- U.K.-based clinical-stage biotech Silence Therapeutics plc ( NASDAQ: SLN ) announced Thursday that the FDA granted Fast Track Designation to SLN124 as a treatment for polycythemia vera (PV), a type of blood cancer.
- SLN124, belonging to a drug class called short interfering ribonucleic acid (siRNA) therapeutics, is set to undergo a Phase 1/2 study in PV this year.
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
- If certain criteria are met, such programs will also be able to win the Accelerated Approval and Priority Review, enabling them to reach patients sooner.
- In a clinical trial last year, SLN124 indicated proof of mechanism and was well tolerated among healthy volunteers.
For further details see:
Silence Therapeutics wins FDA’s fast track status for blood cancer therapy