Imara announced encouraging results from the Phase2a clinical trial on IMR-687 in 93 patients with sickle cell disease (SCD) at the EHA2021 Virtual Congress, June 9-17, 2021. IMR-687 is an oral disease-modifying treatment for SCD and β-thalassaemia that acts to reactivate foetal haemoglobin (HbF) by blocking a cGMP-selective phosphodiesterase, called PDE9.
Clinical data reported that treatment with IMR-687 at 200 mg was safe and well-tolerated as a monotherapy or in combination with hydroxyurea and, did not have treatment-related serious adverse events (mainly headache, nausea, and abdominal pain). The treatment sucessfully reduced the average annualized rate of vaso-occlusive crises (VOCs) by 40% and increased the time to first VOC by almost 2-fold compared with placebo. In addition, more than one-third (36%) of patients with SCD achieved absolute HbF increases of more than 3% at month eight with minimal change in total haemoglobin. Based on these findings, Imara launched the Ardent Phase2b clinical trial to assess the safety and clinical efficacy of IMR-687 at a higher daily dose of up to 400 mg in SCD. This trial is currently being conducted across 50 sites in 13 countries, including Africa, and patient enrollment is marked as complete. The company is currently enrolling patients for its Forte Phase 2b clinical trial of IMR-687 for β-thalassaemia. Imara recently announced that the United States Adopted Names (USAN) Council adopted “tovinontrine” as the generic name for IMR-687. For more information: ASH news, Imara press release-June, Imara press release-August