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AAVAnc80-antiVEGF via Akouos Delivery Device · 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...
AAVAnc80-antiVEGF via Akouos Delivery Device is an investigational gene therapy being developed for the treatment of vestibular schwannoma, a type of non-cancerous brain tumor. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
AAVAnc80-antiVEGF via Akouos Delivery Device is a gene therapy designed to deliver an anti-VEGF agent to target vestibular schwannoma. The therapy uses an Anc80 adeno-associated viral vector to deliver the anti-VEGF gene, which is intended to inhibit vascular endothelial growth factor and potentially reduce tumor growth.
AAVAnc80-antiVEGF via Akouos Delivery Device is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The therapy is in Phase 1 clinical development for vestibular schwannoma.
AAVAnc80-antiVEGF via Akouos Delivery Device is currently in Phase 1 clinical development. It is an investigational gene therapy and has not been approved by the FDA or any other regulatory agency. The therapy is being studied in a Phase 1 clinical trial for vestibular schwannoma.
AAVAnc80-antiVEGF via Akouos Delivery Device is being evaluated in one active Phase 1 clinical trial, identified as NCT06517888. This trial is titled 'Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma' and is currently recruiting participants in the United States. The trial is a controlled study with an estimated enrollment of 27 participants.