Subject 1 (270 Days
post-BB-301 dose):
Global inefficiency of swallowing for solid food,
thin liquid, and thick liquids drives dysphagia for Subject 1.
Subject 1 displayed continued clinically meaningful reductions (i.e., improvements) in SSQ
Total Score (35% reduction) and SSQ Sub-Scores (42% reduction for Thin Liquid, 16% reduction for Solid Food, and 22% reduction for Thick Liquids). Subject 1 displayed correspondingly significant reductions
(i.e., improvements) in VFSS TPR (33% reduction for Thin Liquid, 18% reduction for Solid Food, and 30% reduction for Thick Liquids) following the administration of the low-dose of BB-301 as compared to the average values recorded for Subject 1 during the pre-dose period.
Subject 2 (180 Days
post-BB-301-dose):
Pathologic low-volume sequential swallowing for thin liquid drives dysphagia for Subject 2. Pathologic low-volume sequential swallows are experienced by the subject as multiple swallows
and are detected during VFSS as a series of rapid contractions of the pharyngeal muscles interrupting the discrete peristaltic contraction pattern typically observed during swallows of low volumes of thin liquids.
Subject 2 displayed clinically meaningful reductions (i.e., improvements) in SSQ Total Score (89% reduction) and the SSQ
Sub-Score for the necessity of repeat swallows during consumption (84% reduction) as compared to the average values recorded for Subject 2 during the pre-dose period.
The average post-dose SSQ Total Score of 82 is representative of a clinically normal swallowing profile for Subject 2. Subject 2 displayed correspondingly significant reductions (i.e., improvements) in the post-dose frequency of low-volume sequential swallows as evaluated by VFSS (92% reduction) following the administration of the low-dose of BB-301 as compared
to the pre-dose values recorded for Subject 2 during the pre-dose period.
All study Subjects are blinded to their SSQ Total Scores and VFSS TPR assessment results, and the Central Reader for the VFSS assessments is blinded to the
SSQ Total Scores and SSQ Sub-Scores for all Study Subjects.
Company Webcast Information:
A live webcast of the interim clinical data presentation, including management and Emily Plowman, PhD, CCC-SLP,
FASHA Professor, Department of Otolaryngology Head and Neck Surgery, The Ohio State University College of Medicine, will be held at 8:30AM EDT on Monday October 14th, 2024, and
can be accessed here. Investors may also dial in toll-free at 1-877-269-7751 or 1-201-389-0908 (international). The conference ID is 13749637. The event replay will be placed on the News & Events tab on the Investor page of the Benitec
website.