Zosano Pharmaceuticals $ZSAN went through a very bad year after raising $50 million in an IPO floated at the beginning of 2015. Its two big partners – Eli Lilly and Novo Nordisk – both pulled out of their collaborations and Zosano’s initial $11 share price was shredded.
This morning, though, Zosano got a small piece of that lost market cap back after the biotech reported that its microneedle patch system for delivering an old migraine drug came through in a pivotal Phase III study, setting up a campaign to file an NDA.
According to investigators, the high dose in the study – 3.8 mg – achieved a statistically significant response in short order. M207 beat out a placebo for achieving freedom of pain at 45 minutes and an hour as well as 24 hours and 48 hours.
The biotech’s shares rocketed up 100%, but Zosano’s market cap had shriveled after its earlier setbacks. The company is also advancing a new/old migraine approach at a time several big players are angling for the lead in developing a new migraine therapy with new mechanisms of action.
Eli Lilly, Amgen/Novartis, Allergan, Alder and Teva have been hard at it gathering data on new CGRP therapies. Lilly also recently acquired CoLucid and its late-stage migraine drug lasmiditan, an oral 5-HT agonist.
Little Zosano, though, believes it can factor in on a market with millions of patients. The biotech recruited 589 subjects for their study, testing a new delivery approach for the triptan zolmitriptan.
“ZOTRIP was designed to be a dose-ranging study, as well as a registration study. We are very pleased by the results for the 3.8mg dose, and look forward to continuing the development of M207 towards filing an NDA and working to bring this novel therapy to patients suffering from the incapacitating effects of migraines,” said Zosano CEO Konstantinos Alataris.
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