SENS-501 / Sensorion - LARVOL DELTA

AUDIOGENE: A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Sensorion | Recruiting ➔ Active, not recruiting

Enrollment closed • Otorhinolaryngology

Efficacy and safety of SENS-501, a dual-AAV otoferlin gene therapy, for DFNB9 congenital deafness. (PubMed, Mol Ther Adv) - "Collectively, these preclinical data support the development of SENS-501 as a safe and efficacious AAV-based treatment for DFNB9. A phase 1/2 clinical trial in children with severe-to-profound hearing loss due to otoferlin mutations is underway."

Journal • Gene Therapies • Otorhinolaryngology

AUDIOGENE: A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Sensorion | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2031 ➔ Jul 2031 | Trial primary completion date: Apr 2027 ➔ Jul 2027

Enrollment open • Trial completion date • Trial primary completion date • Otorhinolaryngology

Preclinical development of SENS‐501 as a treatment for the autosomal recessive non‐syndromic deafness 9 (DFNB9) using an adeno associated vector‐based gene therapy (ESGCT 2023) - "SENS-501 shedding in fluids showed a limited dissemination of the vectors and all the shedding samples decreased over time. The two doses of SENS-501 were well tolerated and did not induce any macroscopic/organ weight changes or local/systemic microscopic findings, Therefore, our nonclinical pharmacology, biodistribution, and safety studies support the clinical development of SENS-501 for hearing loss due to genetic OTOFERLIN protein deficiency."

Gene therapy • Preclinical • Gene Therapies • Otorhinolaryngology • Pain

Preclinical Development of SENS-501 as a Treatment for the Autosomal Recessive Non-Syndromic Deafness 9 (DFNB9) Using an Adeno Associated Vector-Based Gene Therapy (ASGCT 2024) - "The two doses of SENS-501 were well tolerated and no clinical or adverse SENS-501-related effects in the inner ear or outside the inner ear tissue in any evaluation -including immunology- were found. Altogether, our nonclinical pharmacology, safety, biodistribution, and two ongoing natural history studies support the clinical development of SENS-501 and the initiation of our phase I/II clinical trial first half of 2024."

Gene therapy • Preclinical • Gene Therapies • Otorhinolaryngology • Pain

AUDIOGENE: A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Sensorion

New P1/2 trial • Otorhinolaryngology