The US Food and Drug Administration (FDA) has approved Sinfonia’s Investigational New Drug (IND) application for phase IIb studies in chronic sciatic pain with its lead compound SB0101. The Phase IIb trial builds on positive results obtained in a previous phase IIa trial in more than 150 patients where SB0101 demonstrated significant pain-lowering effects that lasted for several weeks. According to Dr. Olof Larsson, CSO, “The upcoming phase IIb study aims to include 200 patients with focus on optimizing the SB0101 therapy with respect to both the duration and the size of the pain lowering effect. Millions of people suffer from chronic sciatica but are inadequately treated by current analgesics. SB0101 represents a novel non-opioid drug with the potential to become a first-in-class effective treatment for sciatica. We are indeed very excited for the opportunity to take the next pivotal step with SB0101 towards phase III studies and commercialization“.
