Prifemilast
// Prifemilast
Overview
// Prifemilast
Clinical and Nonclinical Studies
vTv conducted one single- and two multiple-ascending-dose studies in healthy participants in the United States, all of which showed a favorable safety profile, with little to no gastrointestinal adverse events, such as nausea, vomiting, or diarrhea.
Newsoara has completed one Phase 3 study in China and is currently conducting a second Phase 3 study in support of a contemplated new drug application. cAMPfield is planning global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn’s disease.
Prifemilast has shown potent inhibition of interleukin-23 (IL-23) and tumor necrosis factor alpha (TNF-α) production in vitro and in vivo, as well as therapeutic activity in several animal models of inflammation. In addition, prifemilast showed target engagement ex vivo.
Mechanism of Action
PDE4 inhibitors increase intracellular cyclic adenosine monophosphate (AMP) levels, resulting in broad anti-inflammatory effects. However, the therapeutic potential of PDE4 inhibitors has historically been limited by dose-limiting adverse events, including nausea and emesis. Preclinical and clinical data to date suggest Prifemilast may avoid some of the gastrointestinal side effects (e.g., nausea, vomiting, diarrhea) commonly associated with other PDE4 inhibitors.