Zogenix’s Phase 3 Clinical Study Met all Endpoints
Zogenix announced on Thursday (July 12) that its Phase 3 trial of ZX008 in Dravet syndrome met its primary and secondary endpoints, putting both regulatory submissions for the drug’s approval on pace for Q4 2018.
With every clinical study there’s a risk the drug candidate won’t amount up to the expectations of its indication, or worse– cause dangerous adverse effects. This is even more risky for a Phase 3 study, which incurs the most time and funding.
Luckily, on Thursday (July 12) Zogenix (NASDAQ:ZGNX) was able to release its Phase 3 trial of ZX008 in Dravet syndrome met its primary and secondary endpoints, proving the drug was superior to the placebo when added to a stiripentol regimen. ZX008 was tested as a treatment for children and young adults with the disease.
“If approved, ZX008 has the potential to be a transformative treatment for Dravet syndrome, a rare and serious form of epilepsy with few available treatment options,” professor Rima Nabbout, principal investigatory of the study said in the press release.
In the trial, patients taking ZX008 had a 54.7 percent greater reduction in mean monthly convulsive seizures compared to placebo. The median convulsive seizure frequency was 62.7 percent in the ZX008 group compared with just 1.2 percent in the placebo group of patients.
As the study had an over 50 percent reduction in seizure frequency and longest seizure-free interval, it proves the study’s trial demonstrated statistically significant improvement trial.
Similar to the Phase 1 trial of the same drug candidate, the adverse events were consistent. The events were also similar for placebo patient group as with the ZX008 group.
ZX008 has already received orphan drug designation in both the U.S. and Europe, as well as breakthrough therapy designation in the U.S. to treat Dravet syndrome. Both regulatory submissions for the drug’s approval are on pace for Q4 2018.
Zogenix is developing drug for severe central nervous system (CNS) disorders, with limited or no treatment options. In addition to this trial for Dravet syndrome, the company is also working on Lennox-Gastaut syndromes.
As for the second indication, the company initiated a Phase 3 trial in November, 2017.
As with most positive clinical result announcements, Zogenix saw an impressive share price increase following Thursday’s announcement.Over the one-day trading period, the company’s share price increase was 20.73 percent to close the trading session at US$55.90.
TipRanks shows one analyst, Difei Yang with Mizuho Securities, released a note to investors on Thursday with a US$69.00 price target and reiterating a “buy” position.
Although company news from Zogenix has been quiet over the last eight months, this announcement is one to remember. If all goes well with the company, investors can expect to hear it submitted its new drug application in Q4.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.