EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other EventsItem 8.01Other Event.
On August 14, 2017, Evoke Pharma, Inc. (“Evoke” or “the Company”) issued a press release announcing the initiation of its comparative exposure pharmacokinetic (PK) trial for Gimoti™, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.
The study is designed to demonstrate that the proposed dose of Gimoti has similar systemic exposure to that of the listed drug, Reglan® Tablets, and PK data will be part of the basis for the Company’s planned 505(b)(2) new drug application (NDA) to the U.S. Food and Drug Administration (FDA). The study is a single dose, crossover design in which approximately 100 healthy volunteers will receive Reglan Tablets and three different doses of Gimoti. The study will be conducted by Spaulding Clinical Research, a clinical research organization (CRO) that successfully completed the Company’s thorough ECG trial for Gimoti in 2014. The Company expects to complete the analysis of the trial data and announce results in the fourth quarter of 2017, followed by a potential NDA submission in late 2017 or early 2018.
Forward Looking Statement
The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding: the Company’s plans to include the PK data in the 505(b)(2) NDA for Gimoti; the timing of announcement of the results of the PK trial and the timing of the submission of the NDA to the FDA; the Company’s expectation that Spaulding Clinical Research will complete the study; the Company’s expectation that the PK trial will be the final clinical trial for Gimoti; and the Company’s belief that there is a large unmet need for an effective treatment for diabetic gastroparesis. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: risks associated with successfully initiating, conducting and receiving favorable results from the PK trial; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings, including inconsistent conclusions reflected in the official meeting minutes from the FDA; the inherent risks of clinical development of Gimoti; the Company is entirely dependent on the success of Gimoti, and the Company cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; risks associated with manufacturing new formulations of Gimoti for use in the PK trial; the Company’s dependence on third parties for the manufacture of Gimoti as well as the submission of the NDA; the Company’s dependence on Spaulding Clinical Research to conduct the PK trial; the Company may require additional funding to complete the PK trial and submit the NDA, and will require substantial additional funding to commercialize Gimoti, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks detailed in the Company's periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females. EVOKE PHARMA, INC. (NASDAQ:EVOK) Recent Trading Information
EVOKE PHARMA, INC. (NASDAQ:EVOK) closed its last trading session down -0.05 at 2.24 with 62,045 shares trading hands.