|FDA Calendar: Five Weight Loss Trades|
|Tuesday, 21 July 2009 17:45|
Below are five small/micro-cap companies from the BioMedReports.com FDA Calendar with late-stage drugs or medical devices in development for prescription weight loss. Nearly two-thirds or 65% of U.S. population is classified as obese or overweight with a three-fold increase in adolescent obesity rates over the past three decades. Obesity is the second leading cause of preventable deaths behind smoking and weight loss is proven to decrease mortality while also improving blood sugar control in diabetics. Over one-third (35%) of people in the U.S. have a lifetime of developing Type 2 diabetes and the trend is clearly increasing as a result of obesity rates, especially in the younger population.
On 3/30/09, Arena Pharma (NASDAQ:ARNA) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfied the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. Arena is on track to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end.
Vivus (NASDAQ:VVUS) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa. Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.
Topiramate is better known as Topamax, which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.
Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms being evaluated in Phase 3 clinical trials, with more than 4,500 patients currently enrolled in late-stage studies for weight loss and Type 2 diabetes control. Last year, Vivus reported results for Qnexa from the 28-week EQUATE Phase 3 clinical trial which met its primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the drugs used individually and placebo.
On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.
OREX is continuing to follow patients in a Phase 2b clinical trial of Empatic (zonisamide SR/bupropion SR), ZB-202. The trial is designed to build on the results from a previous Phase 2b trial of Empatic, ZB-201. In the current trial, which measures weight loss after 24 weeks of treatment, two different dosages of Empatic are being studied along with the individual constituents. The Company expects to report results from this Phase 2b clinical trial during 3Q09.
EnteroMedics (NASDAQ:ETRM) is developing implantable systems to treat obesity and other gastrointestinal disorders. VBLOC Therapy intermittently blocks nerve signaling between the brain and stomach over the vagus nerves using high-frequency, low-energy electrical impulses. The vagus nerves are known to control digestive functions including food processing and feelings of hunger and fullness. In blocking nerve function, VBLOC is designed to help patients feel hungry less and feel full sooner, therefore reducing how much they eat.
The effect of VBLOC Therapy has been demonstrated in early clinical trials, where patients reported reduced time to feelings of fullness at meals, as well as reduced feelings of hunger between meals out to six months with resultant reduced calorie intake. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008. ETRM expects results from the blinded portion of the study during 2H09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance.
On 6/8/09, NeuroSearch (CPH:NEUR) announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.
The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.
Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.
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