAL NEUROPATHY MARKET mm mm
16 GLOBAL NEUROPATHIC PAIN MARKET
17 Neuropathic Pain Market: Beyond SCI
18 PREVALENCE, SOCIAL COST AND POTENTIAL SALES mm mm
19 Neuropathic pain players Company Pfizer Pfizer Depomed Eli Lily GlaxoSmithKline Bigen Product Lyrica (Pregabalin) PainDETECT Neurotonin (Gabapentine) Lazanda (fentanyl) Zipsor (diclofenac) CYMBALTA (duloxetine) Horizant (phase II) CNV (raxatrigine)
20 PAIN MANAGEMENT PLAYERS
21 PAIN MANAGEMENT PLAYERS Major Key Players Pfizer Depomed Eli Lily GlaxoSmithKline Bristol-Myers Squibb Sanofi J&J Baxter Healthcare Corporation Biogen Merck Cephalon
22 Anticonvulsant sales by indication Drugs currently used to treat neuropathic pain are usually pursposed for other conditions
23 COST OF TREATMENT In the EU the cost of treatment was calculated as an average from prices in the UK, Germany, France, Italy and Spain
24 DESCRIPTION Neuropathic pain is caused by damage or disease affecting the somatosensory nervous system. It may be associated with abnormal sensations (dysesthesia) or pain from normally non-painful stimuli (allodynia, hyperalgesia). It may have continuous and/or episodic components (like stabbings or electric shocks). Common qualities include burning or coldness, "pins and needles" sensations, numbness and itching. CURRENT SITUATION El NFX88 is orally administered and demonstrated its safety in phase I clinical trials and has shown efficacy in models of spinal cord injury. Next step is a phase IIA trial against neuropathic pain in patients with spinal cord injury. PROJECTION NFX88 will be developed as an orphan drug against neuropathic pain in patients with spinal cord injury. This strategy will allow quick develpment of this compound. Beyond spinal cord injury, neuropathic pain affects ca. 3% of the population. POTENTIAL MARKET NFX88 AGAINST NEUROPATHIC PAIN Approximately 82% spinal cord injury patients have neuropathic pain. In addition, over 20 million people in the EU may also suffer neuropathic pain. Currently, neuropathic pain is treated with anti-anxiolytic, anti-depressants, anti-convulsants, etc., which have limited efficacy and high toxicity. NFX88, specifically addressed against neuropathic pain, could become the reference drug in this field.
25 NFX88 for Neuropathic Pain A Large and Underserved Market 1. Neuropathic pain affects >3% of the population. 2. The total market reached $5B by 2010 in the US only and $5.3B by 2008 in Europe. 3. Worldwide the neuropathic pain market is > $10B and underserved, which makes it very attractive. 2. Neuropathic Pain has a unique etiology and doesn t respond to conventional analgesics, hence the interest in finding new therapeutic options.
26 NFX88 Electrophysiology Saline NFX80 NFX88 10xNFX80
27 NFX88 is better than pregabalin Veh (p.o.) Sham Veh (p.o.) SCI Preg (p.o.) SCI NFX88 (p.o.) SCI Oral NFX88 against pain: Inhibition of the withdrawal reflex induced by acetone in SCI rats. Animals were treated with vehicle (Veh), pregabalin (Preg) or NFX88 (p.o.). 27
28 Modulation of nociception with NFX88 The Spared Nerve Injury model von Frey Test and noxious heat reflex Vehicle NFX88 Vehicle NFX88
29 Modulation of nociception with NFX88 The Spared Nerve Injury model. Hot Plate Test LPA181 + SNI Vehicle NFX88
30 Modulation of nociception with NFX88 The Spared Nerve Injury model. Cold Plate Test Vehicle NFX88 LPA181 + SNI
31 MECHANISM OF ACTION Prostaglandin E 2 Synthase, Phospholipase A1 y Phospholipase A2 expression inhibition
32 Effect of NFX88 on PKA GPCR G protein AC PKA Neurofix S.L. 32
33 Effect of NFX88 on Rho kinase Neurofix S.L. 33
34 NFX88 on microglial reactivity Neurofix S.L. 34
35 Open-field anxiety test (SNI rats) Neurofix S.L. 35
36 Side effects for SCI pain treatment drugs Side effects for NFX88: None* Based on the expected therapeutic dose of grams/day and the data obtained in a phase I trial
37 NFX88 NFX88 Inhibitor of Inflammation mediator synthesis: PLA1 PLA2 PTGES NEUROFIX
38 NFX81 against paralysis in SCI patients 38
39 NFX81 AGAINST SCI PARALYSIS DESCRIPTION NFX81 was designed for the treatment of paralysis in patients with moderate spinal cord injury (SCI). Moderate SCI affects about 70% medular lesion patients. CURRENT SITUATION NFX81 has completed most regulatory toxiclogy preclinical studies. This compound is expected to start a phase I/II study in patients with SCI in PROJECTION SCI is an orphan condition that can benefit from accelerated regulatory processes and reduced regulatory fees. In addition, orphan drugs are given 10 years of market exclusivity in the EU and 7 years in the US regardless the intellectual property status. Currently, there are no treatments available against SCI-derived paralysis. POTENTIAL MARKET Spinal cord injury has a prevalence of ca. 3/10,000 in the EU. Approximately two thirds of them could benefit from NFX81.
40 NFX81 Mechanism of Action Precedents: Albumin-Oleic Acid, a Neurotrophic Growth Factor
41 SPINAL CORD INJURY VEHICLE TREATMENT DAY 1 DAY 7
42 SPINAL CORD INJURY NFX81 TREATMENT DAY 1 DAY 7
43 Effect of NFX81 against paralysis in SCI rats Vehicle NFX80 LPA181 NFX81
44 NFX81 MoA: Microarray analysis 44
45 NFX81 MoA: Gene Expression Neurofix S.L. 45
46 INVEST IN NEUROFIX 46
47 INVESTMENT OPPORTUNITIES Neurofix seeks for equity investment to complete a phase 2 for NFX88, start phase 1 for NFX81 and move forward its pipeline. For this purpose, Neurofix aims to raise 15-20m before January of 2019.
48 INVESTMENT OPPORTUNITY Neurofix has completed a 3-month pilot study in 5 pacients with neuropathic cancer pain with a good or very good response in 3 of them and no side effects Neurofix has a market value of a phase 1-company and a real value of a phase 2-company.
49 Phase 2a Clinical Trial 49
50 PHASE 2A TRIAL WITH NFX88 NEUROPATHIC PAIN TREATMENT IN PATIENTS WITH SPINAL CORD INJURY Multicentric study (3-4 hospitals) Double blind placebo vs verum Pregabalin plus 0 mg, 750 mg, mg y mg daily, p.o., 3 months Fifteen-patient groups (60 patients in total) Key Opinion Leaders Validated pain tests Primary endpoints: efficacy and safety Secondary endpoints: mechanism of action, biomarkers
51 PHASE 2B TRIAL WITH NFX88 NEUROPATHIC PAIN TREATMENT IN PATIENTS WITH SPINAL CORD INJURY To be defined on the basis of (1) phase 2A data, (2) negotiation with the EMA about orphan drug status and conditional approval.
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