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Evoke Diabetic Gastroparesis Drug Gimoti Positive in Phase III

Zacks Equity Research

Evoke Pharma, Inc. EVOK announced additional data from a phase III trial on Gimoti (nasal delivery), a novel formulation of its marketed drug, metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

The stock was up 29% following the announcement. The phase III study, conducted in Jul 2016, compared the efficacy and safety of Gimoti with placebo in adult women with symptomatic diabetic gastroparesis and delayed gastric emptying.

Although the phase III study was unable to achieve the primary endpoint, data demonstrated that 51% of patients with moderate-to-severe symptoms witnessed a statistically significant benefit when treated with Gimoti compared with placebo at multiple time points in the Intent-to-Treat (ITT) and Per Protocol populations.

Data also showed that there were clinically and statistically significant improvements in nausea and abdominal pain – two severe and debilitating symptoms of gastroparesis.

Evoke’s three-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical-Generic Drugs industry. Specifically, the company gained 22.9%, while the industry lost 9.8%.

In Sep 2016, the company completed a pre-New Drug Application (NDA) meeting with the FDA.  The purpose of the meeting was to discuss a proposed NDA, and confirm various regulatory, chemistry, manufacturing, and control, non-clinical requirements for a regulatory submission. At the meeting, the FDA reviewed a portion of data that was being prepared for the filing, based on which, it was determined that the available data would be sufficient for an NDA submission.

Apart from the phase III trial, the company has conducted a companion clinical trial on Gimoti to assess its safety and efficacy in male patients with symptoms associated with acute and recurrent diabetic gastroparesis. The companion trial was initiated in May 2014 and the design was the same as the phase III trial in women. The trial was requested by the FDA to confirm the results of a phase IIb trial results to capture additional safety data in men. However, results of the study were not relevant for the submission of the NDA for the indication in women.

However in Nov 2016, the company revealed that Gimoti failed to demonstrate statistically significant efficacy in men. The company also announced that even if the study was fully enrolled, results would not differ. Nevertheless, results showed that the safety profile for Gimoti was favorable compared with placebo and the drug was generally well tolerated, as  anticipated by the company at the commencement of the trial and analysis of prior phase IIb data.

We note that metoclopramide is the only approved treatment for gastroparesis in the U.S. and is currently available only in the oral and intravenous forms. On the flip side, Evoke depends entirely on Gimoti for its top line. Naturally, the product’s recent failure to achieve the primary endpoint of symptom improvement in the phase III clinical trial on female patients with diabetic gastroparesis was disappointing. As a result, the company has been unable to gain long-term visibility on a path forward with regard to the candidate.
Per the company’s press release, patients suffering from moderate-to-severe forms of gastroparesis, who do not respond to treatment with oral metoclopramide, often require hospitalization, which unlocks significant market opportunity for Gimoti.



Zacks Rank & Key Picks

Evoke currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Arena Pharmaceuticals, Inc. ARNA, Cambrex Corporation CBM and Kamada Ltd. KMDA. While Cambrex sports a Zacks Rank #1 (Strong Buy), Arena Pharma and Kamada carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Arena’s loss estimates declined from 36 cents to 34 cents for 2016 and from 33 cents to 32 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.43%.

Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 8.6% in the past one month.

Kamada’s earnings estimates widened from 6 cents to 10 cents for 2016 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 31.25%.

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