Imara Changes Primary Endpoint In Mid-Stage Sickle Cell Disease Trial

Imara Inc IMRA has announced a change to the primary endpoint for the Ardent Phase 2 trial of tovinontrine (IMR-687) in sickle cell disease.

• Imara is a biopharmaceutical company focused on therapeutics for rare inherited genetic disorders of hemoglobin.
• The change follows the recommendation from the FDA.
• Imara requested feedback from the FDA on the draft statistical analysis plan for the Ardent trial in which fetal hemoglobin (HbF) response was the primary endpoint.
• Secondary endpoints for the trial included annualized rate of vaso-occlusive crises (VOCs). 
• The FDA recommended that Imara change the primary endpoint to be the annualized rate of VOCs. 
• HbF response will continue to be evaluated as a key secondary endpoint. 
• The first review of data, including annualized VOC rate, will be conducted when all subjects have completed assessment at Week 24 and are planned for Q1 of 2022.
• Final data analysis from the Ardent trial remains on track for 2H of 2022. 
• Tovinontrine is a small molecule inhibitor of phosphodiesterase-9 (PDE9). 
• PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells.
• Related Link: Imara Raises $50M In Equity Funding To Support Development Of Sickle Cell Treatment Candidate.
• Price Action: IMRA shares are down 5.45% at $3.12 during the market session on the last check Monday.