Silence Therapeutics SLN announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead candidate SLN124 for the treatment of polycythemia vera (PV).
SLN124 is designed to address a range of hematological diseases by targeting TMPRSS6 to increase endogenous hepcidin, the body's master regulator of iron balance and distribution.
SLN124 has demonstrated proof of mechanism and was well tolerated in a healthy volunteer study completed last year.
Craig Tooman, President and Chief Executive Officer, stated, ”The granting of Fast Track Designation represents an important recognition by the FDA of SLN124's potential to address a significant unmet need in the treatment of PV. We plan to leverage Fast Track to expedite our development path as we seek to provide an important new treatment option to those suffering from this very serious and chronic genetic disease."
The Company plans to commence a phase 1/2 study in patients with polycythemia vera (PV) this year.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Action : Silence Therapeutics shares closed Wednesday’s trading around 6 percent higher at $11.51
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