EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other EventsItem 8.01Other Event.
On October 23, 2017, Evoke Pharma, Inc. (the “Company”) announced positive topline results from the Company’s comparative exposure pharmacokinetic (“PK”) study. The trial was designed to demonstrate that a proposed dose of Gimoti, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has similar systemic exposure to that of the referenced listed drug (“RLD”), Reglan Tablets. Based on these results, the Company will submit a 505(b)(2) New Drug Application (“NDA”) with a selected Gimoti dose to the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2018.
The PK study was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence. Following discussions at pre-NDA meetings with FDA, Evoke planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (“AUC”) falling within the bioequivalence range of 80-125% of the RLD. Two of the three doses tested met the selection criteria. The maximum observed plasma concentration (Cmax) for Gimoti was slightly lower than the bioequivalence range, which had been previously discussed with FDA as a likely outcome given the different route of administration and prior Gimoti PK study results. Additionally, data showed the AUC and Cmax increased in a dose related manner across all three strengths tested. Relative to safety, all Gimoti doses were well‑tolerated with no clinically significant adverse events reported following any of the doses.
Safe Harbor Statement
Evoke cautions you that statements included in this report 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: Evoke’s beliefs about the study data, including that the objective of the PK study has been met on the measure of AUC and that the topline results demonstrate comparable bioequivalence between the oral Reglan Tablets and Gimoti’s nasal delivery; beliefs that the AUC measurement is the most clinically relevant PK parameter for this study; the timing of the submission of the NDA to the FDA; Evoke’s expectation that the PK trial will be the final clinical trial for Gimoti prior to NDA submission; Evoke’s believe that Gimoti may become the new standard of care for patients suffering from gastroparesis; and Evoke’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 Evoke's business, including, without limitation: the topline data Evoke has reported from the PK study is based on preliminary analysis of key data, and such data may change following a more comprehensive review of the data related to the PK study and such topline data may not accurately reflect the complete results of the study, and the FDA may not agree with Evoke’s interpretation of such results, including risks associated with Cmax falling below the bioequivalence range; 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; risks that the FDA may require additional efficacy or safety studies prior to submission or approval of the NDA; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; Evoke’s dependence on third parties for the manufacture of Gimoti as well as the submission of the NDA; Evoke may require additional funding to submit the NDA and conduct any additionally required studies, 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 Evoke's prior 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 Evoke 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.