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This graphical representation displays the ileum interior covered by intestinal villi. The enteroendocrine cells are shown in light blue colour. The 7TM receptors on the microvili are stimulated by fat and carbohydrate metabolites (displayed as yellow spheres and white cubes). Upon stimulation the enteroendocrine cell releases hormones to the blood vessel, i.e. ileal brake signalling.

The Science

The worldwide burden to obesity is estimated to 1.5 billion overweight and 500 million obese individuals, defined as a body mass index (BMI) of 30 kg/m2 or greater. In USA and in countries across Europe 30-70% of the population are overweight, with a BMI of 25-29.9 kg/m2. Overweight and obesity is the fifth leading risk for global deaths. Among the most troubling obesity-related trends has been the almost 50% increase of overweight children and adolescents in the last decades of the 20th century.

Despite this clearly identified serious health issues directly related to obesity on a global scale, there is not yet a sufficient tool-box of treatments available for physicians to reverse the obesity trends. The treatment alternatives for overweight and obese patients are obviously not fully successful when considering both efficacy and safety. Firstly, life style changes have low compliance and consequently poor long-term effects. Secondly, available oral medications have a limited efficacy (5-10% weight loss) and often associated with troublesome side-effects. Thirdly, bariatric surgery, is effective but irreversible, and may result in multiple severe adverse effects.

 

Empros Pharma address this unmet and strong medical need for a safe and effective medical product by developing EMP16, a novel oral and locally active medical treatment for overweight and obesity and related common metabolic disorders such as type-2 diabetes and non-alcoholic fatty liver disease (NAFLD). NAFLD is one of the causes of fatty liver, occurring when fat is deposited (steatosis) in the liver due to causes other than excessive alcohol use. NAFLD is the most common liver disorder in developed countries. NAFLD is related to insulin resistance and the metabolic syndrome and may respond to treatments originally developed for other insulin-resistant states (e.g. type-2 diabetes) and weight management. If not treated NAFLD may progress into liver cancer. Another common disease is polycystic ovary syndrome (PCOS) that might be successfully treated with EMP16 in the future. EMP16 entered clinical phase IIa during 2016 and the results will be reported during 2017. The objective is to develop a safe, highly tolerable oral local treatment that reduces body weight more than established therapy (>8-12%).

 

 

The main mechanism of action for EMP16 is to delay the normal food digestion and absorption processes to the end of the small intestine (see the graphical representation on top of this page). The main mechanism is local enzyme inhibition of various amylases and lipases responsible for carbohydrate and lipid digestion in the gastrointestinal tract. The gastrointestinal tract is an organ for enzyme mediated digestion and absorption of ingested food as well as it is largest endocrine (hormone secretion) organ in the body. Satiety is triggered by a complex interplay between hormones, nutrients and transmitter substances in the body. Digested food reaching the end of small intestine leads to an increased secretion of several gut hormones that act locally through receptor in specialized enteroendocrine cells on the motility of the gastrointestinal tract and on the brain centre regulating satiety. The gastric motility is regulated so that stomach emptying rate and food transit rate through the upper part of the gastrointestinal system slows down. This effect is commonly known as the ileal brake and is mediated by locally released gut hormones when digestion and absorption of free fatty acids and hexoses (i.e. glucose) act via specialized receptors in ileum. The shift on gastrointestinal digestion induced by EMP16 is expected to increase satiety by increasing the local hormone response, once the digested carbohydrates and lipids are absorbed by the intestinal enteroendocrine cells where these specific receptors are located. EMP16 acts locally in the gastrointestinal system through re-routing digestion and the exposure of natural dietary derived ligands (i.e. digested carbohydrates and lipids) to important satiety and eating behaviour regulating mechanisms.

 

 

EMP16 is based on a proprietary advanced drug delivery technology, designed to have features that optimizes its effect throughout the gastrointestinal tract. EMP16 is an oral product with a local effect in the gastrointestinal systems. It is a fixed dose combination of two locally active, safe and established active drugs. EMP16 is a multiple unit, modified release formulation designed to target the satiety regulation via the ileal brake mechanism. The advanced multiple unit, modified release formulation is designed to maximize the effect of the drugs as well as improving tolerability. The mechanism of action of EMP16 is based on supporting and increasing the natural satiety response present in the gastrointestinal systems to regulate food intake.

