This novel program demonstrated the safety and efficacy of Stablor(R) for pre-diabetic and obese patients living with abdominal obesity and co-morbidities
Bordeaux, France, June 25, 2014, - LNC (Laboratoires Nutrition et Cardiometabolisme), a research and development company specialized in the treatment of chronic metabolic diseases, today announces the end of its ten-year Obeminale program.
The Obeminale program began in 2004 and incorporated fundamental research, clinical and behavioral trials. It also compiled real life data from 5,000 patients with abdominal obesity and co-morbidities who used Stablor.
Obesity has become a major global health challenge, according to the Lancet (1). No national success stories in the fight against obesity have been reported in the past 33 years. Health authorities and big pharma are looking for ways to address this complex issue by incorporating physiopathology and behavioral changes.
LNC is a pioneer in the characterization of bioactive peptides that affect diabetes and obesity. LNC targets the root cause of these chronic diseases by directly attacking the adipocyte dysfunction and adipose tissue inflammation. Because these patients have multiple issues (adipocyte dysfunction, nutritional imbalance, inadequate lifestyle), it is important to address all of the issues to effectively manage the disease. To that end, LNC developed ‘The Chronic Patient Initiative’, a support program that operates in tandem with patient care.
Stablor is a multi-patented medical nutrition product dedicated to all patients with abdominal obesity (overweight and obese) and co-morbidities (high triglycerides, pre-diabetes and low high-density lipoprotein cholesterol or ‘good cholesterol’). The results arising from the Obeminale program have all confirmed that Stablor has a key role to play against abdominal obesity.
The Obeminale program had three main objectives:
• To understand the physiopathological mechanisms connected to abdominal obesity (inflammation, IR, microbiota, etc.) in order to identify bioactive molecules of therapeutic interest • To demonstrate the added value of Stablor (primarily its efficiency and safety) for every patient with abdominal obesity and disturbed biomarkers • To validate how Stablor will meet the needs of prescribers, medical practices and patients themselves
The most interesting aspect of the Obeminale program was an ambitious clinical study launched in 2012 with the ICAN (Institute for Cardiometabolism and Nutrition, France). This institute is among the most renowned research centers on the metabolic syndrome. The study involved 118 patients for 12 weeks. The results for this international (INAF, Institute of Nutrition and Functional Foods, Canada), controlled, randomized, double blind, multi-centric Obeminale study are still in ongoing analysis. Final results should be published in H1 2015.
The preliminary results of the Obeminale study have already confirmed the specific action of Stablor on fat mass and its metabolic impact on the biomarkers of adipocyte dysfunction, inflammation and insulin resistance. The safety and compliance are also excellent.
Earlier in the Obeminale program, LNC achieved a proof of concept study with Stablor. The main objective was to obtain a ten per cent waist loss. 92 patients took part for a duration of 21 weeks and 58 per cent of these had normalized their waist with a mean reduction of 9.2 cm, with an impact on insulin resistance (Homa IR: minus 35 per cent). The maintenance of the effect (waist circumference reduction) is also demonstrated in another publication with a 22 month follow-up (n equals 43). Full results were published in 2013. (2)(3)
“Obesity is complex to manage because physiopathology, nutritional and motivational aspects are interconnected. This is why we decided to collect clinical and real life data from patients and prescribers. We are delighted to have completed this major milestone in our development plan,” said Jean-Luc Treillou, CEO of LNC. “Following the success of this program, we will soon announce the launch of our next new therapeutic area related to abdominal obesity. In parallel, an identification and characterization study of the bioactive peptides in Stablor is ongoing, to validate the clinical outcomes.”
“The preliminary Obeminale study results are interesting at the clinical level and regarding the adipocyte dysfunction,” said Claude Vincent, president of LNC. “Some data on microbiota are under analysis. It is exciting because such global analysis is rarely performed.”
Stablor is now ready to be prescribed to any patient living with abdominal obesity and co-morbidities. As a product, Stablor could strengthen the portfolio of any major pharmaceutical company with a cardiometabolic focus.
“A number of options are now open to us. The most likely is an acquisition by a major pharmaceutical company to accelerate the market launch of our current portfolio, making it available to larger numbers of users, while reinforcing the scientific perspectives on LNC clinical research plans,” said Jean-Luc Treillou.
About LNC
LNC (Laboratoires Nutrition et Cardiometabolisme) is a research and development company specialized in the treatment of chronic metabolic diseases such as pre-diabetes and obesity. Using bioactive peptides, LNC targets the cause of these chronic diseases by directly attacking the adipocyte dysfunction and adipose tissue inflammation.
LNC’s portfolio comprises two ranges of medical nutrition product, both at the marketing stage. Stablor(R) is for individuals presenting with abdominal obesity and biomarker abnormalities (pre-diabetics and the obese). Bariamed(R) is for obese patients about to undergo surgery for obesity (known as bariatric surgery).
The company also has a diversified pipeline of medical nutrition products and candidate drugs spanning from initial research to phase III trials and covering the full extent of cardiometabolism. The products at the most advanced stage have been through clinical trials to demonstrate their efficacy and tolerance. LNC has filed 11 patents since it was founded in 2010.
The nature of chronic diseases requires an all-encompassing program of care involving patients and professionals. In response, LNC has devised the Chronic Patient Initiative, a supportive approach that aims to educate and provide guidance and encouragement for the patient and their family.
LNC is based in Bordeaux, France and has ten members of staff. The management team has extensive knowledge of the pharmaceutical industry (with experience at GSK, Aventis, Sanofi and Pfizer). Since it was founded, the company has raised EUR 9 million from equity investors and public funding.
Further information is online: http://l-n-c.fr
About pre-diabetes and obesity
Pre-diabetes is a borderline state that precedes the emergence of diabetes. There are currently 320 million pre-diabetics worldwide, 70 per cent of whom will develop diabetes within the next ten years without appropriate care (figures from The Lancet, 2012). The number of diabetics is set to increase by 55 per cent, taking the total number of sufferers to 592 million within the next 20 years (International Diabetes Federation, 2013).
Obesity is a disease that is acknowledged to have reached pandemic proportions. In fact, around 2 billion people worldwide over the age of 20 currently suffer from obesity or are overweight. By 2015, 2.3 billion adults will be overweight and over 700 million individuals will be obese (WHO, 2010). Patients suffering from obesity are characterized by an elevated body mass index. The condition often causes numerous health problems and obese patients are particularly prone to develop type II diabetes.
(1) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960460-8/abstract
(2) Dr. Bruno Ranson, M.D “Impact of a Nutritional Intervention on Waist Circumference Reduction” Science Journal of Medicine & Clinical Trials, 2013. http://www.sjpub.org/sjmct/sjmct-263.pdf
(3) Dr. Bruno Ranson, M.D ,”Maintenance of waist circumference reduction after a nutritional intervention : A 22-month follow-up” Science Journal of Medicine & Clinical Trials, 2014. http://www.sjpub.org/sjmct/sjmct-206.pdf
To view the original release: http://www.ala.com/article.php?id=416
Mark Tidmarsh
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