Zafgen Announces Positive Full Results in Phase 2 Proof-of-Concept Trial of ZGN-1061 in Patients with Difficult-to-Control Type 2 Diabetes
Trial met all primary objectives, demonstrated efficacy and safety and established minimally effective dose of 0.9 mg for ZGN-1061
Patient dosing recently initiated for the 1.8 mg dose cohort
Company to hold conference call on
“These positive Phase 2 data show clinically relevant efficacy, favorable safety profile and dose responsive results in line with our expectations for this proof-of-concept trial in patients with type 2 diabetes,” said
ZGN-1061 demonstrated a statistically significant reduction in A1C at 0.9 mg versus placebo at Week 8 (p<0.01) and Week 12 (p<0.001). A1C lowering results from the trial establishes the 0.9 mg dose as a minimally effective dose, with progressive A1C lowering to 12 weeks with no signs of waning of effect. The 0.9 mg dose in this trial represents approximately 50% target engagement of MetAP2. These results were well-supported by several relevant metabolic biomarkers, including postprandial and fasting plasma glucose, FGF21, adiponectin and leptin. ZGN-1061 was generally safe and well-tolerated, with primarily mild to moderate adverse events (AEs) and an overall high study completion rate (95%). The most frequent AEs were injection site bruising, upper respiratory infection, and diarrhea that was mild and self-limiting. Serious adverse events – upper abdominal pain and skin ulcer – were reported by two patients on treatment and deemed not related to study drug by the principal investigator. Importantly, there were no elevations in D-dimer concentrations across the dosing groups as compared to baseline or placebo and no CV safety signals observed.
In addition to the Phase 2 clinical data for ZGN-1061,
“The clinical data announced today for ZGN-1061 reinforce our excitement about the potential of our second-generation MetAP2 inhibition platform to address advanced, complex type 2 diabetes, while also providing a potential safety read-through to our rare disease programs with high unmet medical need, starting with Prader-Willi syndrome,” said
As previously announced, based on the safety and tolerability results of the interim analysis for the ZGN-1061 Phase 2 proof-of-concept trial detailed in
“The results of the Phase 2 trial announced today, together with the data we expect to generate at the higher 1.8 mg dose, further strengthen ZGN-1061’s position as one of the most attractive and innovative clinical stage programs for the treatment of type 2 diabetes in the industry,” said
Full data for these studies are available in the posters being presented at the ADA meeting and will be discussed in a conference call on
Conference Call Information
Zafgen will host an investor conference call
Poster Information:
Poster Hall,
105-LB: Results of an Interim Analysis of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of ZGN-1061 in Patients with Type 2 Diabetes and Obesity: Update with Full Results
Authors: T. Kim, D. Zhuang,
108-LB: ZGN-1061, a Novel MetAP2 Inhibitor, and Liraglutide Combine to Improve Glycemic Control and Reduce Body Weight in a Rat Model of Diet-Induced Obesity
Authors:
107-LB: ZGN-1061 Improves Metabolic Parameters and Hepatic Pathology in an Obese Mouse Model of Diet-Induced and Biopsy-Confirmed Nonalcoholic Steatohepatitis
Authors:
About Zafgen
Safe Harbor Statement
Various statements in this release concerning Zafgen’s future expectations, plans and prospects, including without limitation, Zafgen’s expectations regarding the use of ZGN-1258, ZGN-1061 and other second-generation MetAP2 inhibitors as treatments for metabolic diseases including Prader-Willi syndrome, type 2 diabetes, liver diseases and obesity and Zafgen’s expectations with respect to the timing and success of its nonclinical studies and clinical trials of ZGN-1258, ZGN-1061 and its other product candidates, may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Zafgen’s ability to successfully demonstrate the efficacy and safety of ZGN-1258, ZGN-1061 and its other product candidates and to differentiate ZGN-1258, ZGN-1061 and its other product candidates from first generation MetAP2 inhibitors, such as beloranib, the nonclinical and clinical results for ZGN-1258, ZGN-1061 and its other product candidates, which may not support further development and marketing approval, actions of regulatory agencies, which may affect the initiation, timing and progress of nonclinical studies and clinical trials of its product candidates, Zafgen’s ability to obtain, maintain and protect its intellectual property, Zafgen’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, Zafgen’s ability to manage operating expenses, Zafgen’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives when needed, Zafgen’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Zafgen’s most recent Annual Report on Form 10-K filed with the
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Source: Zafgen, Inc.