Positive results from phase 1 study of nasal spray for MDD allows US phase 2b trial development

Key takeaways:

• Intranasal itruvone was well-tolerated with serious adverse events recorded in two studies.
• Positive results from these trials will enable phase 2b development to begin in the U.S.

A biopharmaceutical company has announced positive safety and tolerability data from a United States-based phase 1 clinical trial of its investigational rapid-onset pherine nasal spray to treat major depressive disorder.

According to a release from Vistagen, data from the U.S. clinical trial built on successful phase 1 studies as well as positive results from a randomized, double-blind, placebo-controlled phase 2a study of itruvone previously conducted in Mexico. The combined success from these clinical trials is expected to enable phase 2b development of the pherine therapeutic in the U.S., per the release.

The U.S. phase 1 study was a randomized, double-blind, placebo-controlled trial investigating safety and tolerability of both single and multiple doses of intranasal itruvone in healthy adults. No serious adverse events or discontinuations due to adverse events in the study were reported, with only two incidents of mild fatigue and headache occurring in the same participant. Itruvone was also well-tolerated and demonstrated a favorable safety profile consistent with previous studies.

The study in Mexico was a randomized, double-blind, placebo-controlled parallel design phase 2a trial, in which intranasal itruvone was given daily at 3.2g and 6.4g for 8 weeks.

After 1 week of treatment, mean reduction on the 17-item Hamilton Depression Scale (HAM-D-17) scores for the itruvone 6.4g group was significantly greater than in the placebo group from baseline. Additionally, by week 8, the itruvone 6.4g group maintained a significant reduction in mean HAM-D-17 score from baseline compared with the placebo group. Itruvone was well-tolerated and no serious adverse events or psychological side effects were recorded.

“The need for faster-acting, safer and more effective medications is unrelenting, especially in an environment where the gap between innovative treatment options and the prevalence of depressive disorders is increasing,” Shawn Singh, CEO of Vistagen, said in the release. “With a successful phase 1 study in the U.S. and a positive phase 2a study conducted outside the U.S. in hand, we look forward to advancing itruvone into phase 2b development in the U.S., on our own or with a partner.”