Synergy Pharmaceuticals Inc (NASDAQ:SGYP) recently announced results of its first phase 3 trial of Plecanatide among those patients who are suffering from constipation-accompanied irritable bowel syndrome. The clinical trials of this first round of phase 3 clinical trials turned positive, the company said. In this round, Synergy checked the safety and efficacy of Plecanatide. This is the medication of company that is primarily an orally-administered compound to be taken once a day.
The study results turn positive
The first out of two trial for Phase 3 of this medication was conducted among 1,135 adult patients suffering from irritable bowel syndrome along with constipation. The company explained that in prelim analysis, the 3 mg and 6 mg doses of new tested drug showed the satisfactory significance. The test was conducted among patients considered to be “Overall Responders.”
The side effect as the company says, which turned out to be the most common of all, was diarrhea. About 3.2% patients showed the symptoms of this event when administered with 3 mg dose. The same event occurred in 3.7% of the patients who received 6 mg dose.
There were 4 patients during the trial who also witnessed serious side effects. The withdrawal symptoms occurred in 1.9% patients for 3 mg dose and 1.8% patients for 6 mg dosage.
New treatment, positive outlook and another feather on Synergy’s cap
Company’s CEO & Chairman, Dr. Gary S. Jacob said that Synergy Pharmaceuticals Inc. is happy to see the positivity of these results. It indicated he stated, that Plecanatide is in a strong position and represents a new option for the patients amongst whom the constipation-accompanied irritable bowel syndrome is common.
The company is now planning to check the results of second phase 3 trial with Plecanatide. The positive results are putting the company in a stronger position from where it can also pitch Plecanatide for positive chronic idiopathic constipation (CIC) treatment in front of FDA. The company has already said that the same treatment is put forth USFDA for chronic idiopathic constipation, expecting positive outcome from the administration.