The neurotology biopharma Otonomy (Nasdaq:OTIC) has announced that the brain-derived neurotrophic factor agonist OTO-413 resulted in clinically meaningful improvement in a Phase 2a trial focused on subjects with hearing loss.
In the randomized, double-blind, placebo-controlled study, subjects received a single intratympanic injection of 0.3 mg of OTO-413.
Subjects in the study had 30 evaluable subjects with up to moderately-severe hearing loss.
A sustained exposure formulation of brain-derived neurotrophic factor (BDNF) bested placebo in multiple speech-in-noise (SIN) hearing tests.
The trial also administered the Patient Global Impression of Change (PGIC) on days 57 and 85 of the study.
A total of 40% (8 of 20) of OTO-413 recipients had a clinically-meaningful improvement in at least one of the three SIN tests. Conversely, two out of 10 placebo recipients achieved a comparable level of positive change.
Three of the patients in the drug group had clinically-meaningful improvement on at least two SIN tests.
OTO-413 also fared similarly in a Phase 1/2 study.
Otonomy plans on launching a full dose-ranging Phase 2 study in hearing loss patients by the end of the year.
The company’s stock increased 5.53% to $2.29. It has fallen significantly in recent years from an all-time high of $39.36 on March 13, 2015.