Aeterna Zentaris Climbs On Phase 3 Announcement

On Friday, Aeterna Zentaris (AEZS) announced that it would be reporting results for its phase 3 ZoptEC Phase 3 clinical study. On this news the stock closed the day higher by 9.84% to $3.35 per share. Why is this announcement significant? It is because the phase 3 trial is testing women with locally advanced, recurrent, or metastatic endometrial cancer. The phase 3 trial is testing the company’s drug known as Zoptrex.

This will be a huge binary event for Aeterna Zentaris, which in the past had its fare share of failures. This includes the phase 3 colo-rectal cancer drug failure that Aeterna partnered with Keryx pharmaceuticals (KERX) on many years ago. Another issue involves the 2014 CRL for Macrilen, a growth hormone deficiency drug. The mix up with the NDA was really bad. The reason why the FDA rejected the company’s drug was because Aeterna did not specify the primary endpoint that was agreed to in the Special Protocol Assessment — SPA. This SPA was supposedly agreed to by the FDA and Aeterna Zentaris.

The news sent the stock flying, because there is a good chance that Aeterna Zentaris will post positive phase 3 results. This is evidenced by the fact that the phase 2 trial did see some pretty good results. The phase 2 study recruited a total of 43 patients with advanced or recurrent endometrial cancer. Patients were given 267 mg/m2 by intravenous infusion over a 2 hour period. The patients continued the treatment every 3 weeks for a total of 6 courses. The main positive from the study was the secondary endpoint which was overall-survival. The overall survival in the study was over 15 months.

If Aeterna Zentaris posts positive results on Monday, the stock will soar much higher. Of course as with anything in biotech, there is some risk involved. The results could possibly end up being mixed or even worse, fail altogether. Phase 3 trials are no easy feat as observed in the colo-rectal phase 3 cancer trial by Aeterna and Kerxy many years ago. Hopefully, the results will be positive to help these women receive treatment that is not only effective but much safer to use than other types of treatments.