Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as galactoarabino-rhamnogalacturonate, GR-MD-02
belapectin · 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 ...
Belapectin is an investigational small molecule developed by Galectin Therapeutics Inc. (ticker GALT) for hepatic impairment. It is a galectin-3 inhibitor and has been studied in a Phase 1 clinical trial. Belapectin is not approved and remains in clinical development.
Belapectin is being developed for hepatic impairment, a condition of reduced liver function. The only clinical trial of belapectin listed was conducted in adults with hepatic impairment, including healthy volunteers, in the United States. It is investigational and has not been approved for any use.
Belapectin targets LGALS3, the gene encoding galectin-3, and acts as an inhibitor of this target. By inhibiting galectin-3, belapectin is designed to interfere with galectin-3 mediated biological activity. Galectin-3 is a beta-galactoside binding lectin involved in fibrosis and inflammation.
Belapectin is developed by Galectin Therapeutics Inc., a company whose ticker symbol is GALT. Galectin Therapeutics is the sponsor of the belapectin clinical program, including the Phase 1 trial in hepatic impairment.
Belapectin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Belapectin is investigational and has not been approved by the FDA or any regulatory authority.
Belapectin has been studied in one completed Phase 1 trial, NCT04332432, titled GT-032 Belapectin Hepatic Impairment. The trial enrolled 38 adults aged 18 years and older, included both sexes and healthy volunteers, and used an active-controlled design in the United States.