PLYMOUTH MEETING, Pa., May 7 /PRNewswire-FirstCall/ -- Genaera Corporation today announced that it has begun enrolling subjects in the first human clinical study of trodusquemine (MSI-1436) under the Investigational New Drug (IND) application for the obesity compound submitted to the U.S. Food and Drug Administration (FDA) in March 2007. The phase 1 study will enroll healthy overweight and obese volunteers to assess the safety and pharmacokinetics of ascending single doses of trodusquemine. The Company expects to dose the first subjects by the end of May 2007.
Trodusquemine is a centrally and peripherally-acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B (PTP1B), an enzyme target for the treatment of diabetes and obesity. Trodusquemine has produced consistent, sustainable weight loss in a variety of animal models and appears to overcome metabolic readjustment, which often limits sustained weight loss during caloric restriction. In addition, trodusquemine has shown the ability to reverse co-morbidities associated with obesity such as abnormal glucose metabolism and cholesterol elevation.
"We are pleased that FDA has given Genaera the green light to begin testing trodusquemine in humans and that we were able to efficiently execute our clinical program and proceed into the clinic," said Jack Armstrong, President and Chief Executive Officer of Genaera. "While the primary endpoint of this first phase 1 study is safety and tolerability, we will be looking for evidence supporting our pre-clinical observations that trodusquemine induces appetite suppression and weight loss while normalizing glucose metabolism and insulin sensitivity."
About Genaera
Genaera Corporation is a biopharmaceutical company focused on the development of innovative drug candidates in the areas of obesity, metabolic diseases and asthma. The Company is focusing on the development of trodusquemine (MSI-1436) as a treatment for obesity and diabetes, and the continuation of the anti-IL9 antibody program for the treatment of asthma. Genaera's other compounds include LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease; squalamine for the treatment of cancer; and LOCILEX(TM) (pexiganan acetate), a topical antimicrobial.
Genaera Corporation
