MONTCLAIR, N.J., September 27, 2016 /PRNewswire/ -- Nexus BioPharma, Inc., (OTC-BB NEXS), a company specializing in the development of a weight loss drug therapy, today provided a business overview to outline the clinical status of its flagship weight loss product candidate currently in pre-clinical development for the treatment of obesity, and an overview of near-term corporate, business, clinical and regulatory milestones expected through 2017.
"We have achieved notable progress this year on corporate, clinical and regulatory fronts, and I believe we are now rapidly heading into the most exciting time for Nexus BioPharma to date," said Warren C. Lau, Chief Executive Officer of Nexus BioPharma.
Recent Corporate Highlights
- Presented a poster in collaboration with Charles River Laboratories BioFocus at the Royal Society of Chemistry’s “Kinase 2016: Next Generation Inhibitors” conference in Nottingham, UK. The poster entitled “Discovery of FYN inhibitors using the SoftFocus® screening library” described the discovery and development of small molecules targeting FYN kinase for a new approach to the treatment of obesity.
- Appointed Jeffrey Pessin, Ph.D. as Chairman of the Company's Scientific & Clinical Advisory Board. Dr. Pessin is the Judy R. & Alfred A. Rosenberg Professorial Chair in Diabetes Research and Director of the Diabetes Research Center, Department of Medicine at the Albert Einstein College of Medicine. He also serves as Professor in the Departments of MedicineMolecular Pharmacology.
- Appointed Daniel Einhorn, M.D. to the Company’s Scientific & Clinical Advisory Board. Dr. Einhorn is medical director of the Scripps Whittier Diabetes Institute, clinical professor of medicine (voluntary) at UC San Diego, president of Diabetes and Endocrine Associates, and associate editor of the Journal of Diabetes.
- Appointed ofHelen Stefanovic as Director of Regulatory Affairs. She was previouslyManager, Science Policy, Corporate Strategic Planning and Policy at Pfizer Inc, World Headquarters.
- Filed a New International Patent Application (PCT/US2016/050776) entitled “Methods, Compositions, and Uses of Novel FYN Kinase Inhibitors”. The application covers composition of matter and methods of use for specific compounds in a number of chemical structure families for the treatment of a variety of conditions including weight loss, symptoms of type 2 diabetes, neurodegenerative disease including Alzheimer’s Disease, and the symptoms of ageing.
- Put in place a funding arrangement for up to two million dollars at the currently prevailing market price with a European institutional investor.
"These achievements were transformational for Nexus BioPharma. The Company is fundamentally stronger than it ever has been, and we are positioned to strategically expand our pipeline of opportunities in the future," stated Mr. Lau.
Mr. Lau added, "The key appointments of our Director of Regulatory Affairs, Helen Stefanovic, as well as the highly regarded Drs. Pessin and Einhorn to our Scientific & Clinical Advisory Board, position Nexus BioPharma at the forefront in the development of a new generation of safer and orally available weight loss therapeutics. Leveraging the strength and expertise of our expanded team will prove to be an integral factor in unlocking and building shareholder value, in both the short-term and long-term."
Nexus’ compounds for the Treatment of Obesity – Clinical Development Overview
The Company also provided an update to its corporate progress and clinical status for its new generation, orally available weight loss therapeutic. Our mechanism of action is fundamentally differentiated from all FDA-approved weight loss drugs, with potential to drive a paradigm shift towards new generation safer and faster-acting weight loss drugs. Nexus BioPharma's development strategy is focused on establishing it as the primary option for overweight and obese individuals with inadequate response to standard, currently available prescription drugs, displacing them in the current obesity treatment paradigm. Nexus BioPharma expects to complete its pre-IND studies by the end of 2017.
Pipeline Expansion Opportunities
Nexus BioPharma aims to expand its compounds into multiple additional indications beyond treatment of obesity -- to include treating symptoms of type 2 diabetes, neurodegenerative disease including Alzheimer’s Disease, and ageing -- each representing potential blockbuster opportunities.
Nexus is also evaluating opportunities to acquire or license synergistic obesity product candidates to expand its pipeline.
Near-Term Milestones Expected to Drive Value
- Meet with FDA for Preliminary Investigational New Drug application (Pre-IND) regarding Phase I study of weight loss compound as treatment for obesity in Q4 2016-Q12017;
- Commence study of a selection of compounds as a treatment for Alzheimer’s Disease (AD) in Q1 2017. Published studies (FYN Inhibition Rescues Established Memory and Synapse Loss in Alzheimer Mice, Annals of Neurology 2015; Jun;77(6):953-71; Adam C. Kaufman, et al) have shown that inhibition of FYN kinase in an animal model of AD can restore memories and increase synaptic density;
- Plan with FDA the company’s application for Fast Track Designation for weight loss drug as a treatment for Prader Willi Syndrome in Q3 2017; and
- Meet the requirements and apply for full NASDAQ listing in Q2-3 2017.
"We fully intend to build upon the significant momentum we have created this year and will continue to focus on operational excellence as we drive our compounds towards clinical development and commercialization. We believe our weight loss therapeutic has the potential to be a game-changing therapy for individuals living with obesity where there remain significant shortcomings in current treatment alternatives, and we are committed to advancing our development programs in additional indications such as Alzheimer’s Disease as rapidly as possible. Our weight loss drug will have an important role in the global weight loss market," Mr. Lau concluded.
About Nexus BioPharma www.nexusbiopharma.com
Nexus BioPharma, Inc. is developing a revolutionary new weight loss drug that works by adjusting the body’s metabolism to increase the burning of fat by activating the AMPK metabolic pathway, the same pathway activated by intense physical exercise.
The underlying biochemistry was described in an article in the journal Cell Metabolism by Claire C. Bastie, and Jeffrey E. Pessin, entitled "FYN-Dependent Regulation of Energy Expenditure and Body Weight Is Mediated by Tyrosine Phosphorylation of LKB1". Cell Metab. 2010 Feb 3;11(2):113-24
In completed pre-clinical trials of the pharmaceutical activation of this pathway, test subjects showed reduced fat mass with no loss of lean muscle mass, plus a higher rate of energy expenditure, increased insulin sensitivity, increased fatty acid oxidation, improved plasma and tissue triglyceride levels, with lower cholesterol. Upon translation of this pharmaceutical activation to humans, these effects are expected to have a significant impact on obesity and diabetes.
Using the most advanced high throughput screening technology, Nexus BioPharma has identified small molecule compounds in a number of discrete chemical structure families that can efficiently activate the pathway. The Company has filed for intellectual property protection on a selection of compounds in a number of discrete chemical backbones. The Company's goal is to advance to pre-IND trials in preparation for FDA human trials of a drug that will safely mimic this effect in humans.
Cautionary Statement Regarding Forward-Looking Information
This press release may contain certain "forward-looking statements" relating to the business of Nexus BioPharma, and its subsidiary companies. All statements, other than statements of historical fact included herein are "forward-looking statements" including statements regarding: the impact of the proceeds from the private placement on the Company's short term business and operations,; the general ability of the Company to achieve its commercial objectives, including the ability of the Company to sustain growth; the business strategy, plans and objectives of the Company and its subsidiaries; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.