Little Zosano takes another beating as the FDA slaps down their application for a migraine patch
Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.
The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.
Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.
Wednesday’s rejection may have already been in the cards for Zosano, as the company noted last month that the FDA issued a disciplinary letter citing high plasma concentration levels of zolmitriptan in five patients. At the time, Zosano noted in a press release that approval for the drug was “not expected.”
Those concerns were again listed in the CRL, ultimately muddying the waters to interpret the drug’s safety data. To rectify the situation, the FDA recommended that Zosano conduct a repeat bioequivalence study between three of the lots used during development.
Regulators added in their letter that they were unable to examine Qtrypta’s manufacturing line due to restrictions on government travel, Zosano said, but will conduct such evaluations should the company re-submit its application.
Zosano’s application for Qtrypta was based on a Phase II/III trial completed in 2017. That study met both its co-primary endpoints, with 41.5% of patients treated with the 3.8 mg dose of Qtrypta achieving pain freedom at 2 hours and 68.3% reporting freedom from their most bothersome symptom also at 2 hours.
In a long-term safety study, Zosano said 95% of side effects were mild, and more than 80% resolved within 48 hours. Less than 2% of patients reported triptan-like neurological side effects typically found in the class, such as dizziness and paresthesia.
Qtrypta itself is a reformulation of zolmitriptan, delivered through titanium needles coated with the drug.
Zosano has had a rocky history after raising $50 million for an IPO at the beginning of 2015. Soon after debuting, the company’s $11 share price was shredded when its two big partners — Eli Lilly and Novo Nordisk — both pulled out of their collaborations. Though the pivotal Phase III for Qtrypta doubled Zosano’s stock after the readout, the company has been in the penny stock range for most of 2020.