Zosano Pharma Corp. (NASDAQ: ZSAN) saw its shares absolutely skyrocket on Monday after the firm gave an update on its late-stage trial for the treatment of migraines. Basically, the lead product candidate, M207, met both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours.
Overall the trial was a success with higher pain freedom rates achieved on all doses after 60 minutes over placebo. Specifically, in terms of the timing, Zosana reported:
- 41.5% of patients experienced freedom from pain at 2 hours vs. 14.3% for placebo.
- 68.3% of patients experienced freedom from most bothersome symptom at 2 hours vs. 42.9% for placebo.
- 26.8% of patients experienced freedom from pain at 1 hour vs. 10.4% for placebo.
Also one of the key highlights from the report was that the 3.8 mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and one hour and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any serious adverse events.
Zosana will continue the development of M207, working toward filing an FDA New Drug Application (NDA). No time frame was reported in the release.
Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Clinic, commented:
The ZOTRIP study was successful from the dual perspectives of meeting the co-primary endpoints and no serious adverse events. The study demonstrated a statistically significant 2-hour pain freedom response rate with a low placebo rate for the primary endpoint. The data also indicate a durability of effect at 24 and 48 hours, and meaningful pain freedom rate at 1 hour. If approved by the FDA, M207 has the potential to become an important treatment option for those suffering from migraine.
Excluding Monday’s move, Zosano has outperformed the broad markets with the stock up 54% year to date. However, over the past 52 weeks the stock is actually down 42%.
Shares of Zosano were last seen up 72% at $2.12, with a consensus analyst price target of $2.00 and a 52-week trading range of $0.45 to $2.83.