Otonomy Archives - Medical Design Sourcing

Otonomy plans to dissolve

The neurotology biopharma Otonomy (Nasdaq:OTIC) is planning to liquidate and dissolve its business. It plans to distributing any remaining cash to shareholders after its operations have been suspended and its pipeline assets have been sold.

The company also announced that it had terminated all of its employees effective December 15.

In 2017, Otonomy announced that a Phase 3 clinical study of its pipeline drug Otividex missed its primary endpoint in treating Ménière’s disease. Otividex was an extended-release form of dexamethasone.

In August 2022, it announced disappointing data from a Phase 2 study focused on testing OTO-313 in tinnitus.

At that point, the company laid off 55% of its staff and shifted its focus to OTO-413, a brain-derived neurotrophic factor agonist OTO-413 that yielded a clinically meaningful improvement in a Phase 2a hearing loss study.

Otonomy said it expected to pay roughly $5 million in severance and other…

Otonomy gives up on experimental tinnitus drug after disappointing Phase 2 trial

Neurotology-focused biopharma Otonomy (Nasdaq:OTIC) will cease development of OTO-313 after the experimental drug failed to show clinically meaningful benefit in a randomized, placebo-controlled Phase 2 trial.

The company’s lead asset, OTO-313, did not meet either primary or secondary endpoints in the study, which involved 152 patients with persistent, unilateral tinnitus of at least moderate severity.

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

The San Diego–based company’s share price dropped almost 80% in mid-day trading to $0.31. On March 13, 2015, its stock price hit an all-time high of $39.36.

[Related: Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients]

The primary endpoint was related to an at least 13-point improvement on the Tinnitus Functional Index (TFI) one month and two months following treatment. For context, t…

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…

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…

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…