ABOUT US

NapticBio is passionately committed to develop therapies that improve outcomes for patients with Alzheimer’s and other neurodegenerative disorders.

We are currently conducting phase II pre-clinical studies using a combination of Δ9-THC and a COX-2 molecule and our goal is to develop a treatment for early Alzheimer’s with the following desirable properties: 1) good safety profile: both molecules have excellent records of safety in broad populations, and 2) both are already FDA approved in oral form.

Our objective is to leverage the existing regulatory approval of drugs, partner with pharma or other entities to help speed our product to market. Our current studies focus on patients with mild cognitive impairment and early stage Alzheimer’s.

THERAPEUTIC FOCUS

Today, few Alzheimer’s therapies are effective, and most have adverse side effect profiles. The last significant approval of an Alzheimer’s drug was in 2003 (Memantine). Despite massive efforts by the bio-pharmaceutical industry, there have been no breakthrough drugs to reach the market mainly due to their lack of efficacy and ability to treat the root cause.

The burden and cost of Alzheimer’s continues to grow, by 2050 it is predicted there will be around 13 million Americans with Alzheimer’s, up from 5.3 million today, and the cost to treat these patients will reach and unmanageable $1 trillion, up from $200 billion today. Worldwide, the number of patients will more than double by 2050 to 100 million.

Our mission is to bring a therapy that can slow down or reverse disease progression.

RESEARCH

NapticBio Alzheimer’s therapy combines two approved molecules that work synergistically to improve the outcome of mice genetically modified to express beta amyloid proteins, thought to be a key contributor to the progression of Alzheimer’s disease. Δ9-THC, as well COX-2 are FDA approved. We have completed proof of concept pre-clinical study funded by the NIH and are preparing follow-up studies that will help us start the IND application process.

Δ9-THC Slows Buildup of Neural Plaques; this toxic aggregation of peptides in the neural tissue is one of the characterizing pathological markers of Alzheimer’s.


Δ9-THC Could Prevent Cell Death through it’s neuroprotective, anti-oxidative, and anti-apoptotic properties, thus reducing neurotoxicity caused by amyloid buildup.


Δ9-THC has the potential in Alzheimer’s patients to stimulate appetite, and aide in weight control, motor function and potentially reduce agitation.

ABOUT US

Broad Utility Patents covering combination therapy licensed from LSU (US Patent No: US 9,763,912 B; US Patent Pending No: 15/672,817) Next Steps: Complete Preclinical studies for oral dosing and apply for Fast Track designation for FDA approval.

SCIENTIFIC DATA

Our pre-clinical findings were published in Cell:“D9-THC-Caused Synaptic and Memory Impairments Are Mediated
through COX-2 Signaling”;
Chu Chen, et al: Cell 155, 1154–1165, November 21, 2013

A chronic low dose of 9-tetrahydrocannabinol (THC) restores cognitive function in old mice:
Andras Bilkei-Gorzo, et al: Nature Medicine, VOLUME 23 | NUMBER 6 | JUNE 2017, pp 782-787

The Burden of Neurological Disease in the United States: A Summary Report and Call to Action: Annals of Neurology,
2017, pp 479-484

Alzheimer’s disease drug development pipeline:
2017: J. Cummings et al. / Alzheimer’s & Dementia: Translational Research & Clinical Interventions 3 (2017) 367-384

OUR TEAM

Nick Poulios, PhD, PhM

CEO – responsible for setting company direction-corporate strategy, market access, corporate partnerships.

Nick is a seasoned life sciences executive with over 25 years of increasing responsibility and achievements in the pharmaceutical and diagnostics industries in the areas of corporate value, market access, strategic pricing, public policy and business development.

Prior to joining NapticBio, Nick founded and lead several global corporate & market access functions for Roche Pharma, Baxter Bioscience, Elan Pharma, as well as diagnostics companies such as Gen-Probe and Roche Molecular Diagnostics. Nick is a frequent speaker at scientific and professional conferences and has over 40 publications on health outcomes research, budget impact, cost-effectiveness, quality of life, productivity, strategic pricing and reimbursement in peer review journals, such as: ATS, Blood, BSH, BJ Hematology, WFH, ISTH, Pharmacoeconomics, ISPOR, ASLD, AMCP, etc.

