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Imara Announces First Patient Dosed in Forte Phase 2b Clinical Trial of IMR-687 in β-Thalassaemia

Imara Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of haemoglobin,  announced dosing of the first patient in the company’s Forte Phase 2b clinical trial of IMR-687 for patients with β-thalassaemia.

“There are currently no approved oral therapies to increase fetal haemoglobin in β-thalassaemia, a rare inherited red blood cell disorder which if left untreated, causes severe anemia, enlarged spleen, skeletal abnormalities, organ failure and early death,” said Dr Perla Eleftheriou, Consultant Hematologist in the Red Cell Hematology department at University College London Hospitals NHS Foundation Trust, Member of TIF’s Scientific Advisory Board, and national lead investigator in the UK on the Forte trial. “We believe there is a clear rationale to expand development of IMR-687 to include β-thalassaemia and we look forward to working alongside multiple clinical centers globally to advance IMR-687 in the Forte clinical trial.”

“Dosing of the first patient in the Forte Phase 2b clinical trial marks an important milestone for Imara as we begin clinical evaluation of IMR-687 for the first time in patients with β-thalassaemia,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “Multiple preclinical studies show that treatment with IMR-687 enhances both the maturation and production of red blood cells in β-thalassaemia and we are looking forward to advancing this potentially transformative oral therapy for patients.”

IMR-687 has already been granted Orphan Drug, Fast Track and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of β-thalassaemia.

The global, randomized, double-blind, placebo-controlled, multicenter Forte Phase 2b clinical trial will evaluate the safety and tolerability of IMR-687 in approximately 120 adult β-thalassaemia patients. Patient randomization will be stratified by transfusion dependence (TDT) or non-transfusion dependence (NTDT) and weight-based dosing will be employed to optimize drug exposure and tolerability.

For more information about the Forte trial, visit: https://www.clinicaltrials.gov/ct2/show/NCT04411082

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