Zafgen, Inc., a biopharmaceutical company, focuses on the development of therapeutics for patients suffering from obesity and obesity-related disorders. Its lead product candidate includes Beloranib, an injection, which is in Phase III clinical trials for the treatment of obesity and hyperphagia in Prader-Willi Syndrome patients; that has completed Phase II clinical trials for the treatment of hypothalamic injury-associated obesity, including craniopharyngioma-associated obesity; and which is in Phase IIb clinical trials for the treatment of severe obesity in the general population. The company is also developing ZGN-839, a methionine aminopeptidase 2 inhibitor, which is in preclinical studi...
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Founded in 2005
Zafgen, Inc. Presents at UBS Global Healthcare Conference, May-18-2015
May 13 15
Zafgen, Inc. Presents at UBS Global Healthcare Conference, May-18-2015 . Venue: Sheraton New York Times Square Hotel, 811 Seventh Avenue, New York, New York, United States.
Zafgen, Inc. Announces Consolidated Unaudited Earnings Results for the First Quarter Ended March 31, 2015
May 12 15
Zafgen, Inc. announced consolidated unaudited earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported loss from operations of $13,240 compared with $4,521 for the same period a year ago. Net loss attributable to common stockholders was $13,472 or $0.53 per basic and diluted share compared with $4,507 or $6.18 per basic and diluted share for the same period a year ago.
Zafgen, Inc. Presents Positive Safety and Efficacy Data from Phase 2 Trial of Beloranib
May 8 15
Zafgen, Inc. announced positive efficacy and safety data from its ZAF-201 Phase 2 trial of beloranib, a MetAP2 inhibitor, in obese patients. The company also announced efficacy and safety data from ZAF-211, a proof of concept study of beloranib in patients with Prader-Willi syndrome (PWS). These findings, presented at the 22ndEuropean Congress on Obesity (ECO) on May 7-8, 2015 in Prague, Czech Republic, demonstrated meaningful weight loss and improvement in cardiometabolic biomarkers. Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces drive to eat while stimulating the use of stored fat as an energy source. Severe Obesity Results (ZAF-201): ZAF-201, a Phase 2 randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety and tolerability of beloranib 0.6 mg, 1.2 mg or 2.4 mg administered as twice-weekly subcutaneous injections for 12 weeks in patients with severe obesity. The trial enrolled 147 men and women, of which 117 completed the study. The mean age of patients was 48.4 years, and body mass index (BMI) and body weight (BW) was consistent with Class 2 obesity (approximately 38 kg/m2 and 100 kg, respectively). Patients were not counseled to adhere to any diet or exercise regimens as part of the trial. Results from this trial showed that 12 weeks of treatment with beloranib led to sustained, progressive, and dose-dependent weight loss of up to 11 kg from baseline. Additionally, beloranib treatment significantly reduced sense of hunger and prospective food intake, and known markers of beloranib response, including major cardiovascular risk factors and markers of inflammation, were also improved at 12 weeks. Significant reductions in total and LDL cholesterol and triglyceride levels and an increase in HDL cholesterol were noted in the beloranib 2.4 mg group. A significant increase in HDL cholesterol and decrease in triglyceride levels was observed with beloranib 1.2 mg. Consistent with reduced fat mass and improved adipose tissue function and inflammation, significant (p<0.001) changes in adiponectin, leptin, and hs-CRP were observed with beloranib. PWS Results (ZAF-211): PWS is the most common known genetic cause of life-threatening obesity and results in constant and unrelenting hunger that drives patients with PWS to engage in problematic hunger-related behaviors and gain excessive weight. As a result, many of those affected become morbidly obese and suffer significant mortality. The proof of concept study with beloranib enrolled adult patients with PWS and started with a two-week, single-blind, placebo lead-in period followed by a four-week, double-blind, randomized, treatment period of beloranib 1.2 mg, 1.8 mg, or placebo administered as twice-weekly subcutaneous injections. An optional four-week, open-label extension phase was also offered to patients. The trial enrolled 17 patients with confirmed PWS, all of whom completed the study, with a mean age of 33.5 years, mean BMI of 31.4 kg/m2 and mean BW of 71.8 kg. The study design allowed for a 50% increase in calorie intake for the duration of the study to account for stringent calorie restriction being enforced at the group home where these patients were housed.