PHARMACY

Obesity drug beloranib shows promise in Prader-Willi population in Phase 2 trials

BY Michael Johnsen

CAMBRIDGE, Mass — Zafgen on Wednesday announced initial results from its Phase 2a study of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome, a severe form of genetic obesity. These results showed improvements in body weight, hunger-related behaviors and body composition, including reductions in body fat content and preserved lean body mass following four weeks of treatment. 

These changes were observed despite the increased caloric intake that was a component of this trial. Known markers of beloranib response, including those associated with cardiovascular disease risk, were also improved, demonstrating that PWS patients responded to the molecular mechanism of beloranib.

“The results of this short-term, proof-of-concept study are very promising and underscore our belief that beloranib has the potential to successfully treat this severe form of obesity. To our knowledge, this study represents the largest placebo-controlled, randomized, multiple-dose trial to date for obesity in this patient population, and these results bode well for further study of beloranib in patients with this devastating condition,” said Thomas Hughes, president and CEO Zafgen. 

Similar to results seen in non-PWS obese patient populations, beloranib treatment in this study reduced body fat content by 8.1% vs. placebo in four weeks of treatment at the highest study dose of 1.8 mg, despite a 50% increased daily caloric allowance. Hunger-related behaviors improved, and a trend toward overall improvement in body weight was seen, although this did not reach statistical significance, in part due to the fact that study was not powered to demonstrate these differences. 

Key hormones, including adiponectin and leptin, also showed changes characteristic of non-PWS obese patients, demonstrating that the drug was highly active in these patients and had a similar effect to that seen in non-PWS patients. 

“These results are very exciting for the treatment of PWS, as most patients showed improvements in body weight, hunger-related behaviors and body fat content, despite the increased food intake included in the trial design,” said Jennifer Miller, associate professor of pediatric endocrinology, University of Florida, and principal investigator for the study. “PWS is a complex genetic disease that is difficult to treat and the results of this trial demonstrate that beloranib has a beneficial impact on this underserved patient population. Notably, we were encouraged by reports of fullness, a first-time occurrence for PWS patients who otherwise lack the capacity to feel sated after meals.”

“PWS patients remain severely impacted by their disease and are not treatable with other anti-obesity agents,” said Janalee Heinemann, director of research and medical affairs for the Prader-Willi Syndrome Association. “PWS represents one of the most severe forms of genetic obesity and we welcome these results, which are a significant step towards finding a treatment for those suffering from this life threatening condition.”

Beloranib, a novel obesity therapy that utilizes a unique mechanism of action, is being studied for its ability to reduce body weight and improve cardiometabolic risk factors in obese patients with and without PWS.

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Survey: Most osteoporosis patients prefer non-pill treatments

BY Alaric DeArment

SAN ANTONIO — Nearly three-quarters of osteoporosis patients prefer to take their medication in a form other than an oral solid, according to a new survey.

The survey was sponsored by drug maker Mission Pharmacal and conducted by Inspire, a company that develops health and wellness communities for patients and caregivers, using patients drawn from the online support community of the National Osteoporosis Foundation. It found that 74% prefer their medication in a form other than a capsule or tablet. Mission Pharmacal is the manufacturer of the drug Binosto, a water-dissolvable tablet that delivers the drug alendronate sodium as a strawberry-flavored fizzy solution.

The company said the purpose of the survey was to raise awareness of osteoporosis and encourage people to talk to their doctors about treatment options, and it showed that most patients with the condition want a choice in the medication they take.

"The results of this survey show that patients are interested in options," said Robert Recker, director of the Osteoporosis Research Center at Creighton University in Omaha, Neb. "We take medication compliance very seriously because we know it can result in fewer fractures with osteoporosis."

 

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NACDS: Research article supports MTM eligibility criteria reform for seniors

BY Antoinette Alexander

ARLINGTON, Va. — Reform of eligibility criteria for MTM services would improve access to care for seniors and boost medication adherence, according to an article co-authored by Laura Miller, senior economist with the National Association of Chain Drug Stores.

The article — titled “Should Eligibility for Medication Therapy Management be Based on Drug Adherence?” — is in the January 2014 Journal of Managed Care Pharmacy.

The article bolsters support for MTM as a key to better and more affordable health care, and backs reform of eligibility criteria to make MTM available to more Medicare beneficiaries. According to the article, MTM services would reach more patients with a history of not taking their medications correctly if eligibility requirements were changed to include Medicare Part D beneficiaries who take two prescription drugs. Currently, patients must take eight prescription medications to be eligible for MTM services under most Part D plans.

“Our findings suggest that current MTM eligibility criteria are not optimally targeted to capture underuse of and poor adherence to evidence-based medications for prevalent chronic diseases in the elderly,” the article concludes.

This latest article supplements a growing body of evidence that improving medication adherence — including use of MTM to help patients take medications as prescribed — helps to enhance patient health and improve healthcare affordability. Reports by the Congressional Budget Office and the Centers for Medicare and Medicaid Services, as well as articles in Health Affairs and the Journal of American Pharmacists, offer further support that appropriate medication use can improve health while lowering costs.

The increasing focus on MTM also has included action in the legislative and executive branches of government, with initiatives underway to refine eligibility criteria for MTM within Medicare.

Bipartisan support continues to grow for the proposed Medication Therapy Management Empowerment Act of 2013 (H.R. 1024 and S. 557). The legislation enjoys the co-sponsorship of 159 members of the U.S. House of Representatives and 30 members of the U.S. Senate — more than 35% of the Congress, NACDS stated. In addition, the Centers for Medicare & Medicaid Services projects that MTM eligibility changes included in its Medicare Part D proposed rule published last week could increase the number of eligible beneficiaries from 2.5 million to 18 million.

“These efforts by Congress and the Administration to improve access to MTM are good public policy and wise strategies for improving the quality and cost-effectiveness of public health,” said NACDS president and CEO Steve Anderson. “Pharmacists are widely trusted healthcare professionals with extensive education. They are trained medication specialists who work collaboratively with physicians and with other healthcare professionals to help patients use medicines safely and stay healthy.”

 

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