Evoke Pharma ($EVOK) saw its shares nose-dive by more 75% after it disclosed that a Phase III study for its nasal formulation of metoclopramide to treat diabetic gastroparesis symptoms in adult women failed to meet its primary endpoint.
The topline data were a bit surprising given that oral and intravenous metoclopramide are already FDA-approved and the drug has been in use to treat gastroparesis for decades. The micro-cap had been trading up this year in advance of the trial data--but saw its roughly $80 million market cap slashed to $20 million and fell to close to 52-week lows.
The company hasn’t abandoned the program yet--it’s looking at the data more closely. It said that 28 out of 41 sites showed statistically significant benefit for its EVK-001, while the remaining 13 sites had statistically significant benefit for placebo. It will examine the full data to try to understand these results.
"The topline results are unexpected and an anomaly, given that metoclopramide has been approved and used for treating diabetic gastroparesis for more than 35 years. Additionally, EVK-001 provides predictable absorption of metoclopramide as seen in our prior trials," said Evoke President and CEO Dave Gonyer in a statement. “We continue to believe that EVK-001 is a promising treatment option for patients who currently rely on oral drugs to treat their symptoms of gastroparesis. Our analysis will continue as the remainder of the data become available and an update will be provided when we have more clarity on our steps ahead."
The primary endpoint of the trial was symptom improvement at Week 4 based on the company’s patient reported outcome instrument. The study was in 205 adult women with diabetic gastroparesis who received EVK-001 or placebo four times daily for four weeks. Diabetic gastroparesis is a gastrointestinal disorder in which the stomach takes too long to empty, causing heartburn, nausea and vomiting.
Evoke went public in the fall of 2013 with a $25 million IPO; it was backed by venture investors including Domain Associates.
EVK-001 is the Solano Beach, CA-based specialty pharma’s only candidate. Evoke only had $6.1 million in cash at the end of the last quarter, with an operating loss that quarter of $3.2 million.
- here is the release
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