Neurotez, Inc.
A biotechnology development company
Monday, June 13, 2016
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Neurotez, Inc. is a Delaware corporation with its corporate headquarters located in Bridgewater, New Jersey. The company aims to become a world leader in biotechnology, utilizing an integrated platform from discovery to proof of concept clinical trials leading to commercialization of Central Nervous System (CNS) drugs that are both safe and efficacious. The Company uses biochemical, molecular & cell biology and in vivo models to screen, identify and characterize suitable candidate biopharmaceuticals targeting major CNS disorders with unmet medical need.
It’s primary drug candidate is a recombinant human Leptin product (MEMTIN) used as a hormone replacement therapy for Alzheimer's disease ("AD"), and as a preventative for those who are at risk, repurposing a drug approved by the FDA for generalized lipodystrophy. This program derived from Neurotez’s efforts in the identification and characterization of factors relevant to obesity and/or the metabolic syndrome that modulate brain aging or the conversion of normal brain aging to that hampered with AD.
This type of strategy – in which a missing or deficient hormone is augmented via a human version obtained by recombinant DNA technology – has proven over time to be one of the lowest risk and most successful of all biotherapeutic approaches, as illustrated in the commercial histories of products such as recombinant insulin, erythropoietin, and human growth hormone.
Leptin, a naturally occurring human hormone associated with various metabolic effects, has a large number of receptors in memory centers of the brain. This protein is often present at decreased levels in patients suffering from Alzheimer’s disease, and cognitive deterioration in AD patients correlates strongly with a decline in circulating Leptin levels. Leptin replacement therapy represents a relatively de-risked drug development approach because:
- Multiple animal studies demonstrate Leptin’s ability to improve cognitive performance, including memory. The Company’s studies show that this effect is accompanied by a decrease in levels of both phospho-tau/tau and beta amyloid (Aβ), two of the key factors in Alzheimer’s disease etiology. Consequently, Leptin represents a highly attractive, multi-functional therapeutic approach.
- Recombinant Leptin has been successfully manufactured and mostly safely administered for over 12 months at therapeutically relevant doses for clinical trials on over 1,000 patients for other indications (obesity, lipodystrophy, hypothalamic amenorrhea).
- Leptin naturally crosses the blood-brain barrier, and clinical studies in six patients have shown that subcutaneous Leptin administration resulted in biologically relevant Leptin level increases in the brain.
- A study on three adults showed that 18 months of Leptin treatments resulted in an increase of gray matter tissue.
- In separate work, Leptin treatment improved cognitive development of a congenital Leptin-deficient individual and improved memory performance in HIV infected patients.
To date, Neurotez has raised approximately $4.5MM, including a $2.7MM Phase II and a $0.8MM Phase I SBIR grant from the National Institutes of Health. These funds have been directed toward mechanism of action studies, intellectual property, manufacturing of a clinical-grade Leptin product, leading to currently planned IND-enabling studies. We anticipate the need of another $4MM to file an IND application using our own biologic as the API. The Single Ascending Dose ("SAD") and Multiple Ascending Dose (MAD) phase 1 studies will incorporate a small group of MCIs to be treated for 28 days and evaluated for CSF biomarker changes ($4.2MM). This will be followed by a phase II clinical trial ($29MM).
Neurotez also has two additional products in the discovery stage as well as novel screening technologies and a simple genetic test for TOMM40 variants, providing the foundation for the expansion of its portfolio and licensing and partnering opportunities. The screening technologies can provide additional pipeline products and easily adapted to repurpose drug candidates at all stages of development, including approved drugs for other indications. Neurotez intends to explore these and other opportunities as soon as capital becomes available.
The Company is raising funds to support the clinical development of the Company’s own recombinant Leptin product (Memtin), leveraging existing data from preclinical studies, along with extensive data from clinical trials targeting other therapeutic indications. In particular, while the use of Leptin has been approved for generalized lipodystrophy and extensive clinical trials for obesity have provided ample of safety data for Leptin, Neurotez’s array of patents/patent applications should effectively deter competition until 2029 and beyond.
3 Major Issues
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- Regulatory: Neurotez intends to develop its own Leptin product (Memtin) initially for an enriched subgroup of prodromal Alzheimer’s cases. Depending on how stringent the criteria we implement are, this group can be adjusted to target less than 200,000 cases in the US. Effectively this becomes the size of an orphan drug indication. Can we have orphan drug designation with a subgroup of a common disease? How would that impact our interactions with the FDA and payers ?
- Competitive Positioning: In the US, Biologics Act provides 12 years of market exclusivity for a brand new biologic (similar provisions exist in other major markets). If Neurotez develops its own biologic it would aim to take advantage of the provision. How different does it have to be compared to MYALEPT (amino acid sequence, potency, post translational modifications, formulation)? Can Aegerion, the owner of MYALEPT block our efforts (through Biologics Act, Orphan Drug exclusivity)? What developers of biosimilars can be a problem for Neurotez if the MYALET and Memtin are very similar, as MYALEPT’s exclusivity will be running out sooner (2026).
- Strategic Marketing: Should we get Memtin approval outside the US first? Which markets are the best candidates for such a strategy?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Nikolaos Tezapsidis PhD, President and CEO of Neurotez, will deliver the Company's "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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 Slides
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