Galectin Therapeutics (GALT) Tops Q3 EPS by 10c

Galectin Therapeutics (NASDAQ: GALT) reported Q3 EPS of ($0.17), $0.10 better than the analyst estimate of ($0.27).

The Company also provided an update on its development program.

According to Peter Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics, "In the past three months, we have continued progress in our development program. We were pleased to have data from cohorts 1 and 2, as well as, interim data from nine completed patients from cohort 3 of our Phase 1 clinical trial of GR-MD-02, our patent-protected proprietary galectin inhibitor, in patients with NASH with advanced fibrosis presented at the American Association for the Study of Liver Diseases meeting (The Liver Meeting) on November 9, 2014. We were gratified to have the data presented at this forum, which represents the largest and most prestigious liver meeting in the world, attended by thousands of physicians, scientists and researchers from around the globe."

"The presentation at AASLD's The Liver Meeting was delivered by Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston," continued Dr. Traber. "Dr. Harrison represented an outstanding group of principal investigators at leading medical institutions in the U.S., many of whom have authored seminal publications in liver disease, and NASH in particular. For example, Dr. Arun Sanyal was the first author on the PIVENS clinical trial (N Engl J Med 2010;362:1675-85), which represents a model for the conduct of clinical trials in NASH. Dr. Brent Neuschwander-Tetri was the first author on the recently published FLINT clinical trial (Lancet 2014 doi:10.1016/S0140-6736(14)61933-4). These are only two examples of the many contributions made by this group to the science and clinical care of patients with NASH. Galectin Therapeutics is greatly appreciative of all their efforts related to this Phase 1 clinical trial."

The overall objective of the Phase 1 study was to evaluate safety and pharmacokinetics of GR-MD-02 to provide information and support to design a Phase 2 clinical program to assess efficacy of GR-MD-02 in patients with NASH with advanced fibrosis and cirrhosis. Specifically, this Phase 1 first-in-man study evaluated the safety, tolerability, and pharmacokinetics and explored potential serum biomarkers for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis.

The information presented by Dr. Harrison, as provided in the presentation released simultaneously with this announcement of the Company's third quarter financial results, covered a number of important areas:

Pre-clinical data. Published pre-clinical data on efficacy of GR-MD-02 was reviewed as a basis for the human clinical development program. The positive effect of GR-MD-02 on advanced fibrosis and cirrhosis in animal models was highlighted.
Cohorts 1, 2 and 3. Previously-reported results from the ongoing Phase 1 clinical trial including completed cohorts 1 and 2 were presented and, for the first time, interim data from completed patients from cohort 3. In the three-cohort design, eight patients (6 active drug and 2 placebo) completed cohort 1 at the 2 mg/kg dosage; nine patients (7 active drug and 2 placebo) completed cohort 2 at the 4 mg/kg dosage; and nine patients (6 active drug and 3 placebo) have so far completed cohort 3 at the 8 mg/kg dosage. Therefore, there was a similar number of patients from each of the cohorts for comparison purposes.
Phase 1 results. The data showed that administration of 2, 4 and 8 mg/kg lean body weight of GR-MD-02 intravenously for four doses over 6 weeks was safe and well tolerated. Thus, the primary endpoint of the study has been met. There were no serious adverse events reported in any of the three cohorts and the mild (grade 1) adverse events possibly related to study drug were found in 3 placebo patients and only 2 patients receiving active drug.
Phase 1 pharmacokinetics. In cohorts 1 and 2, pharmacokinetic data demonstrated a proportional increase in total drug exposure with doubling of the dose of GR-MD-02 with no accumulation after four doses. In newly released data from cohort 3, Dr. Harrison reported that pharmacokinetic analysis of GR-MD-02 plasma levels for the 8 mg/kg dose provides drug coverage in the upper portion of the targeted therapeutic range derived from NASH animal model studies.
Phase 1 biomarkers. While there are no validated serum biomarkers for evaluation of potential therapeutic changes over time in NASH or fibrosis, a panel of serum tests were evaluated to explore potential biomarkers for use in future studies. For a test to be useful for evaluating disease activity, it is necessary that the tests have reasonably low variability over time in patients that are treated with placebo. Unfortunately, most of the putative biomarkers showed high variability within the same individual in placebo and GR-MD-02 patients, rendering them not useful as reliable biomarkers in this short-term clinical trial. Earlier results in this patient population that suggested changes in certain biomarkers were not evident with increased numbers of placebo patients for comparison after cohort 3.
FibroTest®. One test did indicate that there was an effect of the drug on a disease associated biomarker. FibroTest®, a composite score that has been correlated with the extent of liver fibrosis, was significantly reduced by GR-MD-02 treatment in cohort 3. This change was attributable to a reduction in serum alpha-2 macroglobulin, a protein long studied in liver disease. This reduction was only evident at the 8 mg/kg dose, and indicates some dose-dependent pharmacodynamic effect of GR-MD-02.

