Zosano has announced positive results from their Phase 3 clinical trial of M207, the companies lead candidate for the treatment of migraine attacks. M207 is a zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan, a selective 5-HT1B/1D receptor agonist.
The ‘ZOTRIP’ study was a double-blinded trial, comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo in patients who had a history of at least 1 year of migraine episodes with or without aura, and who had 2–8 migraine attacks per month, documented during a trial run-in period.
In total, 333 subjects were treated and included in the safety analysis. Participants were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack, termed “qualifying migraine,” in which the most bothersome symptom had to be present. Pain severity was scored by participants on a 4-point scale, starting pre-dose and then at several intervals over 48 hours post-dose.
Results showed the co-primary endpoints of pain freedom and most bothersome symptom free, were statistically significant for the 3.8mg dose vs. placebo. At two hours after migraine onset, 41.5% reported pain freedom and 68.3% reported being free from most bothersome symptom in the 3.8mg dose, compared to 14.3% and 42.9% in the placebo group. Durability of these affects were demonstrated at 24 and 48 hours.
The 1.0mg and 1.9mg doses of M207 produced p-values less than 0.05 in pain freedom at 2 hours, however they did not produce a p-value below 0.05 for freedom from most bothersome symptom at 2 hours.
“The data also indicate a durability of effect at 24 and 48 hours, and meaningful pain freedom rate at 1 hour,” said Stewart Tepper, MD, Director of the Dartmouth Headache Clinic. “If approved by the FDA, M207 has the potential to become an important treatment option for those suffering from migraine.”
The most frequently reported adverse event was redness at the application site (18.3% of participants), with all cases of redness resolved.
For more information visit Zosanopharma.com.