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Milestone Pharma Shares Crater As Study Results Miss Primary Endpoint

Courtesy of Benzinga

Milestone Pharma Shares Crater As Study Results Miss Primary Endpoint

Shares of small-cap Milestone Pharmaceuticals Inc (NASDAQ: MIST) were losing three-quarters of their value Tuesday on the back of a negative clinical readout.

Milestone, which went public in mid-2019, said a Phase 3 study dubbed NODE-301 that evaluated its investigational etripamil nasal spray therapy for the treatment of paroxysmal supraventricular tachycardia, or PSVT, did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the 5-hour period following drug administration.

PSVT is a broad term that includes many forms of heart rhythm problems originating above the ventricles in the atria or AV node.

The steep stock plunge doesn’t come as a surprise, as etripamil is the company’s lead drug candidate under evaluation in multiple indications. The investigational compound is in the most advanced stage of development for PSVT.

Top-line results from the study that evaluated a 70mg dose in 431 patients enrolled across 65 sites in the U.S. and Canada showed that the median time to conversion of the treatment arm was 25 minutes compared to 45 minutes for the control arm, which was not statistically significant.

Etripamil showed early activity, but results from the latter part of the analysis confounded the statistical analysis of the primary endpoint, according to the company. 

Milestone said the study did show statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient reported treatment satisfaction. Additionally, there was a trend in improvement in the percentage of patients seeking rescue medical intervention.

The safety and tolerability data from the NODE-301 study are supportive of at-home use of etripamil, with adverse events consistent with those observed in prior trials, according to Milestone. 

“We will continue to execute as prudently possible on the ongoing NODE studies, including NODE-301B, and look forward to reviewing these data with regulators,” CEO Joseph Oliveto said in a statement. 

The stock was plunging 82.39% to $2.46 in premarket trading Tuesday.

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The Week Ahead In Biotech: Bristol-Myers, Rockwell Medical Await FDA Decisions, COVID-19 Updates In Focus


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