Gene therapy specialist AskBio Inc, a wholly owned and independently operated subsidiary of German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY), announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009.

The product is an investigational adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease.

With this announcement, the AB-1009 programme progresses to Phase 1/2 and AskBio will commence a clinical trial in the United States to explore the safety of AB-1009. The company anticipates recruiting the first patient in early 2026.

In September 2024, AskBio formed a strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. BBM granted AskBio a sublicence to use the proprietary AAV capsid in the AB-1009 programme and provided AAV vector production services.