AskBio initiates phase 2 Parkinson’s trial recruitment
Betsy Goodfellow | June 26, 2024 | News story | Research and Development | AskBio, Neurology, Parkinson's disease, clinical trial
Asklepios BioPharmaceutical (AskBio), a subsidiary of Bayer, has announced that it has initiated the recruitment for its phase 2 REGENERATE-PD study, which will assess the safety and efficacy of AB-1005 for the treatment of moderate-stage Parkinson’s disease.
AB-1005 is an investigational adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy, which previously met its primary endpoint of the safety of a one-time bilateral delivery for Parkinson’s treatment in a phase 1b trial. The drug appeared to be well tolerated with no serious adverse events that were considered related to AB-1005 being reported in all 11 patients at the 18-month mark.
Alan Whone MD PhD, consultant senior lecturer in movement disorder at Bristol Medical School, honorary consultant neurologist at North Bristol Trust, UK, and principal investigator on the REGENERATE-PD programme in the UK, commented: “By enhancing levels of a naturally occurring growth factor, glial cell line-derived neurotrophic factor (GDNF) gene therapy is intended to promote the survival and functioning of vulnerable brain cells that degenerate in Parkinson’s disease. The advancement of AB-1005 is a significant milestone in the development of a gene therapy for Parkinson’s disease and has the potential to bring an effective treatment one step closer to patients.”
Krystrof Bankiewicz MD PhD, scientific chair of Parkinson’s and MSA at AskBio, added: “Following the encouraging results from the phase 1b study and the presentation of 18-month data at the American Association of Neurology (AAN) meeting in April, we are excited to be progressing AB-1005 to this larger, phase 2 study. This latest advancement highlights our confidence in the potential of AB-1005 to provide a transformative impact for patients with Parkinson’s disease.”
Betsy Goodfellow
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