It took Evoke Pharma two years and a couple rounds of fundraising to slice and pull the data for an NDA of its only drug out of a Phase III wreckage. But just a month before the FDA was slated to give its verdict, the biotech reported that the effort might not have been enough after all.
The agency has seen deficiencies during the initial stage of its review, Evoke said on Monday, in three critical sections of the NDA. Although the comments outlined in the multi-disciplinary review are preliminary, the company conceded that “approval of Gimoti by the PDUFA date of April 1, 2019 is uncertain given the letter.”
Investors of the microcap biotech $EVOK were alarmed, triggering a 57% landslide in share price throughout the day, ending at $1.35.
An intranasal spray formulation of the FDA-approved metoclopramide, Gimoti (EVK-001) was designed to overcome the limitations of oral drug delivery in diabetic gastroparesis, given that patients often experience symptoms — such as vomiting and gastric emptying — that hinder absorption of the oral medication. The drug also specifically targets women, who make up the majority of the patient population.
After the drug failed a Phase III study in 2016, hammering the stock, Evoke — too low on cash to conduct another late-stage trial — instead ran a series of post-hoc analysas and concluded that Gimoti was effective among those with moderate to severe symptoms like nausea and upper abdominal pain. The San Diego-based company also rolled out new pharmacokinetic data to show there are “statistically significant differences in exposure between men and women given the same metoclopramide dose.”
That was enough to earn them a place in the queue. But in its entirety, the FDA found the NDA’s descriptions on chemistry, clinical and pharmacology all wanting:
- Chemistry: combination product quality control and reproducibility specific to the commercially available sprayer device used with Gimoti;
- Clinical: lack of adequate information to support sex-based efficacy differences;
- Clinical Pharmacology: maximum concentration (Cmax) not within the parameters for bioequivalence for abbreviated NDAs
The Evoke team is working to evaluate and address the FDA’s concerns, with a plan to respond before the PDUFA of April 1, CEO Dave Gonyer said.
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