Phase III study of PH 94B shows safety and functional improvements in social anxiety disorder

For the primary endpoint of safety and tolerability (safety population: n=481), the long-term administration of 3.2 microg of fasedienol, up to four times a day, as-needed, was safe and well-tolerated, with no new safety findings or trends identified, regardless of the number of doses administered by each subject. Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives. Analysis of the final data set demonstrates clinically meaningful functional improvement, as measured by the LSAS, and total LSAS scores continued to decline in consecutive months during the study.

The long-term intranasal administration of 3.2 microg of fasedienol, up to four times a day, as-needed, was safe and well-tolerated in adult SAD patients (n=481). Of the 481 SAD patients in the study who received at least one dose of fasedienol, at least one treatment-emergent adverse event (TEAE) was reported by 56.8% of subjects, with 54.9% of the 481 patients reporting mild or moderate TEAEs and only 1.9% of patients reporting severe TEAEs. Headache was the most common TEAE (17.0%); no other TEAE occurred in more than 5.0% of subjects, except for COVID-19 TEAEs (11.4%), which were not considered related to fasedienol. Fourteen patients (2.9%) experienced a TEAE leading to discontinuation from the study. Six patients (1.2%) experienced a treatment-emergent serious adverse event, none of which were considered related to fasedienol.

The safety and exploratory LSAS results of this Phase III open label study build on the safety and LSAS efficacy results from a previous randomized, double-blind, placebo-controlled Phase II study of fasedienol in a real-world setting. Results from that study suggested that self-administration of fasedienol on an as-needed basis prior to anxiety-provoking situations was accompanied by a persistent change in overall SAD symptoms, reduction in fear and anxiety, and less frequent avoidance, as measured by the LSAS over the course of fasedienol usage. Notably, in the placebo-controlled Phase II study, the amount of separation between fasedienol and placebo at the end of the first 2 weeks on the LSAS was comparable to what was observed after 12 weeks in the registration trials for the three medications currently approved by the FDA for the treatment of SAD, two SSRIs and one SNRI. All prior registration studies for these medications were positive, and all studies used the LSAS as the primary efficacy endpoint.