An analyst called the data, on ZGN-1061, encouraging in a relatively small study but added that more preclinical data will be needed to give a clearer picture of the way forward for the drug.
The drug is a MetAP2 inhibitor, which according to a poster from the study is part of a class that has previously improved glycemic control and body weight in human subjects, as well as improving various measures in mice. The analysis included 175 patients, who were randomized to receive either placebo or the drug at 0.05mg, 0.3mg, 0.9mg or 1.8mg.
Nevertheless, the Phase II study had to be conducted in Australia and New Zealand due to a clinical hold that the Food and Drug Administration placed on ZGN-1061 in November 2018, before Zafgen began clinical trials in the U.S. The hold stems from cardiovascular safety concerns that had read through from an earlier MetAP2 inhibitor from Zafgen, beloranib, which itself was placed on hold in December 2015. The company said May 30 that it had received minutes from its meeting with the FDA related to the hold, and that it would provide an update on development plans for the drug in the third quarter of this year.
In a note to investors Tuesday, Cowen analyst Yaron Werber wrote that while the Phase II data are encouraging in a relatively small study – consisting of 23-44 patients per arm – more preclinical data are needed to give greater confidence in whether the FDA will release the hold on ZGN-1061. He noted the company may try to file to start a clinical trial in a more severe indication to provide an alternative path forward.
“The data is encouraging yet a small step forward in a long road,” Werber wrote. “We expect the stock to remain range-bound until there is clarity on the path ahead.”