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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The top pharma stories of early 2021

Image courtesy of Nataliya Vaitkevich via Pexels.

COVID-19 vaccines dominated pharma industry news during the first half of this year.

It’s little wonder, too, since vaccines are the best hope to return the world to some kind of post-pandemic “normal.”

As with any new medical treatments — especially ones authorized amid an emergency — there have been questions about side effects. Drug Discovery & Development delved into what experts and scientific studies are saying. The overall conclusion is clear: While reactogenicity is a valid concern, the benefits of COVID-19 vaccines greatly outweigh the risks for the vast majority of patients.

Here are eight stories of our stories that delved into potential COVID-19 vaccine side effects:

Dizziness among common COVID-19 vaccine side effects Tinnitus reports grow amid COVID-19 vaccinations Moderna COVID-19 vaccine might cause facial swelling for p…
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