Kadmon Holdings Inc (NASDAQ: KDMN), Inc announced that it publicized the data from a pivotal clinical trial of REZUROCK™ for the treatment of persistent graft versus host disease in the journal Blood yesterday. The data from the pivotal ROCKstar served as the basis for the company’s New Drug Application for REZUROCK for the graft versus host disease (cGVHD) treatment. It was permitted by the US Food and Drug Administration on July 16, 2021, for the treatment of adult and pediatric patients 12 and above ages with GVHD after the loss of two prior attempts of systemic therapy.
Corey Cutler’s Statement
Medical Doctor Corey Cutler, MD, MPH, FRCPC, said that Belumosudil is very beneficial in provoking response across all internal organs affected by cGVJD and is tolerated and well safe. He said it is fascinating to see the improvement of new interventions that can help affected people. Leveraging ROCK inhibition to handle fibrotic and immune components of GVHD is an initial step forward in treating this chronic disease.
Garland W. Waksal’s Statement
The outcomes from ROCKstar showcase the benefit that belum sudil can distribute to cGVHD patients by eliminating and reducing corticosteroid and calcineurin inhibitor doses, attaining developments in the quality of life, Harlan W. Walsall, MD, CEO and President of Kadmon said. Moreover, he adds that they are delighted by the recent FDA authorization of REZUROCK and look ahead to making the drug accessible to patients in the near term.
As per the previously reported data from ROCKstar, the Phase 2 randomized clinical trial of belumosudil enrolled 132 GVHD affections who had received two to five prior lines of therapy. It indicated an Overall Response Rate of 74% with 200mg once every day and 77% with 200 mg twice every day. Achieved reactions across patient subgroups, and detailed responses were observed in all organ systems along with lungs. Moreover, reactions were reliable, with a median duration of 54 weeks, demonstrating the total combined response periods for every patient.