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Adjunctive therapy to reduce AIC and insulin use - Phase 2 completed

Discussion in 'Research' started by fishface326, Jun 28, 2021.

  1. fishface326

    fishface326 Approved members

    Jun 5, 2018
    not earth-shattering results here, but it was a safety trial. Maybe if the get the dosage right, results would improve?

    REMD Biotherapeutics Announces Positive Top-Line Results in a Phase 2 Program of Lead Product Candidate Volagidemab in Patients with Type 1 Diabetes

    Results of Phase 2 Study Presented in oral presentation at the American Diabetes Association 81st Scientific Sessions

    June 28, 2021 10:15 AM Eastern Daylight Time
    CAMARILLO, Calif.--(BUSINESS WIRE)--REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing CoSci-REMD Bio (“Cosci‑REMD Bio”), today announced positive top-line results from a phase 2 clinical program of volagidemab (“Vola”) in patients with type 1 diabetes were presented at the American Diabetes Associations (ADA) 81st Scientific Sessions (ADA2021) as an oral presentation in the session entitled Novel Therapeutic Agents and Approaches.

    “Based on the results of this study, we are meeting with the FDA to discuss the design of the Phase 3 studies”

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    The program enrolled a total of 153 patients at eleven clinical sites in the United States in two randomized, placebo-controlled, double-blind trials to evaluate the safety, efficacy and pharmacodynamics of a once-weekly injection of volagidemab at 35 mg and 70 mg for 12 weeks in patients with type 1 diabetes who are currently receiving insulin treatment.

    Trial 2 results showed a statistically significant and clinically meaningful decrease in hemoglobin A1C and daily insulin use. In Trial 2, placebo-adjusted decrease in A1C was 0.53% and 0.49% and in patients with baseline A1C ≥7.5%, placebo-adjusted decrease in A1C was 0.89% and 0.51% for 35 mg and 70 mg volagidemab groups, respectively. In Trials 1 and 2 combined, there was a two-fold increase in the number of patients achieving Week 12 A1C of ≤7% in the volagidemab treatment arms versus placebo. No increases in hypoglycemia were observed with volagidemab treatment.

    Jeremy H. Pettus, M.D., Associate Professor of Medicine, Division of Endocrinology at UCSD and a principal investigator on the study presented the results at the virtual ADA 2021 Conference. “I have long been an advocate for exploring adjunctive therapies to insulin in patients with type 1 diabetes, and the results of this trial suggest that Vola is the most potent adjunctive therapy studied to date in terms of improvements in glycemic control. Therapies that improve glucose control and avoid hypoglycemia represent an important unmet need in the treatment of type 1 diabetes,” said Dr. Pettus. “Phase 3 clinical studies in type 1 diabetes patients are unfortunately rare, so I’m excited to see this compound moving forward and for the potential to participate in a Phase 3 study of volagidemab in this disease.”

    “Based on the results of this study, we are meeting with the FDA to discuss the design of the Phase 3 studies,” said Hai Yan, Ph.D., Chief Executive Officer at REMD Bio.

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