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beloranib results

beloranib shows dramatic weight loss after 12 weeks

Patients treated with beloranib showed improvements in cardiometabolic risk factors

The results from a Phase II study assessing the experimental obesity drug beloranib, have revealed that patients lost up to 10kg (22lbs) in three months. The results, announced at the American Diabetes Association meeting in Chicago., IL, also showed that patients had lower levels of triglycerides and low-density lipoprotein, and felt less hunger after 12 weeks.

“The need for new options for severely obese patients has never been greater,” said Dr Caroline Apovian, professor of Medicine and Pediatrics, in the section of Endocrinology, Diabetes, and Nutrition, at Boston University School of Medicine.  “Beloranib is showing promise as a novel approach in this field, and the dramatic weight loss seen after only 12 weeks is very impressive.”

Zafgen, the company who holds exclusive worldwide rights (exclusive of Korea) for development and commercialisation of beloranib after licensing beloranib from CKD Pharma in Korea, said that the drug works differently from obesity therapies that have recently entered the market from Vivus and Arena Pharmaceuticals, which aim to control appetite through the brain. Beloranib targets an enzyme, MetAP2, that regulates fatty acids. By inhibiting MetAP2, the drug helps to convert stored fats into energy.

The outcomes presented were from the first 19 obese Caucasian women to complete the 148-person study. The pre-specified interim analysis reflects results obtained in the first 19 patients completing 12 weeks of treatment with 0.6mg (n=5), 1.2mg (n=6), or 2.4mg (n=3) of subcutaneous beloranib vs. placebo (n=5) as an initial dose-selection cohort that preceded enrolment of the complete Phase 2 study, for which results are expected in summer, 2013.

The Phase II double-blind, placebo-controlled study is investigating the safety, tolerability, pharmacokinetics and metabolic effects of beloranib in obese men and women. 

Patients received beloranib or placebo administered through subcutaneous injections given twice-weekly over a 12-week period.  Patients were allowed to eat normally and were not counselled to change their exercise habits. 

They had a mean age of 40.3 years, body weight of 101.2kg, and BMI37.9kg.  Patients receiving 12 weeks of treatment in the full trial were randomized to 0.6mg (n=37), 1.2 mg (n=37), or 2.4 mg (n=36) of subcutaneous beloranib vs. placebo (n=38). 

The drug appeared safe and showed dose responsive weight loss. After 12 weeks, subjects on 0.6mg, 1.2mg, or 2.4 mg lost an average of  (±SEM) -3.8±0.8kg, -6.1±1.5kg, and -9.9±2.3kg, respectively, vs. +1.8± 0.4kg for placebo (all p<0.005 vs. placebo). 

Additionally, patients treated with beloranib showed improvements in cardiometabolic risk factors including reduced triglycerides, LDL cholesterol and C-reactive protein vs. placebo. Sense of hunger also was reduced significantly.

Beloranib treatment for 12 weeks generally was well-tolerated by subcutaneous administration. The most common adverse effects with higher incidence during beloranib treatment were nausea, vomiting, and sleep disturbance. There were no severe or serious adverse events or deaths.

“We are encouraged to see such promising results with our longest duration of treatment to date,” said Dr Thomas E Hughes, President and CEO of Zafgen. “The results mark a major milestone for Zafgen and set the stage for advancement to more comprehensive trials to establish safety and efficacy of beloranib.”

Results from the complete Phase 2 study are expected in the second quarter of 2013. 

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