Solid Draft Guidance Propels Evoke

By Chris Lange Published Sep 15, 11:40AM EDT

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Evoke Pharma Inc. (NASDAQ: EVOK) rose in the market on Tuesday on solid draft guidance for its Phase 3 study. The company announced that its Phase 3 clinical trial design for EVK-001 (metoclopramide nasal spray) is consistent with U.S. Food and Drug Administration (FDA) recommendations in the recently released draft guidance. The new draft guidance contains the FDA’s current thinking on trial design and study endpoints for drug development in the treatment of gastroparesis.

Ultimately the draft guidance provides recommendations for the design and endpoints used in gastroparesis clinical trials. It also outlines the FDA’s expectation that all sponsors will develop a well-defined and reliable PRO instrument consistent with a drug’s mechanism of action for use as the primary efficacy assessment tool in their clinical trials.

For some background on the company: Evoke is a specialty pharmaceutical focused primarily on the development of drugs to treat gastrointestinal disorders and diseases. The company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.

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Dave Gonyer, R.Ph, president and CEO of Evoke, said:

We are pleased to see the recommendations contained in the FDA’s Draft Guidance on gastroparesis are consistent with the feedback we received from the FDA for our Phase 3 study of EVK-001, which gives us further confidence in the design of our ongoing study. Our patented nasal delivery of metoclopramide for the treatment of symptoms associated with diabetic gastroparesis in women is one of only a few products in development for this disease. With a Phase 3 clinical trial design and endpoint that are consistent with the specific recommendations for protocol design, endpoint analysis and disease-specific concerns, we believe there is less regulatory risk with our development program for EVK-001 as it relates to this Draft Guidance.

R. Carlson, DMD, M.D., RAC, chief medical officer, commented as well:

We are further encouraged by specific statements made within the Draft Guidance that acknowledge patients with diabetic gastroparesis may have unpredictable gastric emptying and altered absorption of orally-administered hypoglycemic drugs. Importantly, we believe the FDA’s statements highlight the need for non-oral drugs like EVK-001 to treat the symptoms of gastroparesis. We believe that our intranasal formulation of metoclopramide is the only non-oral and non-injectable product in development and, if approved, may have the distinct advantage of being on the market for several years as the only new treatment approved to address this debilitating disease in these patients with erratic gastric emptying.

Shares of Evoke were up 12.5 % at $3.77 on Tuesday. The stock has a consensus analyst price target of $16.15 and a 52-week trading range of $2.80 to $8.32.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.