Galectin Therapeutics Inc (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, reports 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. This study was required by the U.S. Food and Drug Administration (FDA) and the primary objective was to determine if single or multiple intravenous (IV) doses of GR-MD-02 affect the pharmacokinetics (PK) of midazolam. The secondary objective was to assess the safety and tolerability of GR-MD-02 when administered concomitantly with midazolam.
The lack of a drug interaction in this study will permit Galectin 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 success of this study is important to the advancement of GR-MD-02 as a treatment for non-alcoholic steatohepatitis (NASH) with fibrosis and/or cirrhosis because midazolam is widely used in clinical practice for mild, conscious sedation. Importantly, midazolam provides a good model for many other commonly used drugs that are metabolized by the CYP3A4 enzyme system, to which patients with liver disease might be exposed to for a variety of clinical indications,” said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. “We are very pleased to find no pharmacokinetic issues with GR-MD-02 and midazolam following single and multiple doses of both drugs. The rigorous conduct of this study was a requirement by the FDA and overcomes one more important hurdle in our efforts to bring a drug to address the needs of a growing number of patients who develop NASH, and subsequently progress to liver fibrosis and cirrhosis. ”
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. Drug to drug interaction studies are an integral part of understanding how a drug will affect patients who are also on other drugs. With completion of this study, the company does not anticipate further drug-drug interaction studies will be required in the development of GR-MD-02.
Dr. Traber added, “We are preparing to begin patient screening for our Phase 2 program in the coming weeks, which consists of a study in patients with NASH cirrhosis and a study in NASH patients with advanced fibrosis, but not cirrhosis. It should be noted as we embark on the next steps of our development strategy that Galectin has significantly invested in the chemical and pharmaceutical development of our compound, has implemented analytical methods to meet FDA requirements and is continually generating the necessary data to adequately characterize our drug compound. When a new chemical entity is chosen and defined as a potential drug candidate, the drug must be fully characterized. This drug characterization is necessary to understand the behavior of the drug, in solid state (drug substance) as well as in solution (drug product). Our working relationships with academic institutions and commercial analytical organizations with expertise in carbohydrate chemistry and analytical characterization of complex carbohydrate molecules helps to assure that our products are adequately characterized using the latest available technologies.” (Original Source)
Shares of Galectin Therapeutics closed yesterday at $2.63 . GALT has a 1-year high of $16.55 and a 1-year low of $2.61. The stock’s 50-day moving average is $3.21 and its 200-day moving average is $3.71.
On the ratings front, MLV & Co. analyst Vernon Bernardino reiterated a Buy rating on GALT, with a price target of $16, in a report issued on March 19. The current price target represents a potential upside of 508.4% from where the stock is currently trading.
According to TipRanks.com, Bernardino has a total average return of -13.4%, a 28.1% success rate, and is ranked #3564 out of 3602 analysts.
Galectin Therapeutics Inc is a clinical stage biopharmaceutical company. The Company is engaged in drug research and development to create new therapies for fibrotic disease and cancer.