Evoke Pharma Inc (NASDAQ:EVOK)’s shares are up 35% in pre-market trading today after closing 2.48% higher in the previous trading day.
The stock gained by double digits in pre-marketing trading after the specialty pharmaceutical firm focused on treatments for gastrointestinal (GI) diseases, provided additional data from the Phase 3 trial of Gimoti, its nasal delivery of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Although the Phase 3 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.
Phase 3 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 (CNS) effects observed with oral and parenteral metoclopramide.
There have been no reports of tardive dyskinesia among the 1,311 exposed healthy volunteers and patients over the clinical development program.
“As our discussions with the FDA progressed over the past few months, we have continued to analyze data from our Phase 3 trial of Gimoti. These additional analyses have provided us with important insights regarding the efficacy of Gimoti in patients with varying levels of symptom severity, despite not reaching the trial’s primary endpoint,” said Dave Gonyer, R.Ph., President and CEO.
The trial was a U.S. multicenter, randomized, double-blind, placebo-controlled, parallel‑group study of the efficacy and safety of Gimoti compared to placebo in adult female subjects with symptomatic diabetic gastroparesis and delayed gastric emptying. – BusinessNewsAsia.com