NA-831: a New Drug Candidate for Treatment of Alzheimer’s Disease Lloyd Tran CEO NeuroActiva, Inc. Confidential – do not distribute- March 14, 2018 1
NeuroActiva, Inc. is a bio-pharmaceutical company committed to discover, develop and commercialize new drugs to treat Alzheimer’s disease. Alzheimer's disease (AD) is a progressive disease of the brain that is characterized by impairment of memory and eventually by disturbances in reasoning, planning, language, and perception. Confidential – do not distribute- March 14, 2018 2
In the US, 5.3 million people has Alzheimer’s disease (AD) in 2016, the • number of victims will increase to 13.4 million by 2050. Worldwide the total AD patients will increase to a 100 million by 2050. • The cost of care in the US, currently at $216 billion in 2016. • Confidential – do not distribute- March 14, 2018 3
Jefferies analyst Michael Yee, estimated the sales of a new Alzheimer drug could peak sales of $2 billion to $4 billion per year, if the therapy wins regulatory approval. 4
Failure of AD drugs in Phase 3 over the past 10 years: Tarenflurbil (Myrial Genetics – 06/2008) • Semagacestat (Eli Lilly- 08/2010) • Bapineuzumab (Pfizer and Johnson & Johnson- 07/2012) • Solanezumab (Eli Lilly- 11/2016) • Verubecestat (Merck- 02/2017) • Intepirdine, (Axovant Sciences, 09/ 2017) • Amyloid hypothesis, proposed in 1984, postulates that accumulation of • amyloid plaques trigger a cascade that harms neurons and synapses. The above failed drugs targeting at Aβ pathology include decreasing of Aβ • production, preventing aggregation of, or stimulating clearance of Aβ . All immuno-therapy drugs based on β -secretase, γ -secretase, and • stimulators of α –secretase failed in Phase 3 trials. Confidential – do not distribute- March 14, 2018 5
AD is a complex multifactorial pathology, including multiple cycles and • sub-cycles of self-amplifying neurodegenerative process. Mono-therapy targeting single steps in this complicated cascade may • explain disappointments in trials. NeuroActiva’s strategy is to focus on novel multi-target therapy with • disease-related mechanisms, resulting in additive or synergic therapeutic responses Confidential – do not distribute- March 14, 2018 6
NeuroActiva has developed a new platform of new drug candidates for treatment of Alzheimer’s and other neurological diseases. Our guiding principle is based on proven clinical strategies of: 1 st strategy: NEUROPROTECTION: to protect the damaged neurons by • activating the neuronal defense system 2 nd strategy: NEUROGENESIS: to regenerate new neurons to activate the • neurotransmission pathway 3 rd strategy: ENHANCING COGNITIVE CAPACITY AND MEMORY • The combined strategies will restore the lost memory and to rebuild the • cognitive ability and mental functions. This will help stop and cure Alzheimer’s disease Confidential – do not distribute- March 14, 2018 7
Our research team has discovered a new drug, called NA-831: NA-831 exhibits neuroprotection • Effective at extremely low concentrations • Is an endogenous compound, already in existence in the brain • It is very safe , with no toxicity observed • Exhibits strong neurogenesis • NA-831 has been shown to enhance the cognitive and memory in • animal studies Confidential – do not distribute- March 14, 2018 8
Exposure of PC12 cells to NA-831 (10 μ M, 72 h) significantly (p = 0.025) reduced cell death caused by Aβ25–35 , increasing the cell viability to 230 ± 60.45% . Confidential – do not distribute- March 14, 2018 9
NA-831 decreases the tau phosphorylation induced by Аβ in PC12 cells. Western blot analysis and graphs showed the changes in the content of the phosphorylated tau (Ser396) in PC12 cells pre-treated with NA-831 Confidential – do not distribute- March 14, 2018 10
NA-831 promotes nerve cell regeneration at sub ventricular zone Confidential – do not distribute- March 14, 2018 11
Title: A Single-blind, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of NA-831 in Healthy Volunteers. Treatment: The study consisted of three cohorts, each having four dose- escalating sessions. Each cohort had 12 healthy volunteers. Each subject received placebo and up to three ascending doses of NA-831 in a randomized sequence on up to four separate study occasions. The evaluated doses over all the 4 cohorts were 2 mg, 5 mg, 10 mg and 20 mg, 50 mg in either the fasted or the fed condition. Summary of Results • Single dose of NA-831 of up to 50 mg were well tolerated. • No adverse event was reported. Confidential – do not distribute- March 14, 2018 12
NA-831 was found to have high efficacy in the treatment of 32 patients with mild cognitive impairment with marked improvement in 47.6% and significant improvements in 42.9%, a total of 90.5% in all patients in the clinical trial. 13
Ability to Concentrate and Count 3.0 ** Significant differences compared with baseline (p < 0.01) * * * 2.0 ** ** Day 21 Day 14 Day 1 Day 3 Day 7 Day 28 Day 42 Day 56 Confidential – do not distribute- March 14, 2018 14
Short Term Memory 3.0 * * * 2.0 ** ** Day 14 Day 21 Day 3 Day 7 Day 28 Day 56 Day 1 Day 42 Confidential – do not distribute- March 14, 2018 15
Long Term Memory 3.0 * * * 2.0 ** ** Day 21 Day 14 Day 3 Day 7 Day 28 Day 56 Day 1 Day 42 Confidential – do not distribute- March 14, 2018 16
NA-831 is designed as a disease modifying drug • – Increasing neuroprotection – Reverse existing neuronal damage Improve efficacy • – Not just cognition, but also memory and behavior Safe with little side effects, as it already exists in the brain • Administration: oral (one 10 mg capsule per day) • Confidential – do not distribute- March 14, 2018
Lloyd Tran CEO NeuroActiva, Inc. Tel. 415-941-3133 LTran@neuroactiva.com 18
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