"Based on the robust pre-clinical efficacy and positive safety, tolerability and pharmacokinetics in the Phase 1 clinical trial and a pharmacodynamic effect, the Company is in a position to design a strong Phase 2 clinical trial to assess potential surrogate endpoints that are closely associated with clinical-related outcomes in patients with cirrhosis, including hepatic venous pressure gradient (HVPG) and morphometric analysis of collagen on liver biopsies," continued Dr. Traber. "To this end, the Company recently met with the U.S. Food and Drug Administration (FDA) to discuss a proposed design of a Phase 2 clinical trial and other activities in support of a Phase 2 trial. The company has determined its Phase 2 trial will be in NASH patients with cirrhosis with evaluation of portal hypertension (hepatic venous pressure gradient) as the primary endpoint and the amount of collagen as a key secondary endpoint. Further details of the clinical trial will be announced prior to initiation. We are finalizing the clinical plans and expect to begin a Phase 2 clinical trial in the second quarter of 2015. We are extremely pleased with the progress of the GR-MD-02 development program and continue to believe firmly that a galectin inhibitor such as our GR-MD-02 has a potential role to play in treatment of liver fibrosis."

"Based on the positive results of the Phase 1 clinical trial, there is adequate data to proceed with a phase 2 program," noted Dr. Traber. "For this reason, we will terminate the enrollment of additional patients in the Phase 1 trial and complete the additional 4 patients that are currently undergoing treatment, providing a total of 13 patients in cohort 3."

Dr. Traber added, "We also significantly enhanced our patent portfolio recently with the issuance of U.S. Patent No. 8,828,971 entitled Galactose-Pronged Carbohydrate Compounds for the Treatment of Diabetic Nephropathy and Associated Disorders. Also, we received a notice of allowance for patent application number 13/573,442 titled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases." This patent covers composition and chemical structural claims for compounds that includes the Company's lead galectin inhibitor compound GR-MD-02 and will not expire until December 2031; and an additional notice of allowance which further broadens the Companies intellectual property protection for patent application number 14/456,644 titled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases" which amongst other items, covers processes of making our lead compound from a variety of various pectin sources and will not expire until 2031. Finally, we recently announced a significant addition to our board of directors in the election of Gilbert S. Omenn, M.D., Ph.D. Dr. Omenn's wealth of experience and knowledge will be an outstanding resource for the company."

"Following our announcement of the second cohort results of our Phase 1 clinical trial of GR-MD-02, a number of shareholder lawsuits were filed against Galectin Therapeutics and certain of its directors and officers alleging breaches of fiduciary duties and/or violations of the federal securities laws," noted Dr. Traber. "We dispute the allegations underlying these complaints, which are primarily based on misinterpretations of the GR-MD-02 Phase 1 second cohort results and erroneous allegations relating to Galectin Therapeutics' engagement of outside firms to promote the Company. We intend to vigorously defend against these allegations and claims and intend to seek dismissal of the litigation. We have filed motions requesting that the litigation be transferred from Nevada to Georgia, where the Company is headquartered. We expect that the costs we incur defending against this litigation will be covered by directors' and officers' liability insurance, subject to the applicable policy retention. For more information on the litigation, see our litigation disclosure in our September 30, 2014 Form 10-Q."

For earnings history and earnings-related data on Galectin Therapeutics (GALT) click here.

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