Isis : Phase 1 Clinical Trial of ISIS-FGFR4Rx a Peripherally Acting Drug to Treat Obesity

Calif., Dec. 20, 2011 - Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity. ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body's ability to store fat while simultaneously increasing fat burning and energy expenditure. Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects. Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects.

"Obesity is an epidemic in the United States and much of the rest of the industrialized world. Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers. Severely obese patients make up the most rapidly growing part of the obese population. In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients," said Richard Geary, Ph.D., Senior Vice President of Development at Isis. "Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles. Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects."... Isis Pharmaceuticals' Press Release -

Teva UK : generic anti-obesity drug Orlistat

12th December 2011 - Teva UK Limited launches generic anti-obesity drug Orlistat -

We are delighted to announce the first generic launch of Orlistat, generic equivalent to Xenical® (Orlistat) from Roche...

[...]

...“As the UK’s leading supplier of generics, we’re pleased not only to have the widest portfolio of our competitors, but also to show that we’re well-placed when it comes to innovation and being the first to market.”

Indication 

Orlistat is a generic version of prescription-only Xenical® from Roche and is indicated in conjunction with a mildly hypocaloric diet for the treatments of obese patients with a body mass index (BMI) greater or equal to 30kg/m2, or overweight patients (BMI ≥ 28kg/m2) with associated risk factors... Teva UK's Press Release -

Nestlé Health Science : Consensus panel calls for specialised nutritional therapy for the critically ill obese

September 13, 2011 - A newly published consensus report prepared by a panel of clinical experts, with sponsorship from Nestlé Health Science, reveals that there are opportunities to do more to manage the impact of obesity on the delivery of critical care, particularly in the area of nutrition therapy. With more than 25 percent of ICU patients considered to be obese or severely obese,1 the panel of clinical experts urges hospitals and medical professionals to adapt medical care traditionally designed to meet the needs of average-weight patients to the unique needs of the obese patient population. Patients with obesity, while heterogeneous as a population, are typically predisposed to greater morbidity, higher instances of infection and organ failure, and extended length of stay, all negative clinical outcomes that affect overall recovery.

“The lack of consistent standardized nutrition interventions for the critically ill patient with obesity means that some patients may be overfed and others may be underfed or malnourished. Some may never have their nutritional needs assessed. All of these scenarios can present problems with health outcomes and recovery rates,” said Dr Stephen McClave, M.D., professor of Medicine, University of Louisville, and moderator of the consensus panel.

The consensus report, published as a supplement to the September 2011 issue of the Journal of Parenteral and Enteral Nutrition (JPEN), explores multiple issues related to obesity in the critical care setting including the many challenges associated with applying standard nutrition therapy practice to the obese patient population. Areas of concern include assessment of nutritional status and nutrient requirements, as well as delivery of nutrients, including route of delivery, overfeeding of calories, underfeeding of protein and monitoring of feeding tolerance... Nestlé's Press Release -

Palatin : Phase 1 Trial for Obesity Compound in collaboration with AstraZeneca

August 4, 2011 – Palatin Technologies, Inc. (NYSE Amex: PTN) confirmed the commencement of a Phase 1 clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist, under development as a single-agent therapy for the treatment of obesity. AZD2820 is a clinical candidate selected by AstraZeneca from its collaborative research program with Palatin Technologies. 

Obesity is a global problem, with the World Health Organization estimating that over 1.5 billion adults are overweight and over 500 million are obese. Worldwide obesity has more than doubled since 1980. A number of different metabolic and hormonal pathways are being evaluated by companies around the world in efforts to develop better treatments for obesity. Scientific research has established that melanocortin receptors have a role in eating behavior and energy homeostasis, and that some melanocortin receptor agonists decrease food intake and induce weight loss in animal studies.

The single center study is expected to enroll 90 subjects in a randomized, single-blind, placebo-controlled, Phase 1 trial in healthy male volunteers... Palatin Technologies' Press Release -

VIVUS : Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment

Nov. 3, 2011 - Weight Loss Accompanied by Improvements in Cardio-Metabolic Risk Factors -

VIVUS, Inc. (NASDAQ: VVUS) announced that results from the 56-week EQUIP study were published in Obesity, the peer-reviewed journal of The Obesity Society. The EQUIP study evaluated the efficacy and safety of the investigational drug Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients across 91 sites in the US. In addition to average weight loss of 14.4% of initial body weight among those who completed the study at the top dose of Qnexa, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. The results with Qnexa suggest the potential to effectively treat severely obese patients without surgery.

"Obesity is a serious medical condition that threatens the public health and reduces the quality and length of lives. Currently available treatments are limited and options are needed," said lead investigator Dr. David Allison, director of the Nutrition Obesity Research Center, University of Alabama at Birmingham. "In this population of severely obese patients, those taking Qnexa experienced significant weight loss and reduction in risk factors for many chronic diseases. The results refute a common notion that nonsurgical treatments are not effective for extremely obese persons. The findings are especially relevant to the 14% of the US adult population classified as extremely obese."

Patients in the study had a baseline body mass index of >/= 35 kg/m2, and an average initial weight of 256 pounds. Treatment was well tolerated, with no evidence of serious adverse events induced by treatment... VIVUS' Press Release -