Media release from GlobalData

LONDON, UK (GlobalData), 27 September 2012 - Highlights of the "Obesity 2012" conference in terms of drug development news and epidemiological research may be the spark needed by both the biopharmaceutical industry and the public health community to re-focus attention on the treatment and prevention of obesity.

The Obesity Society's prominent 30th Annual Scientific Meeting, held in San Antonio, Texas from September 20-24, provided the platform for the presentation of much-anticipated clinical trial results from some of the only companies with active drug development programs in obesity-Vivus, Zafgen, and Unigene-as well as a keynote debate and new epidemiological research on the link between sugar-sweetened beverages and obesity. With the global prevalence of obesity rising at an alarming rate, the drug development research community has been struggling to identify promising solutions, but the data presented at this conference reveal a changing landscape. Both Zafgen's beloranib and Unigene's UGP281 stand to become first-in-class market entrants; beloranib's advantage lies primarily in its novel mechanism of action, while UGP281's lies in its strong cardiovascular safety profile.

Among the meeting's headliners was Vivus, which presented four abstracts on the trial results of its newly-FDA-approved obesity drug, Qsymia, which combines low doses of two known agents, phentermine and topiramate, in an extended-release capsule. The presentation of these results, which were largely positive, came on the heels of a company statement suggesting that European approval of the drug is not guaranteed.
On the second day of the conference, Vivus announced that the EMA is likely to advise against the drug's approval next month. Although neither Vivus nor European regulators have publicly acknowledged the reason for concern about the drug, its inclusion of phentermine is a likely suspect. Made famous in the 1990s as an ingredient in the appetite suppressant combination drug 'fen-phen', which caused fatal heart valve damage and pulmonary hypertension, phentermine was not actually implicated in that drug's serious adverse effects profile; the fenfluramine component was eventually blamed for the heart damage. Nonetheless, Qsymia's resurrection of phentermine may ultimately cause its failure to launch in the European market.

Late-stage results from three Phase III trials of Qsymia showed that the drug effectively reduced subjects' weight, improved blood sugar control among type 2 diabetics, and decreased cardiovascular risk factors such as elevated blood pressure and triglycerides.  Data from the 56-week EQUIP study to evaluate safety and efficacy, indicated that patients taking Qysmia at a dose concentration of 15 mg phentermine/92 mg topiramate, in combination with a diet and lifestyle modification program, lost up to 14.4% of baseline weight, compared to just 1.6% with placebo. Furthermore, nearly half the patients who completed the trial lost ≥15% of their body weight. Compared with clinical trial results from Arena's Belviq, which was also recently approved by the FDA for the treatment of obesity based on its 5-10% reduction of body weight in clinical trial subjects, these results suggest that Qsymia may demonstrate superior real-world efficacy.

The privately-held biopharmaceutical company Zafgen presented data from two Phase 1b studies of beloranib, its first-in-class selective inhibitor of methionine aminopeptidase 2 (MetAP2). The results showed positive efficacy in terms of inducing rapid weight loss, reducing fat, and improving cardiovascular disease risk markers in severely obese women. Beloranib's novel mechanism of action puts it in its own league, with no near-term threat from other competitors.

Unigene Pharmaceuticals presented data from its preclinical studies of UGP281, a novel anorexigenic amylin peptide. This subcutaneous drug targets the amylin receptor and was found in these trials to produce a dramatic reduction in food intake and a sustained, dose-related decrease in body weight of 10-15%, achieved at relatively low doses using animal models. Unigene's proprietary Peptelligence formulation technology allows the peptide UGP281 to be administered orally rather than by intramuscular injection. If the drug sustains positive efficacy in clinical trials, it will successfully overcome the formulation and efficacy-related hurdles faced by previous developers of anorexigenic, peptide-based drugs, and its cardiovascular safety profile will position it optimally within the obesity market.

Beyond trial results from the drug development pipeline, the conference showcased epidemiological data with the potential to spark public health action across the country. In conjunction with newly-published reports in the New England Journal of Medicine, three epidemiological studies presented compelling evidence that people who have obesity-related genetic variants may be predisposed to the development of obesity, which can be exacerbated by the consumption of sugar-containing beverages. In addition, the studies concluded that reducing children's and adolescents' consumption of these beverages leads to lower BMIs and reduced weight gain. These findings represent the first set of concrete evidence that sugary beverages are a culprit in the increasing prevalence of obesity, particularly among children. In fact, Dr. David Allison, the director of the Nutrition Obesity Research Center at the University of Alabama at Birmingham, who had previously denied that such a link existed, acknowledged in a written statement that the studies on children provide key evidence - reducing sugary beverage consumption can help reduce weight in overweight or obese children. These reports will provide leverage for public health advocates and government officials to bring about policy changes akin to that recently made by New York City Mayor Michael Bloomberg, who supported a ban on sugary beverages in schools and the elimination of super-sized soft drinks.