Adverum Biotechnologies Pushes Back Start of Study Enrollment For A1AT Deficiency Drug

Adverum Biotechnologies (ADVM) said enrollment for its Phase 1/2 clinical trial of ADVM-043, a gene therapy for Alpha-1 antitrypsin deficiency, will launch in Q4 2017. Upon release of Q2 results the company said it expected to initiate first in human studies of the drug in the second half of 2016.

The company said it plans to upgrade the manufacturing process for ADVM-043 and will transfer third-party contract manufacturing for the drug to a large-scale contract manufacturer.

Adverum said it will upgrade manufacturing for the drug, formerly known as ANN-001, by implementing its proprietary baculovirus-based production system. The upgrade is designed to increase the production scale and comply with industry standards so that the same production process is used from clinical trials through commercial stage. The company now expects to begin enrollment of patients in the Phase 1/2 clinical trial for ADVM-043 in Q4 2017.

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