Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Mon June 10, 2019 7:00 AM|GlobeNewswire|About: ZFGN
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg
Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and beta-cell function
BOSTON, June 10, 2019 (GLOBE NEWSWIRE) -- Zafgen (ZFGN), Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, today announced that the Company presented the full results of its Phase 2 clinical trial for ZGN-1061 in an oral presentation at the American Diabetes Association's 79th Scientific Sessions. Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
Zafgen previously announced positive results from its Phase 2 clinical trial conducted outside the U.S., including data for the second cohort that included doses up to 1.8 mg, in January 2019. The clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability. The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C versus placebo than the 0.9 mg dose versus placebo. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed a favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed in the trial.
The Phase 2 clinical trial also examined the effects of ZGN-1061 on other markers of glycemic control. In data presented during the poster session, patients who participated in a mixed-meal tolerance test demonstrated significant improvements in postprandial glucose excursion with ZGN-1061 (p<0.001 for both the 0.9 and 1.8 mg doses) and a trend for improvement in insulin levels from baseline to Week 12. ZGN-1061 also demonstrated improvement in beta-cell function and insulin sensitivity in an exploratory combined analysis of 0.9+1.8 mg ZGN-1061 (p=0.02 and p=0.07) using a modeling approach. These data suggest improved glycemic control with ZGN-1061 may be driven by changes in insulin sensitivity and beta-cell function in this population of patients with advanced diabetes.
The poster will be available on the Company’s website.
About Zafgen
Zafgen is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders. Learn more at www.zafgen.com.
