A rival is already looming for GW Pharmaceuticals $GWPH, the drugmaker who scored the very first cannabis-derived drug approval only weeks ago to treat rare forms of epilepsy. Now, Zogenix is on their heels with positive Phase III data for its drug targeting the same indication.
Investors are rejoicing, with Zogenix’s $ZGNX stock climbing nearly 25% in pre-market trading. The stock price has already soared 210% in the past 12 months.
The Emeryville-based company reported its experimental med ZX008 triggered a dramatic drop in the rate of seizures experienced by patients with Dravet syndrome, a rare form of childhood epilepsy. The Phase III study (the second of two) saw 43 patients had a median reduction of 62.7% in convulsive seizures per month. That’s compared to 1.2% on placebo. The other Phase III study Zogenix reported back in September saw a median reduction of 72.4%, while placebo only saw a drop of 17.4%.
ZX008 is a low-dose formation of fenfluramine, one part of the infamous weightloss drug combo “Fen-Phen” — banned back in the 1990s due to cardiac risk. In Zogenix’s two Phase III studies, its version of this drug did not trigger cardiac side effects.
“Based on these highly compelling top-line results from both of our pivotal studies, we are now focused on submitting applications for regulatory approvals in the US and Europe in the fourth quarter of 2018,” said Stephen Farr, president and CEO of Zogenix, in a statement. “We are excited about ZX008’s potential to have a major impact in the treatment of patients with Dravet syndrome and their families.”
The Phase III news comes less than a month after GW Pharmaceuticals scored a green light on Epidiolex, grabbing its first ever marketing OK for one of its cannabinoid drugs and setting up the biotech for a major shift toward commercialization. The drug was approved to treat seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
Clarivate has pegged 2022 Epidiolex sales at a blockbuster-sized $1.2 billion. But rivals like Zogenix’s ZX008 could certainly cut into that, if it reaches the market.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 32,300+ biopharma pros who read Endpoints News by email every day.Free Subscription