NapticBio is passionately committed to develop therapies that improve outcomes for patients with Alzheimer’s and other neurodegenerative disorders.
We have conducted pre-clinical trials funded by NIH using a combination of Δ9-THC and a COX-2 inhibitor and currently preparing for a successful IND and Phase I human trials to develop a treatment backed by patents on combination therapy and composition, methods of use and treatment.
Our objective is to leverage the existing regulatory approval of drugs, partner with pharma or other entities to help speed our product to market for patients with mild cognitive impairment and early stage Alzheimer’s.
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.
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.
Repeated Δ9-THC exposure contributes to impairments in long-term synaptic plasticity & cognitive function due to elevation of COX-2 expression & activity. These Δ9-THC induced impairments can be mediated by utilizing a COX-2 inhibitor.
COX2 reduces the inflammation and neuron degeneration caused by THC, thus allowing prolonged THC use without cognitive impairment.
Δ9-THC has the potential to stimulate appetite and aide in weight control, motor function and potentially reduce agitation.
Broad Utility Patents covering combination therapy licensed from LSU (US Patent No: US 9,763,912 B; US Patent No: 9,833,433 – Compositions, Methods Of Use, And Methods Of Treatment)
Next Steps: Complete Preclinical studies for oral dosing and apply for Fast Track designation for FDA approval.
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
Nick Poulios, PhD, PhM
CEO – responsible for setting company direction-corporate strategy, market access, corporate partnerships.
Dr. Poulios 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, Dr. Poulios 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. Dr. Poulios 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
Benjamin Hoehn, MD, PhD
Advisor Medical Affairs – responsible for helping NapticBio develop with 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.
Dr. Hoehn has strong back ground in working in biotech industry and academia. He spent the last 5 years working for Johnson and Johnson in regional and global roles. He was most recently Chief Medical Officer for Codman Neurosurgery, a $700M franchise in Johnson and Johnson Medical. He sat on the Codman Board of directors as well as the Johnson and Johnson Medical affairs Leadership Board. He was responsible for running the global medical affairs department for business acquisition of new technology for the portfolio. He has significant experience in dealing with the FDA in new product application, CTA, ISE, ISS, 510k, etc. He has previously worked extensively in Asia for Johnson and Johnson Medical Device sector as their North Asia Medical, clinical and Safety Director. Before joining J&J he worked for Genomictree, a diagnostics company where he was key in their success in developing a blood-based screening kit for colorectal cancer that is now approved by the Korean government and is the only kit of its kind on in the market in South Korea. Dr. Hoehn spent two years in Neurosurgery residency at University of Virginia, a position he held after completing his neuroscience MD and PhD at Stanford University.
Alexander Zubkov, MD, PhD
Advisor Medical Strategy – responsible for NapticBio 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.
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.