Gimoti, a drug formulated by Evoke Pharma Inc (NASDAQ:EVOK) to treat adult women suffering from recurrent and acute diabetic gastroparesis, has demonstrated positive results with regards to its potential. This was in the phase 3 trial of the drug.
Positive results
Despite the fact that the trial did not get to the primary endpoint, results of the trial showed that patients who exhibited symptoms ranging from the more severe ones to the moderate ones were able to get positive results when they took the drug. These positive results were noted with regards to abdominal pain and nausea. Of all the symptoms of gastroparesis, these two are considered the most debilitating and severe. These patients consisted 51 percent of the sample size.
The results of the effects of the drug on gastroparesis are consistent with the guidance from the Food and Drug Administration. On the clinical evaluation of drugs that are aimed at treating gastroparesis, the guidance that was issued in 2015 states that candidates for such trials should ideally be patients who have severe symptoms. This is for the purposes of optimizing the ability to demonstrate the potential of the drug to treat.
When the FDA guidance was being issued, the phase three trial of Gimoti had already been underway for a period of more than 12 months. While the results of the overall test were insignificant, the ones that were described in the guidance were. What made the efficacy of the overall results seem not significant is the fact that they included all the patients including those who showed mild symptoms and who responded positively to the placebo.
No adverse effects
Additionally, results from phase 3 of the trial also demonstrated no adverse effects on the patients who participated in the exercise. This included no adverse effects being experienced in the central nervous system.
“The consistently favorable safety profile of Gimoti among patients treated in our clinical trials and the benefits we have demonstrated, indicate that Gimoti can have a positive impact on the lives of these patients,” said the president and chief executive officer of Evoke Pharma, Dave Gonyer.
THE MORNING REPORT
Start your workday the right way with the news that matters most.
Your information is 100% secure with us and will never be shared Disclaimer & Privacy Policy
In Thursday’s trading, Evoke Pharma rose by 5.95% to close the day at $2.85 a share.
