May 18, 2007 — Genaera Corp. announced that dosing of subjects has begun in study MSI-1436C-101, the Phase 1, first-in-man study of trodusquemine, its novel antiobesity compound. MSI-1436 works centrally and peripherally to regulate insulin and leptin receptor signaling through inhibition of its novel target enzyme PTP-1B.
This randomized, vehicle-controlled study, being conducted at a leading obesity clinical research center in Kansas City, MO, 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 approximately 35 subjects and is expected to be completed in the second half of 2007.
"We are very pleased that we have met this clinical milestone and can begin to collect human data on this promising compound," said Jack Armstrong, president and chief executive officer of Genaera. "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."