Dr. Poulios holds PhD, PhM degrees from the City University Of New York; MA from Virginia Commonwealth University/Medical College of Virginia and BA from the University of Richmond, Virginia. Dr. Poulios received post doc training at the Harvard School of Public Health, Department of Biostatistics.

George Simeon, MBA, MPH

VP – Investor Relations, has over 25 years of experience in the healthcare sector working with multinational firms, start-ups and not-for-profits. He has worked in pharmaceuticals, medical devices, IVD, and healthcare convergence technologies.

In 2014, he went to South Korea to work with SK Telecom’s Healthcare Division in M&A and global strategic alliances. Since then, he has been involved in a number of cross-border transactions and advised large firms and start-ups on global business strategy and fundraising. Before coming to Korea, he worked across Europe and the USA as an executive with Johnson & Johnson as Vice-President for Cordis Neurovascular Europe and with GHX Europe as a commercial Vice-President. He also spent 3 years with Novartis Global Headquarters in Switzerland working on projects in their CNS portfolio in Health Economics and Pricing. He has also founded two start-ups and advised GS1 on their global entry and expansion into the Healthcare sector.

George is a graduate of INSEAD (MBA), Yale University (MPH), Bocconi (PhD ABD) and the University of Ottawa (Economics).

Benjamin Hoehn, MD, PhD

Advisor Medical Affairs – responsible for helping NapticBio develop their medical affairs and clinical programs strategy. He is also assisting NapticBio pursue a series of IND’s, and Phase I-III Clinical trials for FDA as well as planning for post-market surveillance.

In 2010, Benjamin left the Neurosurgery clinics of UVA to start his career in the biotech sector by first doing a fellowship in the Department of neurosurgery at Dongguk University in South Korea. From there he entered industry when he started working for the startup diagnostic company Genomictree targeting blood based rapid testing for colon, lung and bladder cancer. He also was a consultant for Pongyo based pharma company, Crystal Genomics. He helped them develp strategy around a recently developed a first in class COX-2 inhibitor that they wanted to launch in the US market. He then transitioned to Johnson & Johnson Medical where he led their North Asia, Medical affairs, Clinical, and Safety organizations for their medical device sector. In this role he covered Korea, Hong Kong, and Taiwan. He continued to expand his department into Asia Pacific before moving to the Global role as CMO of Codman Neuro. His Academic and Professional experience spans multiple industries and regions of the world. In Asia he has developed and maintained strong relationships with leaders that understand the importance of building a stronger future in healthcare. He has and continues to make important contributions to the rapidly expanding fields of neuroscience, neurosurgery, and healthcare.

Dr. Hoehn has an MD and PhD degrees in Neuroscience from Stanford University.

Alexander Zubkov, MD, PhD

Advisor Medical Strategy – responsible for NapticBio medical affairs and clinical programs strategy and making sure NapticBio pursues a series of successful IND’s, and Phase I-III Clinical trials for FDA approvals through to post-market surveillance.

Dr. Alexander Zubkov is a very experienced neurologist who received initial neurosurgical training in Russia, followed by PhD in Physiology and neurology residency at the University of Mississippi Medical Center.

Subsequently, Dr. Zubkov completed his training in Mayo Clinic, Rochester, MN, specializing in stroke and neurocritical care. Dr. Zubkov has a large practice covering all areas of neurology, including headaches, dementia and of course vascular neurology. He published over 60 peer-reviewed papers and participated in multiple studies. His current practice is in Minneapolis Clinic of Neurology in Edina, MN.

Anastassios D. Retzios, Ph.D.

Advisor Regulatory Affairs – Founder and President of Bay Clinical R&D Services, Anastassios has extensive experience in clinical operations and pharmaceutical development. In his early career, in an academia/industry collaborative environment, he participated in the discovery and development of biologic therapeutic agents; later, he served in a variety of leading roles in the industry: as a Clinical Project Manager and Associate Director of Clinical R&D at Alpha Therapeutic Corporation; Senior Director of Clinical R&D at Questcor Pharmaceuticals; Global Director of Clinical Development at Baxter and Vice President of Clinical Development at AP Pharma, Inc.

Company Objective:

Focus on patients with mild cognitive impairment (MCI) and early stage Alzheimer’s. Leverage existing regulatory approval of drugs, partner with pharma or other entities to help speed our product to market.

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