 

Distinct to other hormone based satiety regulating pharmaceuticals that act on one or a few of the hormone signalling pathways, EMP16 enhances the entire endogenous hormone response in a physiological way. Empros Pharma expects that this is a safer and more potent method to address the unmet medical need of obese patients.  The design of an advanced multiple unit and function oral dosage form is also expected to significantly reduce local side-effects and to increase tolerability.

The Team

Arvid

Dr. Arvid Söderhäll

Chief Executive Officer

Arvid has been engaged since the start-up of the company and CEO since 2015. He is a physicist and has a Ph.D.  in physical chemistry. He has been managing a wide range of scientific as well as strategic development projects for the more than 15 years, both as project manager and Principal Investigator. He has been working in academic research, biotech startup as well as high level policy making organisations.

Hans

Prof. Hans Lennernäs

Chief Scientific Officer

Hans is one of the founders of Empros Pharma AB and an inventor. Hans is a recognized serial inventor of more than 17 drug delivery patents and co-founder of several companies developing pharmaceutical products such as Abstral®, Plenadren® and Liproca Depot.  He has been Principal Investigator in ten years long collaborations with Food and Drug Administration (FDA, USA) as well as Medical Products Agency (MPA, Sweden). He is also one of the leader of an industrial consortium that is focused on several aspects of designing and developing oral drug delivery systems (www.orbitoproject.eu). He is full professor at Uppsala University with more than 190 well-cited publications.

Ulf

Dr. Ulf Holmbäck

Head of Clinical Program

Ulf is one of the founders of Empros Pharma AB and an inventor. He has a master in medical sciences and a PhD in nutrition. His areas of expertise are mainly nutrition physiology and circadian metabolism. Ulf has been involved in several pre-clinical as well as clinical trials. He holds also a position at Uppsala University.

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Stefan Grudén

Head of CMC and QA

Stefan is one of the inventors behind Empros. He is a pharmacist by education. He has 20 years of industrial experience in pharmaceutical development whereof 15 years in senior positions. He has been involved in 50+ pharmaceutical projects, whereof more than a third are marketed products.

Assoc. Prof. Anders Forslund, MD

Chief Medical Officer

Anders is one of the founders of Empros Pharma AB and an inventor. He is an expert in paediatric obesity at Uppsala University Hospital since 2008. His main focus is clinical and research on childhood obesity. In that work he saw the need for a safe and effective medicine that also could be used in obese adolescents. He is responsible for the clinical part as well as Principal Investigator of several EU projects.

Prof. Göran Alderborn

Scientific Advisor

Göran is one of the founders of Empros Pharma AB and an inventor. He holds the chair in pharmaceutical technology at Uppsala University and he has for many years held several academic leader positions at the same university. He is an internationally recognized expert on the technology and materials science of solid dosage forms with a research focus on the characterization and processing of particles and particle systems. He has published more than 100 original and review papers and is the author of several chapters on tablet formulation and manufacturing in international text books.

The Company

Empros Pharma AB is a private Swedish limited liability company located in Stockholm and Uppsala. The company was founded in late 2013 by researchers and entrepreneurs at Uppsala University together with the investor Flerie Invest. During 2014, establishing intellectual properties and company structure were main operational focus. During this year, regulatory strategy, intellectual properties strategy, development strategy and business strategy were developed. During 2015 the main focus was to develop the pharmaceutical formulation of EMP16 and continued IPR work. During 2016 Empros Pharma entered clinical phase.

The Board

Lars Martin

Chairman of the board

Lars is a senior manager in pharmaceutical industry for more than 30 years with sales and marketing positions at GlaxoSmithKline, MSD and Clinical Data Care. He has also been venture capital investment manager.

Dr. Carl-Johan Spak

Director of the board

Carl-Johan is Executive Vice President Global Technologies at Recipharm. He has 35 years experience in pharmaceutical industry with positions as managing director and  CEO in small startup companies as well as larger pharmaceutical companies. Carl-Johan has a PhD in dentistry and pharmacology.

Prof. Hans Lennernäs

Director of the board

Assoc. Prof. Anders Forslund, MD

Substitute Director of the Board

Dr. Ulf Holmbäck

Director of the board

Thomas Eldered

Substitute Director of the Board

CEO of Recipharm AB and owner of Flerie Invest.

CONTACT US

Arvid Söderhäll, CEO

CONTACT US

Arvid Söderhäll, CEO