Biotech Values

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ZFGN...apparently the P1 had been ongoing in healthy subjects for some time though not listed on clinicaltrials.gov. The PR was for the initiation of MAD cohorts in obese subjects...

Zafgen, Inc. (ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing Phase 1 clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a review of the initial safety and tolerability data from the first two cohorts of the single ascending dose (SAD) portion of the clinical trial.

The Phase 1 clinical trial is evaluating safety, tolerability, and weight loss efficacy over four weeks of treatment. The clinical trial includes a SAD portion, which will enroll up to 48 healthy subjects across up to six cohorts of single escalating doses of ZGN-1061. The clinical trial also includes a MAD portion, which is evaluating twice-weekly ZGN-1061 over four weeks in up to 24 obese subjects. Key elements of the clinical trial involve evaluation of the uptake and elimination of ZGN-1061, or pharmacokinetics, and evaluation of endpoints related to blood coagulation. The Company continues to expect top-line data from the clinical trial by the end of the first quarter of 2017.

“The clinical trial is progressing well, and we are particularly encouraged that there have been no significant safety signals or tolerability concerns observed in patients treated to date,” stated Dennis Kim, M.D., Chief Medical Officer of Zafgen. “