Icagen says the U.S. Food and Drug Administration (FDA) has given fast track designations to ICA-17043, currently in Phase II clinical trials for the treatment of sickle cell anemia.

The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Sickle cell anemia is a disease affecting predominantly those of African origin, and several million patients worldwide. The disease is caused by a single point mutation in the genetic sequence coding for hemoglobin leading to the formation of “sickle” shaped cells that obstruct normal blood flow with consequent tissue injury.

Icagen says its ICA-17043 represents a novel approach to the treatment of sickle cell anemia by targeting a specific ion channel, known as the Gardos channel, located on the membrane of red blood cells. In patients with sickle cell anemia, this channel has been shown to play an important role in the dehydration of red blood cells. By blocking this channel, ICA-17043 is anticipated to prevent this cellular dehydration, thereby reducing the tendency of the red blood cells to become sickle-shaped.

Icagen is currently studying ICA-17043 in a randomized, double-blind, placebo-controlled Phase II trial, which is enrolling patients in 15 centers across the country. A variety of laboratory and clinical endpoints are being evaluated, including changes in certain hematologic parameters and several measures of pain.