Otonomy shares positive top-line results from hearing loss trial

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 d…

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Investigational tinnitus drug shows promise in Phase 1/2 study

Neurotology drug developer Otonomy (NSDQ:OTIC) has announced that its OTO-313 drug appeared to reduce tinnitus severity in some participants in a small study.

In the study, summarized in Otology & Neurotology, patients with moderate to severe unilateral tinnitus received intratympanic administration of the drug or placebo.

Six OTO-313 recipients out of 14 (43%) showed a meaningful improvement in Tinnitus Functional Index score at weeks four and eight of the study. Conversely, 13% of placebo recipients showed the same level of improvement.

Patients who responded to the drug reported reductions in tinnitus loudness and distress.

The study also found that OTO-313 was well-tolerated, with adverse events greater in placebo recipients.

OTO-313 is a formulation of the selective N-methyl-D-aspartate (NMDA) receptor antagonist gacyclidine.

“Publication of these positive clinical results is an important milestone for the millions of people…

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Otonomy expands Phase 1/2 hearing loss clinical trial

Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients who have difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection.

The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort.

The randomized, double-blind, placebo-controlled Phase 1/2 study will be relatively small, involving approximately 30 hearing loss patients. A total of 20 people will receive OTO-413 with the remainder receiving placebo.

“We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial,” said David A. Weber, president and CEO of Otonomy, in a statement.

OTO-413 is a formu…

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