Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Galactoarabino-rhamnogalactouronate, galactoarabino-rhamnogalacturonate, galactoarabino-rhamnogalaturonate, belapectin
GR-MD-02 · 6 trials · 8 indications
The primary endpoint will be the number of participants with PASI-75, or a 75% improvement from baseline (day 1, prior to first infusion) in PASI score as assessed at the 30 day follow up visit.
Difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS). LiverMultiScan is CE marked as a class IIa medical device. Corrected T1 (cT1) is a Magnetic Resonance (MR) relaxation parameter/measure from the device.The measure cT1 can be compared across different Magnetic Resonance Imaging (MRI) systems and sites. It is an emerging biomarker for rapid quantification of hepatic fibro-inflammatory disease. In unhealthy tissue, such as in inflamed and fibrotic tissues, measures result in longer cT1-relaxation.
Change in Portal Pressure at Year 1 from Baseline
Patients are seen in clinic 7 times over 85 days. At each visit, a research nurse performs a toxicity check. Patients have 5 physical exams during the 85-day period.
Statistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.
Statistical comparison of the pharmacokinetic AUC0-t parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration.
Statistical comparison of the pharmacokinetic Cmax parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. Cmax = maximum observed concentration
Statistical comparison of the pharmacokinetic t1/2 parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. t1/2 = terminal elimination half-life.
The primary objective of this study is to characterize the safety, which includes the tolerability and dose-limiting toxicity (DLT), for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis. Specifically, this measure will be assessed by number of subjects experiencing treatment emergent adverse events indicative of DLT.
| Arm | Type | Description |
|---|---|---|
| GR-MD-02 | EXPERIMENTAL | active arm |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| 2 mg/kg GR MD 02 | ACTIVE_COMPARATOR | GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions |
| 8 mg/kg GR MD 02 | ACTIVE_COMPARATOR | GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions |
| 2 mg/kg GR-MD-02 | EXPERIMENTAL | 2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 4 mg/kg GR-MD-02 | EXPERIMENTAL | 4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 8 mg/kg GR-MD-02 | EXPERIMENTAL | 8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 4 mg/kg GR-MD-02 17 Cycles Maximum | EXPERIMENTAL | 4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles. |
| Group 1 | ACTIVE_COMPARATOR | 16 matched healthy subjects with normal hepatic function |
| Group 2 | ACTIVE_COMPARATOR | 8 subjects with mild hepatic impairment (Child-Pugh Class A \[4 x subjects with a score of 5 and 4 x subjects with a score of 6\]) |
| Group 3 | ACTIVE_COMPARATOR | 8 subjects with moderate hepatic impairment (Child-Pugh Class B \[score of 7 to 9\]) |
| Group 4 | ACTIVE_COMPARATOR | 8 subjects with severe hepatic impairment (Child-Pugh Class C \[score of 10 to 14\]). |
| Cohort 1 | ACTIVE_COMPARATOR | Patient receives dose of GR-MD-02 or placebo |
| Cohort 2 | ACTIVE_COMPARATOR | Patient receives dose of GR-MD-02 or Placebo |
| Cohort 3 | ACTIVE_COMPARATOR | Patient receives dose of GR-MD-02 or placebo |
| Name | Type | Description |
|---|---|---|
| GR-MD-02 | DRUG | IV infusion |
| Placebo | DRUG | Placebo |
| Pembrolizumab | DRUG | Patients will receive five 200mg doses of pembrolizumab intravenously over 85 days. After 85 days, patients may continue to receive pembrolizumab every 3 weeks if clinical benefit is noted. |
| belapectin | DRUG | intravenous |
Inclusion Criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements. 2. Is between the ages of 18 ...
GR-MD-02 is an investigational small molecule developed by Galectin Therapeutics Inc. (ticker: GALT). It has been studied in clinical trials for liver fibrosis and portal hypertension in patients with NASH cirrhosis, nonalcoholic steatohepatitis with advanced fibrosis, psoriasis, and in combination with pembrolizumab for melanoma and other cancers. It is not approved for any indication.
GR-MD-02 targets galectin-3, a protein involved in fibrosis and inflammation. By binding to galectin-3, the drug is designed to interfere with pathways that drive scar tissue formation in the liver and other organs. This mechanism underlies its investigation in NASH cirrhosis, portal hypertension, and psoriasis.
GR-MD-02 is being developed by Galectin Therapeutics Inc., a biopharmaceutical company that trades under the ticker symbol GALT. The company has sponsored multiple clinical trials of GR-MD-02 in liver disease and other conditions.
GR-MD-02 has completed Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA for any indication. The completed studies evaluated the drug in NASH cirrhosis, nonalcoholic steatohepatitis with advanced fibrosis, psoriasis, and in combination with pembrolizumab in certain cancers.
GR-MD-02 has been studied in several completed trials, including NCT02462967, a Phase 2 trial in liver fibrosis and portal hypertension in NASH cirrhosis with 162 patients; NCT02421094, a Phase 2 trial in NASH with advanced fibrosis; NCT02407041, a Phase 2a trial in psoriasis; and NCT02575404, a Phase 1 trial in melanoma and other cancers.