US biopharma company Satsuma Pharmaceuticals has dosed the first patient in its phase 3 EMERGE clinical trial of STS101 (dihydroergotamine (DHE) nasal powder) for migraine treatment.

The EMERGE efficacy trial is a single-dose, double-blind, randomized, placebo-controlled, parallel-group study to be held in multiple centers. The phase 3 clinical trial will feature nearly 1,140 migraine patients and is being held in the US.

The EMERGE trial for migraine treatment was designed in compliance with FDA recommendations as defined in the FDA Guidance Migraine:  Developing Drugs for Acute Treatment, February 2018.

After having their full eligibility established, participants in the EMERGE clinical trial are randomly grouped 1:1:1 to be subjected to one of three treatments – STS101 DHE 3.9 mg, STS101 DHE 5.2 mg or matching placebo and will have their next migraine attack of at least moderate pain severity treated with the respective blinded study medication.

Satsuma begins EMERGE clinical trial of STS101 in migraine. Image courtesy of marin at FreeDigitalPhotos.net.

Primary endpoints of EMERGE clinical trial of STS101 in migraine

According to Satsuma Pharmaceuticals, the two co-primary endpoints of the EMERGE migraine clinical trial to be judged at two hours after administration of STS101 are freedom from pain and freedom from most bothersome symptom, which will be from among photophobia, nausea, or phonophobia).

The EMERGE clinical trial is statistically designed for more than 99% power for the freedom from pain endpoint and more than 95% power for the freedom from most bothersome symptom endpoint.

Apart from that, the design of the EMERGE trial for migraine treatment has various secondary endpoints and prospective assessments of the clinical performance of STS101 in multiple patient subgroups to differentiate the clinical profile of the investigational migraine drug.

John Kollins – Satsuma Pharmaceutical President and CEO said: “We are pleased to have recently dosed the first patient in our Phase 3 EMERGE efficacy trial, which we believe is the largest-ever clinical trial undertaken with any DHE product.  This milestone brings us a step closer to achieving our goal of making STS101, a compact, simple-to-use, self-administered, and non-injectable DHE dosage form, available as a differentiated treatment option for people with migraine.”

Satsuma Pharmaceuticals is hoping to announce top-line data from the EMERGE clinical trial in H2 2020.

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