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ZGN-1061 outcomes

Zafgen presents results for ZGN-1061 from Phase 2 Clinical Trial

Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and beta-cell function
Company announces regulatory update on ZGN-1061

Zafgen has 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, as well as a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycaemic control, including insulin sensitivity and beta-cell function.

Zafgen previously announced positive results from its Phase 2 clinical trial conducted outside the US, including data for the second cohort that included doses up to 1.8mg, in January 2019. The clinical trial met all of its primary objectives at the 1.8mg dose, which included glycaemic control or change in A1C, safety and tolerability. The 12-week data demonstrated that treatment with the 1.8mg dose of ZGN-1061 produced substantially more improvement in A1C versus placebo than the 0.9mg dose versus placebo. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8mg dose. The data showed a favourable 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 glycaemic 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-1,061 (p<0.001 for both the 0.9 and 1.8mg 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+1.8mg 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.

Update on ZGN-1061

Zafgen has also received the minutes from its Type A meeting with the FDA regarding the clinical hold for ZGN-1061. The company provided key new data in advance of the meeting, including newly developed in vitro assays of human plasma coagulation using endothelial cells and assessment of tissue factor expression with endothelial cells, and other supportive new assays. The company is working with FDA to gain alignment on an in vivo animal model to confirm relevant safety margins as a next step toward resolving the clinical hold. Zafgen will be prepared to rapidly implement the agreed upon work.

“The Type A meeting with the FDA for ZGN-1061 was marked by constructive dialogue and progress driven by the important new data that the team worked diligently to provide to inform the discussion. This effort for Zafgen was led by highly experienced members of our team, Dr Priya Singhal, our new Head of R&D, and Lisa Percival, our Vice President of Regulatory,” said Jeffrey Hatfield, Chief Executive Officer. “We believe the new in vitro data generated was encouraging, and the FDA was helpful with guidance regarding data needed to move forward in type 2 diabetes.”

Additionally, the company is evaluating serious, rare disease indications that have few or no approved therapies in which ZGN-1061 could potentially benefit patients. The FDA was supportive of Zafgen seeking guidance on a second investigational new drug application for ZGN-1061, as appropriate.

Zafgen will provide an update on development plans by the end of the third quarter of 2019.

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