Galectin Reports No Drug-Drug Interaction Between GR-MD-02 And Midazolam

(RTTNews) - Galectin Therapeutics Inc. (GALT) reported that in an open-label Phase 1 study with 8 mg/kg dose of GR-MD-02 and 2 mg/kg dose of midazolam there was no drug-drug interaction and no serious adverse events or drug-related adverse events were observed.

The company said that this study was required by the U.S. Food and Drug Administration or FDA and the primary objective was to determine if single or multiple intravenous or IV doses of GR-MD-02 affect the pharmacokinetics of midazolam. The secondary objective was to assess the safety and tolerability of GR-MD-02 when administered concomitantly with midazolam.

Galectin said the lack of a drug interaction in this study will permit the company to expand the number of patients eligible for its Phase 2 clinical trial. In addition, should GR-MD-02 be approved for marketing, the success of this study supports a broader patient population for the drug label.

The open-label Phase 1 study in normal healthy volunteer subjects tested a single dose of IV midazolam in the absence of GR-MD-02, following a single IV dose of GR-MD-02 and following three weekly IV doses of GR-MD-02. The four dosing periods were spaced one week apart, with midazolam PK determined in dosing periods one, two and four. A total of 17 subjects completed the study and met the primary endpoint of midazolam clearance when administered alone, compared with when administered with single and multiple doses of GR-MD-02.

With completion of this study, the company said it does not anticipate further drug-drug interaction studies will be required in the development of GR-MD-02.