Imara Inc. said that it has wrapped up enrollment of patients in the Ardent phase 2b clinical trial of IMR-687 (tovinontrine) for sickle cell disease.

According to the US-based clinical-stage biopharma company, IMR-687 is a potent small molecule inhibitor of PDE9.

Rahul Ballal — President and CEO of Imara, commenting on the Ardent phase 2b clinical trial, said: “We are pleased to achieve this important milestone for IMR-687.

“Furthermore, we are excited to have enrolled subjects from across the world, including in Africa, making this a truly global effort. We look forward to reporting interim data for the Ardent trial in the fourth quarter of this year and can now refine guidance and expect to report data from the primary analysis in the first quarter of 2022.”

The Ardent Phase 2b clinical trial will have nearly 99 adult patients with sickle cell disease in what will be a randomized, double-blind, placebo-controlled, multicenter study. The mid-stage trial will assess the safety and efficacy of IMR-687 to be administered daily once.

Patients in the Ardent clinical trial are randomly grouped to IMR-687 higher dose of 300mg or 400mg based on patient weight, a lower dose of the drug candidate at 200mg or 300mg, or placebo.

The Ardent Phase 2b clinical trial is being carried out at nearly 50 sites in 13 countries.

  Imara, IMR-687, PDE9, Rahul Ballal, Sickle Cell Disease, tovinontrine, USA