The official record for the study, “A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss”, was added to ClinicalTrials.gov on September 30, 2021.
The name of this new study is “VESTA”, the name of the drug is “AUD1001” (also known as “LY3056480”), and it is sometimes referred to as the “REGAIN treatment” for hearing loss.
Official description from the new study record (9/30/2021):
VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology – Head & Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).
Source —link to the study record:
LY3056480 in Patients with Sensorineural Hearing Loss (NCT05061758)
More background and context — from Audion’s website:
AUD1001 was shown to be safe and well tolerated, and provided early indications of efficacy in speech in noise, a key clinical outcome parameter. Importantly, the efficacy signals persisted a year after the treatment.[…]
Audion is preparing for initiation of new clinical trials of AUD1001 for sensorineural hearing loss at multiple sites in Europe and in the US in H2 2021. The planned Phase 2b double blind, placebo controlled trials will be conducted in adults with demonstrated loss of clarity, using a standardized local drug delivery.
More details about the AUD1001 study:
- phase 2 study will enroll 135 participants
- recruitment has NOT started yet
- three recruitment locations listed so far: Illinois, New York, Virginia
- company website mentions sites in Europe but the study record says participants will be recruited through sites in the US
- that does not rule out Europe sites (since the study record could be updated when new sites are added in the future)
- so, right now there is a slightly confusing inconsistency — but nothing is contradictory or set in stone
As for timeline…
- Start Date: September 2022
- Primary Completion Date : September 2024
- Study Completion Date : March 2025
Keep in mind, these are Estimated dates, and subject to change.
The key date here, for most people, is the September 2022 start date.
As for when RECRUITING will begin…
Not sure yet.
But I will send out an email when the status changes from “Not yet recruiting” to “Recruiting” — as soon as I find out. Nothing to report just yet and no estimates or opinions to share.
If you are not subscribed and want AUD1001 updates, I have a strongly-biased (and very good) recommendation: subscribe to the Hearing Loss Treatment Report email newsletter. Email updates for people who want “early access” to hearing loss treatment updates — like this one about AUD1001… in many cases, before the company has had time to issue a press release! (That is what happened here.) Expect between 1-3 emails per week, on average. Sometimes none. Sometimes four. It depends. But the important thing is, issues are only sent when something exciting and new is happening. No recycled stories or press releases. No blogspam. No advertorials or sneakiness. No spam, no nonsense. Unsubscribe instantly with one click.
More AUD1001 updates to follow… including an update whenever the trial opens its doors and begins recruiting. Which, hypothetically, could be any day now.