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Zafgen Reports First Quarter 2017 Financial Results
-ZGN-1061 Phase 1 Data Support Continued Development; On Track to Initiate Phase 2 Clinical Trial in Patients with Type 2 Diabetes in Second Half of This Year-
BOSTON, May 9, 2017 Zafgen, Inc. (Nasdaq:ZFGN), today announced its first quarter 2017 financial results.
We recently achieved an important milestone in our clinical program for ZGN-1061, reporting positive topline data from the Phase 1 clinical trial of ZGN-1061, a MetAP2 inhibitor which has been optimized to improve glycemic control and body weight, with a favorable safety profile, said Thomas Hughes, Ph.D., President and Chief Executive Officer of Zafgen. The safety data and the early efficacy signals support the further development of this compound, and we plan to advance ZGN-1061 into a Phase 2 clinical trial in the second half of this year in patients with type 2 diabetes who are overweight or obese.
Recent Clinical Highlights
|||Earlier this month, Zafgen reported positive topline data from both the SAD and MAD portions of the Phase 1 clinical trial of ZGN-1061, the Companys second generation MetAP2 inhibitor. ZGN-1061 was safe and well-tolerated, with no serious adverse events (SAEs), and no severe adverse events (AEs). There were no AEs leading to early withdrawal from the clinical trial.|
|||There was no prothrombotic effect observed with ZGN-1061. No treatment emergent venous thromboembolisms (VTEs), no clinically meaningful D-dimer elevations indicative of thrombosis and no elevations in mean D-dimer levels were observed in the dosing groups compared to baseline or placebo. There were no clinically significant changes in coagulation laboratory parameters or other key biomarkers of interest, including von Willebrand factor, soluble thrombomodulin, and plasminogen activator inhibitor-1.|
|||On average, patients treated with ZGN-1061 for four weeks lost weight relative to placebo-treated patients (-4.6 lbs, -2.2 lbs, and -3.8 lbs for 0.2 mg, 0.6 mg, and 1.8 mg, respectively vs. -0.51 lbs for placebo), with trends for improvements observed in waist circumference, food intake, low density lipoprotein-cholesterol, C-reactive protein, adiponectin and leptin.|
|||Based on the positive data from the Phase 1 clinical trial, together with non-clinical data supporting a differentiated profile and improved safety margin versus first generation MetAP2 inhibitors, the Company plans to initiate a Phase 2 clinical trial of ZGN-1061 in the second half of this year, in patients with type 2 diabetes who are overweight or obese.|
First Quarter 2017 Financial Results
Our focused and disciplined investment in ZGN-1061 will allow us to take this lead candidate through key value-creating milestones with our current resources, stated Patricia Allen, Chief Financial Officer of Zafgen. We continue to expect our cash runway to extend through the end of 2018, by which time we expect to have data from the Phase 2 clinical trial for ZGN-1061.
The following information was filed by Zafgen, Inc. (ZFGN) on Tuesday, May 9, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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