In the study, trodusquemine was found to be well-tolerated at likely clinical doses, and no serious adverse events were seen in healthy overweight and obese adults.
Study MSI-1436C-101, the first trodusquemine Phase I trial, is a double-blind, randomized, placebo-controlled, single-group assignment safety study with seven subjects per group enrolled in sequential dose groups of healthy overweight or obese adult male and female volunteers who have a body mass index (BMI) of 27-40. In this trial, the pharmacokinetic profile of trodusquemine showed a consistent pattern with minimal subject-to-subject variability and linearity across the range of doses studied.
Genaera plans to conduct its second ascending single dose Phase I clinical trial (Study MSI-1436C-103) of trodusquemine in obese type 2 diabetics. The trial will evaluate the PK and safety of trodusquemine in this population as well as provide the first opportunity to study short-term glucose control indices, glucose tolerance and insulin sensitivity.
Michael Gast, executive vice president and chief medical officer of Genaera, said: “The safety, tolerability and pharmacokinetics of trodusquemine observed in this study are consistent with the results achieved in preclinical studies. We look forward to advancing trodusquemine through the clinic in our next set of clinical trials as we study patients with both obesity and type 2 diabetes so that we may potentially provide a monotherapy option for patients afflicted by these disorders.”