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Also known as AAVAnc80-antiVEGF via Akouos Delivery Device
AK-antiVEGF · 1 trial · 1 indication
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device. |
| Cohort 2 | EXPERIMENTAL | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device. |
| Cohort 3 | EXPERIMENTAL | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device |
| Name | Type | Description |
|---|---|---|
| AAVAnc80-antiVEGF via Akouos Delivery Device | COMBINATION_PRODUCT | AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device |
Criteria for Inclusion: 1. Presence of unilateral, progressive vestibular schwannoma. 2. Vestibular schwannoma larger than 2 mm. 3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear. 4. Able and willing to comply with all trial requirem...
AK-antiVEGF is an investigational gene therapy being studied for vestibular schwannoma, a noncancerous tumor that grows on the nerve connecting the ear to the brain. It is delivered using the Akouos Delivery Device and is also known as AAVAnc80-antiVEGF via Akouos Delivery Device. It is in Phase 1 clinical development.
AK-antiVEGF is being studied for the treatment of vestibular schwannoma, a tumor affecting the vestibular nerve. The Phase 1 trial enrolls adults 18 years and older with this condition. Vestibular schwannoma falls within the oncology therapeutic area for this program.
AK-antiVEGF is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The program uses the Akouos Delivery Device for administration. Lilly is the sponsor of the ongoing clinical study of this gene therapy candidate.
AK-antiVEGF is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. One Phase 1 trial is currently active and recruiting participants, with no completed trials reported for this program.
AK-antiVEGF is being evaluated in one clinical trial, NCT06517888, titled Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma. The Phase 1 study is recruiting in the United States and plans to enroll 27 participants. It is a controlled trial open to adults 18 years and older of all sexes.
Yes, AK-antiVEGF is also known as AAVAnc80-antiVEGF via Akouos Delivery Device. Both names refer to the same investigational gene therapy developed by Eli Lilly and Company for vestibular schwannoma. The alternative name reflects the AAVAnc80 vector and the Akouos Delivery Device used to administer it.