Ersatta: Phase Ib/IIa data
Top-line data from 42 Type I diabetics with signs of peripheral neuropathy in the Phase IIa portion of a double-blind, U.S. Phase Ib/IIa trial showed that subcutaneous Ersatta significantly improved mean sural SNCV from baseline to day 85 vs. placebo (1.1 vs. 0.6 m/sec, p<0.005). Additionally, Ersatta improved VPT by a reduction of 0.55 vibration units vs. 0.42 vibration units for placebo. Ersatta reduced peroneal MNCV by 0.06 m/sec vs. a 0.3 m/sec increase for placebo. Ersatta was well tolerated with no serious adverse events reported. Additionally, no clinically significant injection-site reactions, treatment-related hypoglycemia or anti-drug antibody formation was reported. Adverse events included more sensitive finger tips, tingling sensation, bilateral pinching hands and feet, nausea, diarrhea, increased creatinine kinase and dizziness. Patients received placebo or a 2 mg loading dose of subcutaneous Ersatta followed by once-weekly 0.8 mg subcutaneous maintenance injections for 11 weeks. Data were presented at the European Association for the Study of Diabetes meeting in Berlin. ...