Evoke Pharma is taking a hit in the markets after announcing a Phase 3 trial on a gastrointestinal drug for diabetes patients failed to meet its goals.
In early trading Monday, Evoke’s (NASDAQ: [[ticker:EVOK]]) stock price was down 72 percent to $3.02 per share as of 11:30 a.m. in New York. The company is developing a nasal formulation of metoclopramide, an already-approved treatment for digestive pain and other symptoms related to the stomach being unable to empty its contents. Metoclopramide is currently available in oral and intravenous forms.
Evoke’s late-stage study failed to show a significant benefit to the drug, EVK-001, versus placebo at all 41 of the sites that tested it nationally. In about one-third of the sites (13 out of 41), patients in the trial who took placebo reported an improvement in symptomatic diabetic gastroparesis.
Patients who have the stomach condition, which is also called delayed gastric emptying, have trouble emptying food from the stomach into the small intestine, according to the National Institute of Diabetes and Digestive Kidney Diseases. The condition is also associated with abdominal pain and bloating, and lack of appetite and can be can be caused by diabetes, which damages the vagus nerve regulating digestive functions.
Solana Beach, CA-based Evoke plans to conduct further analysis of the study, which examined 205 patients nationally over four weeks, and used a survey methodology to derive a score on the frequency and severity of the signs and symptoms of the condition. Evoke didn’t reveal any further plans.
Others have had trouble developing a treatment for diabetic gastroparesis, too. In 2012, then-Research Triangle Park, NC-based Tranzyme Pharma, which was acquired by Ocera Therapeutics (NASDAQ: [[ticker:OCRX]]) in a reverse merger in 2013, stopped work on its experimental treatment for the condition after the company’s pill was outperformed by a placebo in a mid-stage clinical trial.
But the Evoke news could open the door to the owner of relamorelin (also called RM-131), another drug being developed for diabetic gastroparesis. Originally developed by Rhythm Pharmaceuticals, the drug aimed to cut patients’ gastric emptying time—how long it takes for the stomach to flush out food—and showed positive results during a Phase 2 trial in May 2014. Later that year, Rhythm sold the candidate to Actavis, the Irish drugmaker formerly known as Watson Pharmaceuticals, which started a Phase 2b trial last year. Actavis is now known as Allergan (NYSE: [[ticker:AGN]]), adopting the name following its acquisition of that company last year.
