Sensorion’s Audiogene Phase I/II trial of the SENS-501 gene therapy programme has received a favourable recommendation from the Data Monitoring Committee (DMC) to continue.
The DMC’s decision comes after assessing the first dose level’s safety in six to 31-month-aged children.
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The programme is aimed at treating a certain congenital deafness form caused by otoferlin (OTOF) gene mutations. SENS-501’s intra-cochlear administration was tolerated well, allowing the second dose escalation evaluation part of the trial to proceed.
Sensorion completed the first cohort recruitment of three subjects last December and anticipates concluding the second cohort by the end of the first half of this year.
Sensorion CEO Nawal Ouzren said: “On behalf of the Sensorion team, I wish to thank the DMC members for their review of Audiogene’s safety data generated to date and I am pleased with the DMC’s recommendation to proceed with the trial without modifications.”
The current trial aims to assess the intra-cochlear injection of the gene therapy’s tolerability, efficacy and safety in paediatric subjects with OTOF gene-mediated hearing loss.
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By GlobalDataBy focusing on early childhood, the trial aims to leverage the period of maximum brain plasticity to enhance the chances of young subjects with pre-linguistic hearing loss to develop normal speech and language skills.
The study includes two cohorts receiving two doses, followed by an expansion cohort at the chosen dose.
SENS-501 is stated to introduce the OTOF gene’s functional copy into the hair cells of the inner ear through viral vector technology (AAV), potentially restoring hearing by allowing the normal conversion of sound into electrical signals.
The company’s portfolio also comprises SENS-401 (Arazasetron), a clinical-stage small molecule for treating and preventing hearing loss disorders.
The company is currently conducting a Phase II proof of concept study of SENS-401 to preserve residual hearing in patients with cisplatin-induced ototoxicity (CIO).
In June 2023, Sensorion reported encouraging preliminary outcomes from the Phase IIa trial of SENS-401, aimed at preventing residual hearing loss following cochlear implantation.
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