Results from a Phase 2 proof-of-concept study, Motion Sifnos, evaluating Vanda Pharmaceuticals’ (NASDAQ:VNDA) tradipitant for the treatment of motion sickness showed encouraging action in situations with a higher level of motion. The study, conducted on the Pacific Ocean in calm and rough conditions, recruited 126 people with prior histories of motion sickness.
Tradipitant failed to sufficiently separate from placebo in a calm sea environment, but demonstrated a statistically significant treatment benefit in rough seas. Specifically, 72% (n=13/18) of subjects in the control group vomited compared to 16% (n=3/19) in the treatment group (p=0.0009). The difference in a scale called Motion Sickness Severity Scale Worst Score was also statistically valid, 3.19 for the tradipitant group versus 4.57 for the control (p=0.0235). Both measures were the primary endpoints.
Tradipitant is a neurokinin-1 receptor antagonist, a class of drugs that is also used to treat chemotherapy-induced nausea and vomiting.
Phase 3 studies are next up. If all goes well, the company plans to file a U.S. marketing application in 2020.
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