Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GR-MD-02 · 5 trials · 7 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.
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. |
| 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. |
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 being studied for several conditions, including psoriasis, melanoma, non-alcoholic steatohepatitis (NASH), and portal hypertension. It is developed by Galectin Therapeutics Inc. (GALT) and is currently in clinical development, with completed trials in these indications.
GR-MD-02 is a small molecule that targets galectin-3, a protein involved in fibrosis and inflammation. By inhibiting galectin-3, it aims to reduce fibrotic tissue formation and inflammatory responses, which are relevant to conditions like NASH and psoriasis. This mechanism is being evaluated in clinical trials.
GR-MD-02 is developed by Galectin Therapeutics Inc., a biopharmaceutical company traded under the ticker GALT. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications, including NASH and cancer.
GR-MD-02 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, not yet approved by the FDA. The completed trials include a Phase 1 study in NASH, a Phase 2a study in psoriasis, and a Phase 2 study in liver fibrosis associated with NASH.
GR-MD-02 has been studied in several completed trials, including NCT01899859 (Phase 1 in NASH), NCT02407041 (Phase 2a in psoriasis), NCT02421094 (Phase 2 in NASH with advanced fibrosis), and NCT02575404 (Phase 1 in melanoma and other cancers). These trials have been completed.
GR-MD-02 is also known as belapectin, a name used in some clinical contexts. It is being developed by Galectin Therapeutics for conditions like NASH and fibrosis. The drug is distinct from other galectin inhibitors and is currently in clinical development.