Type 1 Diabetes - January 2021
CAR-T Digest - August 2020
CAR-T Digest - August 2020
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Type 1 Diabetes - January 2021
REMD Biotherapeutics announced completion of enrollment and top-line results from Phase 2 trial of Volagidemab in patients with Type 1 Diabetes
07 Jan 2021
Volagidemab/ REMD-477 (Human IgG2 monoclonal antibody) – REMD Biotherapeutics/ Beijing CoSci-REMD Bio/ Amgen
- REMD Biotherapeutics completed enrollment and reported top-line results for the Phase 2 study of volagidemab in patients with T1D
- Trial details: NCT03117998; Phase 2; N= 150; in patients with Type 1 Diabetes mellitus; Volagidemab 35 mg vs 70 mg vs placebo; Primary outcomes: Daily insulin use; PCD: Jan’21; Recruiting; Location: US
- Part A: Unblinded continuous glucose monitoring (CGM) and inpatient stays
- Part B: Blinded CGM and no inpatient stays
- Results: (N= 150)
- Glycemic control: Volagidemab treated patients showed better improvement vs placebo
- Volagidemab can be an add-on therapy for the nearly 70% of people with T1D whose blood-sugar levels are not controlled by insulin alone
- The detailed data will be presented at an upcoming scientific conference
Volagidemab demonstrate better glycemic control in the Phase 2 study
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CI Scientists Remarks:
- REMD Biotherapeutics in licensed Volagidemab from Amgen in May 2013, and is developing the product along with its subsidiary Beijing CoSci-REMD Bio Med-Tech
- Volagidemab is a glucagon receptor antagonist that specifically binds to the glucagon receptor and blocks the action of glucagon thus keeping glycemic levels under control
- Volagidemab was initially evaluated at a single dose of 70 mg in Phase 1, in which it showed a 32% reduction in daily insulin use compared to placebo without any adverse events, to which company decided to evaluate the molecule at a half dose as well
- Results from Phase 1 clinical study of Volagidemab (N= 17)
- Reduced daily insulin use by 32% (4.2%, 60%) in Volagidemab treated group vs. placebo on Day 4 (p=0.027)
- Average daily continuous glucose monitoring was 19 mg/dL (6.2, 31; p=0.006), and 26 mg/dL (8.2, 45; p=0.008) lower in the Volagidemab group vs placebo group at Weeks 2 and 3 after treatment
- Glucose time-in-range (70-180 mg/dL) for Volagidemab was 9.5% (2.7%, 16%; p=0.009) and 13% (1.9%, 25%; 0=0.026) greater in the Volagidemab group than in the placebo group during Weeks 2 and 3 after treatment
- Volagidemab therapy was well tolerated and no episodes of severe hypoglycemia were noted
- REMD Biotherapeutics plans to conduct a global Phase 3 study for Volagidemab
– Tarun Raisinghani, CI Scientists