AskBio Announces First Patient Dosed in Phase 1/2 Trial of AB-1003 Gene
Viralgen Partners with AskBio
August 27, 2019
AskBio and Viralgen have announced that Viralgen has received Current Good Manufacturing Practices (cGMP) certification for its AAV Viralgen manufacturing facility. This certification will allow Viralgen to manufacture AskBio's gene therapy product, AB-1003, for use in clinical trials.
AB-1003 is a gene therapy product that is being developed to treat Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder that affects boys and is characterized by progressive muscle weakness and wasting. AB-1003 is designed to deliver a functional copy of the gene that is mutated in DMD to muscle cells.
The Phase 1/2 trial of AB-1003 is a first-in-human study that will evaluate the safety and efficacy of the product. The trial will enroll up to 12 patients with DMD. Patients will receive a single administration of AB-1003 and will be followed for up to 3 years.
The initiation of the Phase 1/2 trial of AB-1003 is a significant milestone in the development of this gene therapy product. The results of the trial will provide valuable information about the safety and efficacy of AB-1003 and will help to determine the potential of this product for treating DMD.
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