Phase III trial of Gimoti (metoclopramide nasal) fails to meet endpoint but shows some benefits in recurrent diabetic gastroparesis- Evoke Pharma
Evoke Pharma has provided additional data from the Phase III trial of Gimoti (metoclopramide nasal) for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Although the Phase III trial failed to reach its primary endpoint, data also demonstrated that patients with moderate to severe symptoms, which included 105 of the 205 patients (51%) enrolled in the study, responded statistically significantly better when treated with Gimoti than those treated with placebo at multiple time points in the Intent-to-Treat (ITT) and Per Protocol populations. There were also clinically and statistically significant improvements in nausea and abdominal pain, which are two of the more severe and debilitating symptoms of gastroparesis. These results in patients with moderate to severe symptoms are consistent with the FDA guidance on the clinical evaluation of drugs for the treatment of gastroparesis issued in July 2015.
Phase III safety data revealed no significant adverse effects and were consistent with favorable results from previous Gimoti studies. In particular, there were no adverse events of special interest, such as the central nervous system effects observed with oral and parenteral metoclopramide.
Related news and insights
Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH])
Merck KGaA, a leading science and technology company, announced that its two Phase III EVOLUTION clinical trials (evolution RMS 1 and evolution RMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (Aubagio) (0.11 vs. 0.11 in evolution RMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolution RMS 2, p=NS in both trials)