Cambridge, MA-based Zafgen has taken another big step forward in its quest to develop a unique new weight drug. The biotech has laid out its plans for its first Phase IIa study of beloranib, which inhibits the MetAP2 enzyme.
Zafgen CEO Tom Hughes says that investigators will set out to see if they can replicate the kind of dramatic efficacy seen in Ib studies, enrolling 150 obese patients with and without Type 2 diabetes. Data from the Phase IIa study should be ready in June, 2013.
In earlier studies Zafgen investigators tracked dramatic weight loss in patients, with patients dropping about a kilo a week over four weeks. The goal now is to see if they can continue that trend out over 12 weeks, setting them on a pace that would eventually lead to large-scale Phase III studies that would be needed to demonstrate efficacy and safety in even bigger groups of patients. If beloranib can succeed at that, then Zafgen would be in a position to make a case that the drug could replace bariatric surgery, offering big health gains in a relatively quick time span.
"If the product bears the fruit of its potential as an alternative to bariatric surgery, we'll need to see continued weight loss," Hughes tells FierceBiotech this morning. Zafgen, a 2009 Fierce 15 company, has long been one of the standout virtual companies in the industry, currently operating with a small staff of 5. Hughes says that the employee roster is likely to swell to 10 as it gets deeper into Phase II. In the meantime it's been exploring its options for a sale, but Hughes says that for now he's interested in keeping all his options open, with more money to raise in 2013 and a chance at partnerships as well.
This is a much better regulatory and development environment for experimental weight drugs, adds Hughes. And Zafgen is likely to benefit from it.
- here's the press release
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