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Evoke (EVOK) Stock Down on Poor Phase III EVK-001 Data

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Evoke Pharma, Inc.’s (EVOK - Free Report) shares plunged 73.1% after the company announced unfavorable top-line data from a phase III study on its lead candidate, EVK-001, for the treatment of female patients with symptomatic diabetic gastroparesis.

EVK-001 is a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Patients were randomized to receive EVK-001 or placebo four times daily for four weeks.

Data revealed that EVK-001 failed to achieve the primary endpoint of symptom improvement at the end of four weeks. Preliminary review of the top-line data in all study sites demonstrated similar improvement in both the EVK-001 and placebo groups at the end of four weeks, as measured by the total symptom score and individual scores for each of the signs and symptoms. These results were, however, not consistent across the study sites.

On the other hand, the safety results were found to be in line with findings from the previous studies on the candidate, which showed that the nasal formulation of metoclopramide had a favorable safety profile. Also, EVK-001 was well tolerated in healthy volunteers and patients with diabetic gastroparesis.

The company stated that it intends to conduct additional analyses to further understand the discrepant results once complete datasets and pharmacokinetics (PK) data are available.

Gastroparesis is estimated to be prevalent in up to 4% of the total U.S. population. Currently, there are 2 million to 3 million patients being treated for the disease in the U.S., apart from over 10 million that suffer without treatment.

With limited treatment options currently available, there is urgent need for new treatments in this field.

Going forward, we expect investors to focus on further updates on the company’s lead candidate.

Evoke Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Nektar Therapeutics (NKTR - Free Report) , CytRx Corporation and Innoviva, Inc. (INVA - Free Report) . Each of these stock sports a Zacks Rank #1 (Strong Buy).

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