Genaera initiates dosing in Ph I trodusquemine trial

Pennsylvania, USA-based Genaera says that dosing of subjects has begun in study MSI-1436C-101, the Phase I, first-in-man trial of trodusquemine (MSI-1436), its novel anti-obesity compound. The agent works centrally and peripherally to regulate insulin and leptin receptor signaling through inhibition of its novel target enzyme PTP-1B, the firm explained.

This randomized, vehicle-controlled study, being conducted at a leading obesity clinical research center in Kansas City, is enrolling healthy overweight and obese volunteers to evaluate the safety, tolerability, and pharmacokinetics of ascending single doses of intravenously-administered MSI-1436. This ascending single-dose protocol will initially enroll around 35 subjects and is expected to be completed in the second half of 2007.

Jack Armstrong, chief executive of Genaera, said: "what we learn in this first stage of clinical testing will help us understand how MSI-1436 performs in the human body and guide the determination of an optimal therapeutic dose for the larger efficacy trials which follow. The efficiency and quality of this work will be important benchmarks for Genaera moving forward."